COM(2025) 1023 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

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EUROPEAN COMMISSION

Strasbourg, 16.12.2025

COM(2025) 1023 final

2025/0404 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and

reducing the burden of the rules on medical devices and in vitro diagnostic medical

devices, and amending Regulation (EU) 2022/123 as regards the support of the

European Medicines Agency for the expert panels on medical devices and Regulation

(EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its

Annex I

{SWD(2025) 1050-1052 final}

(Text with EEA relevance)

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EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

The medical devices sector is a very diverse and innovative driver of economic growth in

Europe. The sector plays a key role in boosting the competitiveness of the European Union

and ensuring the functioning of the Member States’ healthcare systems and, ultimately,

achieving a high level of public health protection. A medical device can be any instrument,

apparatus, appliance, software, implant, reagent for in vitro use, or any material or article

intended by the manufacturer to be used, alone or in combination with other materials or

articles, for human beings for a medical purpose, e.g. for the diagnosis, treatment, alleviation,

prevention, monitoring, prediction or prognosis of a disease, injury or other condition.

Medical devices cover a wide range of products, such as sticking plasters, syringes, surgical

masks, eyeglasses, wheelchairs, medical apps, body scanners, and implantable devices such as

heart valves, pacemakers or knee and hip replacement joints. Examples for in vitro diagnostic

medical devices (IVDs) include influenza or COVID-19 tests, HIV tests, gene mutation tests

or blood grouping tests. According to the World Health Organization, there are an estimated

2 000 000 different kinds of medical devices on the global market, categorised as belonging

to more than 7 000 generic device groups1. There are more than 38 000 medical technology

companies in Europe. Small and medium-sized enterprises (SMEs) make up around 90% of

the industry, most of which are small and micro-sized companies which employ fewer than 50

people. Altogether, the medical technology industry employs more than 930 000 people in

Europe. The European medical technology market was estimated to be worth approximately

EUR 170 billion in 20242.

Regulation (EU) 2017/745 on medical devices (the ‘Medical Devices Regulation’ or ‘MDR’)3

and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the ‘In Vitro

Diagnostic Medical Devices Regulation’ or ‘IVDR’)4 of the European Parliament and of the

Council (collectively referred to in this proposal as ‘the Regulations’) provide a strengthened

regulatory framework for medical devices and in vitro diagnostic medical devices (‘IVDs’).

As set out in their first two recitals, the MDR and IVDR aim to establish a robust, transparent,

predictable and sustainable regulatory framework for medical devices and for in vitro

diagnostic medical devices, which ensures a high level of safety and health while supporting

1 https://www.who.int/health-topics/medical-devices#tab=tab_1 (accessed 17.10.2025). 2 https://www.medtecheurope.org/resource-library/medtech-europes-facts-figures-2025/ (accessed

17.10.2025). The data is for EU27, Iceland, Norway, Switzerland and UK. 3 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical

devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No

1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 4 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro

diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

(OJ L 117, 5.5.2017, p. 176).

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innovation. These Regulations aim to ensure the smooth functioning of the internal market,

taking as a base a high level of protection of health for patients and users, and taking into

account the SMEs that are active in this sector.

To achieve these objectives and to address issues with the previously applicable legislation,

the Regulations have, among other things, set stricter requirements for the level of clinical

evidence that must be gathered by manufacturers to demonstrate compliance of their devices

with the relevant rules. The Regulations also provide for a more robust system of conformity

assessment to check the quality, safety and performance of devices placed on the EU market.

Under the MDR and the IVDR, devices are divided into four risk classes5, depending on their

intended purpose and inherent risks. Depending on the risk class of the device, the

manufacturer must involve an independent third-party conformity assessment body (‘notified

body’) in the conformity assessment, before it can affix a CE marking to the device and place

it on the market. When the MDR and IVDR took effect, the number of designated notified

bodies was very low, which created bottlenecks in the mandatory pre-market certification

process. To date, 51 notified bodies have been designated under the MDR and 19 under the

IVDR.

The MDR took effect on 26 May 20216, and the IVDR on 26 May 2022. The much stricter

requirements established by the Regulations, which also apply to existing devices, the limited

certification capacity of the notified bodies and the insufficient preparedness of the

manufacturers posed the risk of supply shortages and disappearance of critical devices from

the market. Therefore, the transitional period specified in Article 120 of the MDR has been

extended by Regulation (EU) 2023/6077 and will end either on 31 December 2027 or on

31 December 2028, depending on the device’s risk class and subject to certain conditions. The

transitional periods specified in Article 110 of the IVDR have been extended by Regulation

(EU) 2022/1128 and by Regulation (EU) 2024/18609; they will end on either

5 Medical devices are classified in class I (low risk), class IIa (low to medium risk), class IIb (medium to

high risk) and class III (high risk); IVDs are classified in class A (low individual and low public health

risk), class B (moderate individual and low public health risk), class C (high individual and moderate

public health risk) and class D (high individual and high public health risk). 6 Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending

Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its

provisions (OJ L 130, 24.4.2020, p. 18) had postponed the date of application of Regulation (EU)

2017/745 from 26 May 2020 to 26 May 2021 due to the COVID-19 outbreak and the associated public

health crisis. 7 Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending

Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical

devices and in vitro diagnostic medical devices (OJ L 80, 20.3.2023, p. 24). 8 Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending

Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical

devices and the deferred application of conditions for in-house devices (OJ L 19, 28.1.2022, p. 1). 9 Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending

Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation

to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in

vitro diagnostic medical devices (OJ L 2024/1860, 9.7.2024).

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31 December 2027, 31 December 2028 or 31 December 2029, depending on the IVD’s risk

class and subject to certain conditions, which are similar to those provided for in the MDR.

The repeated extension of the transitional periods was only a short-term solution to mitigate

the risk of shortages. It could not solve the underlying structural problems in the

implementation of the MDR and IVDR. In view of the many challenges in the implementation

of the two Regulations, in 2024 the European Commission launched a targeted evaluation of

the MDR and IVDR. Despite the significant progress that has been made in the practical

implementation of the MDR and IVDR, the targeted evaluation (which is being finalised at

the same time as this proposal) has identified shortcomings in the regulatory framework.

These weaknesses affect the availability of devices and the competitiveness of EU

manufacturers (in particular of the many micro, small and medium-sized companies) and

hinder innovation in medical technology. This, in turn, has a negative impact on healthcare

quality and patient safety. The results of the targeted evaluation are presented in Section 3 of

this explanatory memorandum.

This proposal aims to streamline and future-proof the regulatory framework. Its main

objective is to simplify the applicable rules, reduce the administrative burden on

manufacturers and enhance the predictability and cost-efficiency of the certification procedure

by notified bodies, while preserving a high level of public health protection and patient safety,

and thus to help achieve the initial objectives of the Regulations. The objectives of the MDR

and IVDR are still pursued by all relevant actors. However, the lack of sufficiently predictable

timelines for the certification process and the diverging practices across the EU continue to

undermine the efficiency of the process to obtain the CE marking. Moreover, several

requirements under the Regulations are disproportionate to the actual risks posed by the

devices, which results in unnecessarily high costs and burdens. Overly onerous requirements

may prompt manufacturers, especially SMEs, to discontinue supplying devices or to delay

their launch, with potential negative consequences for patient care and public health. They

may also negatively impact the competitiveness of the EU medical devices market compared

to other jurisdictions around the world.

This proposal is a response to requests from the European Parliament10, several Member

States11 and numerous stakeholders for a simplification of the regulatory framework for

medical devices and for measures to ensure the availability of devices. A new regulation is

needed to remedy the problems that have been identified, which otherwise would have a

considerable impact on the medical devices market and, consequently, on the quality of

healthcare provided to patients in the EU.

10 European Parliament resolution of 23 October 2024 on the urgent need to revise the Medical Devices

Regulation (2024/2849(RSP)) (OJ C, C/2025/485, 29.1.2025

ELI: http://data.europa.eu/eli/C/2025/485/oj). 11 Joint paper of Croatia, Finland, France, Germany, Ireland, Luxembourg, Romania, Malta and Slovenia

on necessary reforms in MDR and IVDR: priorities / main points (Council of the European Union,

28.11.2024, 15380/24).

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The proposal aims to improve the functioning of the current regulatory framework, in

particular as regards the smooth functioning of the single market, while ensuring a high level

of health protection for patients. It builds on the key features of the existing framework,

notably the decentralised approach (whereby responsibilities are allocated to the Member

States) and the involvement of notified bodies in the conformity assessment procedure, like in

other EU legislation based on the New Legislative Framework. However, the aim is to

establish a leaner and more cost-effective regulatory framework and to promote further

harmonisation, creating a more competitive and innovative EU market.

The Medical Device Coordination Group (MDCG) was established in accordance with Article

103 of the MDR and is composed of representatives of the national competent authorities and

chaired by the Commission. In the proposal, the MDCG is retained as the main governing

body.

The proposal strengthens the coordination between notified bodies through the coordination

group (NBCG-Med) which was established in accordance with Article 49 of the MDR and

creates a direct reporting line from the NBCG-Med to the MDCG. While notified bodies will

remain under the responsibility of the Member States, the proposal aims to improve the

oversight and regular monitoring of notified bodies through involvement of experts from the

Commission and other Member States.

Expert panels12 have been introduced by the MDR to provide scientific and clinical advice

relating to medical devices and IVDs, as well as to provide opinions on the clinical evaluation

assessment reports drawn up by notified bodies for certain high-risk devices and on the

performance evaluation reports concerning certain high-risk IVDs. Since 2022, the European

Medicines Agency (EMA) has provided the secretariat for the expert panels13. The proposal

aims to broaden the scope of expertise available in the expert panels and expand their

advisory function in regulatory decision-making. In addition, the Commission’s proposal also

includes support from the EMA to the competent authorities to improve coordination between

them, especially with regard to borderline cases and classification issues, derogations from

applicable conformity assessment procedures and possibly other requirements, clinical

evaluations and investigations, vigilance and market surveillance.

• Consistency with existing policy provisions in the policy area

Given the urgent need to take action, the proposal is presented as an immediate follow-up to

the targeted evaluation of the MDR and IVDR. It pursues similar objectives as the

Commission proposals adopted in April 2023 for a reform of the EU pharmaceuticals

legislation14. Consistency with the proposed regulations replacing Directive 2001/83/EC and

Regulation (EU) No 726/2004 is ensured. This proposal is also consistent with the

12 European Commission website, Medical Devices – Expert Panels - Overview 13 Article 30 of Regulation (EU) 2022/123 on a reinforced role of the European Medicines Agency in

crisis preparedness and management for medicinal products and medical devices. 14 Reform of the EU pharmaceutical legislation - Public Health

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Commission proposal for a Biotech Act15, scheduled for adoption at the same time as this

proposal, which contains, among other things, proposed amendments to the Clinical Trials

Regulation16, such as a coordinated assessment procedure for combined studies involving

medicinal products, IVDs and/or medical devices. This proposal also aligns the relevant

MDR provisions with the new Regulation on substances of human origin (SoHO)17.

• Consistency with other Union policies

The proposal contributes to the achievement of the Commission’s objective to improve the

EU’s competitiveness by making business easier and supporting research and innovation. The

Competitiveness Compass18 reiterates the need to simplify the regulatory environment, to

reduce burden and to foster innovation, in particular in technology-based sectors.

The Communication entitled ‘A simpler and faster Europe’19 has set new targets for the

reduction of administrative burden and for prioritising new simplification measures.

This proposal is also consistent with the Commission’s Strategy for European Life Sciences20,

which pointed out that the risks of losing competitiveness to other regions are especially high

in areas such as medical devices, as legislation is not sufficiently innovation-friendly, future-

proof and lacks clear paths to access markets. The Commission therefore committed

to propose a legislative initiative striking the balance between simplifying EU regulations

related to medical devices and in vitro diagnostics, and effectively protecting patient safety

and public health, also considering health emergencies.

The proposal is consistent with EU policies in the fields of safety, health and environment, as

it safeguards a high standard of patient safety and public health protection, while reducing

overly burdensome requirements and streamlining procedures. The proposal is

complementary to EU policies in the fields of single market and artificial intelligence, as it

lays down regulatory tools which pursue the same objectives as the existing provisions in

those areas.

15 Proposal for a Regulation of the European Parliament and of the Council on establishing a framework

of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the

area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014,

(EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act), COM(2025)1022 of 16

December 2025. 16 Regulation (EU) No 536/2014, ELI: http://data.europa.eu/eli/reg/2014/536/oj. 17 Regulation (EU) 2024/1938, ELI: http://data.europa.eu/eli/reg/2024/1938/oj. 18 Communication from the Commission to the European Parliament, the European Council, the Council,

the European Economic and Social Committee and the Committee of the Regions, A Competitiveness

Compass for the EU, COM(2025)30 final, 29.1.2025. 19 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions, A simpler and faster Europe:

Communication on implementation and simplification, COM(2025)47 final, 11.2.2025. 20 Communication from the Commission to the European Parliament, the European Council, the Council,

the European Economic and Social Committee and the Committee of the Regions, Choose Europe for

life sciences, A strategy to position the EU as world’s most attractive place for life sciences by 2030,

COM(2025)525 final, 2.7.2025.

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2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

As the proposal amends two existing Regulations, the legal basis for the proposal is the same

as that in the Regulations to be amended, namely Article 114 and Article 168(4) point (c) of

the Treaty on the Functioning of the European Union (TFEU). The measures proposed for this

amending regulation have as their objective to preserve and enhance the smooth functioning

of the single market as regards medical devices and in vitro diagnostic medical devices, while

preserving the performance and safety of devices for patients and users.

• Subsidiarity (for non-exclusive competence)

The MDR and IVDR have introduced a common regulatory framework at EU level, as the

objectives of these Regulations could not be sufficiently achieved through national

intervention. These objectives are, specifically, to ensure a high level of protection of health

for patients and users and the smooth functioning of the single market, and to avoid potential

market disruption. To address the identified problems, action at EU level is considered less

costly and more efficient than national measures in all Member States. For this reason, the

proposed amendments to the MDR and IVDR must be made at EU level.

• Proportionality

The proposed amendments do not go beyond what is necessary to achieve the objectives of

simplification and burden reduction to ensure that the intended purpose of both Regulations

can be attained. That purpose is to establish a robust, transparent, predictable and sustainable

regulatory framework for medical devices and for in vitro diagnostic medical devices which

guarantees a high level of protection of public health and patient safety and the smooth

functioning of the single market for such devices.

• Choice of instrument

The Commission proposes a regulation of the European Parliament and of the Council. This is

the most suitable legal instrument as only a regulation, with its uniform application, binding

nature and direct applicability, can provide the necessary degree of uniformity needed to

improve the functioning of the single market as regards medical devices and in vitro

diagnostic medical devices.

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3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations / fitness checks of existing legislation

The Commission has just concluded a targeted evaluation of the Regulations21. This proposal

draws on the findings of the evaluation.

Overall, the evaluation found that the benefits of the Regulations for patients and healthcare

systems are materialising by strengthening device safety and performance and increasing

transparency. However, these achievements come at high and often disproportionate

compliance costs, caused also by high regulatory complexity.

The evaluation found that the Regulations have strengthened the regulatory framework

through stricter requirements on the designation and oversight of notified bodies, the conduct

of conformity assessments, and the generation of clinical evidence. However, the three

dimensions are closely interlinked, and weaknesses in one area affect the entire system. A

fragmented and lengthy designation process reduces available capacity and creates

inconsistencies in oversight, which in turn contributes to divergent conformity assessment

practices. At the same time, incomplete or unevenly assessed clinical evidence prolongs

assessments and undermines predictability, while limiting the ability to demonstrate that the

Regulations’ safety objectives are met. Although progress is evident, the combined effect of

capacity constraints, fragmented oversight and uneven evidence requirements means that

efficiency, harmonisation and effectiveness remain below expectations. This has led to a

perceived unpredictability and disproportionality of the regulatory framwork, undermining

trust of stakeholders in the system. More precisely, the evaluation shows that this results in a

decrease in the availability of certain devices (e.g. innovative and niche devices), which has a

negative impact on the protection of patients and industrial competitiveness.

The evaluation highlights several shortcomings and inefficiencies in the current regulatory

framework, particularly regarding simplification and streamlined procedures. A fragmented

and disharmonised regulatory framework has resulted in several inefficiencies and

unnecessary burdens for stakeholders, who call for a more centralised governance structure.

An unanticipated increased administrative burden appears to originate from redundant

reporting and unnecessary duplication of work, posing significant challenges for stakeholders.

The unpredictability and disproportionality of the system further compound these concerns,

particularly for economic operators seeking clarity and consistency in requirements that

would make it possible to foster innovation without compromising safety. In addition, digital

solutions are often cited as potential avenues to alleviate some of these burdens, enhance

efficiency and reduce resource constrains. The fragmentation of governance structures,

21 Commission Staff Working Document on the Targeted evaluation of Regulation (EU) 2017/745 on

Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices,

SWD(2025)1051.

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overlapping reporting requirements and limited digitalisation identified contribute to

increased administrative and adjustment costs for both authorities and economic operators.

In summary, the targeted evaluation shows that:

• certain requirements, especially in relation to conformity assessment procedures, are

overly complex, burdensome, lengthy and costly;

• the application of legal requirements by national authorities and notified bodies is not

sufficiently aligned;

• current coordination mechanisms are not sufficiently efficient and effective;

• there is no sufficient technical-regulatory advice available at EU level;

• adaptive pathways for breakthrough innovation and orphan or ‘niche’ devices do not

exist;

• the Regulations have unintended negative impacts on innovation, competitiveness

and patient care;

• there is a need for improved coherence with other EU law, such as the Clinical Trials

Regulation.

The evaluation has demonstrated that there is a potential to simplify and to reduce burden

relating to the implementation of both Regulations, without undermining their main

objectives.

• Stakeholder consultations

In addition to the continuous consultations with Member States and stakeholders taking place

as part of the Medical Devices Coordination Group, and the public and targeted consultation

activities informing the targeted evaluation, the Commission launched a call for evidence on

the targeted revision of the MDR and IVDR.

It was possible to submit feedback from 8 September to 6 October 202522. A total of 427

individual submissions23 and 166 attachments24 were considered valid (the final analysis was

based on 165 of these attachments)25.

22 European Commission, Medical devices and in vitro diagnostics – targeted revision of EU rules, Have

Your Say webpage. 23 The figures include one contribution discarded as not respecting the feedback rules; five contributions

from four contributors were removed as considered duplicates, and 14 contributions were merged into

six contributions as considered complementary feedback. 24 As part of the 171 attachments received in the call for evidence, five were not taken into account in the

analysis (one attachment from the discarded feedback, two attachments were part of the above

duplicates and one document was sent three times by one contributor). 25 One attachment sent three times by one contributor was considered off-topic.

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In terms of stakeholder groups, companies and businesses were the largest contributors (199

contributions, 46.6%) followed by business associations (61 contributions, 14.29%). The

other respondents were non-governmental organisations (36 contributions, 8.43%), academic

and research institutions (31 contributions, 7.26%), public authorities (13 contributions,

3.04%) and trade unions (6 contributions, 1.41%). Feedback was also provided by notified

bodies (5 contributions, 1.17%) and consumer organisations (1 contribution), as well as by

individuals (37 submissions from EU citizens (8.67%) and 8 from non-EU citizens (1.87%)).

Some stakeholders selected the option ‘Others’ (30 contributions, 7.03%). A large majority of

contributing companies/businesses represented SMEs (129 contributions , 64.8%) including

34 medium-sized, 54 small and 41 micro-sized companies.

In terms of geographical scope, the respondents were mostly from Germany (100

submissions, 23.42%), Belgium (48 submissions, 11.24%) and France (39 submissions,

9.13%).

Feedback to the call for evidence indicated that respondents agreed with the identified hurdles

stemming from the Regulations. They referred to their disproportionate costs, high

administrative burden and overall regulatory complexity, also echoing the findings of the

targeted evaluation. Stakeholders showed overall broad support for measures aiming at

simplifying and making the regulatory framework more proportionate and efficient, reducing

administrative burden, and allowing for more flexibility to support innovative devices to reach

the market.

Respondents across all stakeholder groups overall recognized the objectives of the

Regulations and stressed that maintaining safety standards and a high level of public health,

including by ensuring the availability of devices or by supporting innovation for small

population groups, should remain at the centre of the revision.

Overall, stakeholders underlined the need for a risk-based approach to requirements,

supported greater digitalisation and a more efficient governance. Feedback included proposed

changes related to several areas, including clinical and post-market data requirements,

simplification and greater predictability of the conformity assessment process, as well as

changes related to audits and post-market surveillance

Feedback also particularly emphasized the implications of the Regulations for SMEs as costs

to comply with the requirements are viewed as particularly disproportionate for SMEs; many

stakeholders are asking for SMEs’ needs to be taken into account.

Some stakeholders were also in favour of greater use of digital tools. There were also

requests for simplified and enhanced governance, including to improve the predictability and

ensure a harmonised interpretation of the regulatory system.

Finally, stakeholders supported measures enhancing the consistency with other EU legislative

frameworks, such as, EU legislation on clinical trials and artificial intelligence.

The Commission also launched a series of targeted surveys, including one survey dedicated to

small and medium-sized manufacturers of medical devices, and organised several workshops.

• Collection and use of expertise

The proposal is based on the findings of the targeted evaluation and the stakeholder

consultations described above.

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• Impact assessment

The proposal addresses the issues identified during the targeted evaluation. The proposed

revision of the MDR and IVDR consists of targeted simplification measures (for which there

are no viable alternatives), that seek to reduce burden and ensure greater predictability of the

legislative framework. The proposed amendments do not intend to modify the objectives of

the legislation, thus ensuring the continued availability of safe and innovative devices and

safeguarding a high level of patient safety, public health and healthcare. In this context, an

impact assessment was not deemed necessary nor appropriate, in terms of timing and

efficiency.

Instead, the proposal is accompanied by a Commission staff working document which

explains the proposed measures and presents the evidence and its analysis, as well as

stakeholders’ views. That Commission staff working document contains a cost-savings

estimate26. Overall, the combined quantifiable impact of the simplification measures

described in that document, taking into account the limitations and assumptions outlined

throughout, is estimated to reach more than €3 billion per year. Alongside financial relief, the

measures aim to put in place a proportionate, efficient and flexible framework, increase legal

certainty, support more coherent implementation across the Union and sustain the high level

of health protection set out in the MDR and IVDR. By supporting a more efficient and

innovation-friendly system, the proposed measures ultimately help ensure that patients

continue to have access to the devices they need.

• Regulatory fitness and simplification

The proposal contributes to the Commission’s commitment to simplify EU legislation and to

reduce regulatory burden for people, businesses and administrations in the EU, improving its

competitiveness and resilience.

The proposal to streamline procedures and to reduce the burden on manufacturers, distributors

and notified bodies is expected to decrease compliance costs for SMEs, large companies and

other stakeholders in the relevant sectors. The simplification of administrative procedures will

significantly reduce uncertainty, ensuring greater predictability for companies, allowing them

to plan their research and development activities more efficiently. The more streamlined

processes for certification and for oversight of notified bodies will boost the competitiveness

of the relevant EU sectors, particularly for SMEs, which will be able to respond more quickly

to the changing market conditions and customer needs. More efficient and predictable

processes will make the EU companies concerned more attractive to both domestic and

foreign investors which could lead to increased investment and growth in the sector.

26 Commission Staff Working Document on Cost-savings, SWD(2025)1050.

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• Fundamental rights

The proposal respects the fundamental rights and principles laid down in the Charter of

Fundamental Rights of the European Union27. In particular, it maintains the right of each

person to respect for their physical and mental integrity (Article 3), the protection of personal

data (Article 8) and the freedom to conduct a business (Article 16) and the right to property

(Article17). Moreover, the proposed simplification measures, the expected reduction in

administrative burden and the measures to support patient-centred innovation and the

availability of devices, including those for small patient populations, support the right of

access to preventive care and the right to benefit from medical treatments. They also ensure a

high level of human health protection, as laid down in Article 35 of the Charter.

4. BUDGETARY IMPLICATIONS

The proposal has budgetary implications for the EU, primarily with regard to additional

resources needed to ensure: (1) a stronger oversight of notified bodies and a uniform

application of the regulatory framework; (2) access to external additional scientific, technical

and regulatory expertise to support evidence-based decision-making; and (3) support from the

European Medicines Agency (EMA) for better coordination of activities undertaken by

national authorities in relation to the implementation of the MDR and IVDR, in particular in

the areas of vigilance and market surveillance, borderline and classification decisions, clinical

investigations and performance studies, and derogations in exceptional cases relating to

patient health and safety. The ‘financial statement’ provides detailed information about the

budgetary implications and the human and administrative resources required. This approach

leverages the established role of expert panels and the EMA to efficiently address the needs of

the sector within the current system framework, thereby drawing on the strengths of existing

EU regulations.

The proposal authorises the Commission to set fees for certain activities required under the

existing MDR and IVDR and the proposed amendments, such as the assessment and

monitoring of notified bodies and the provision of scientific and regulatory advice. Those

activities may therefore be funded, at least partially, through fees, with the possibility to

introduce reduced rates for SMEs. However, other activities, especially those relating to

improved coordination among national authorities to improve the functioning of the single

market and simplify compliance for economic operators, cannot at this stage be financed from

the financial contributions of the entities subject to the regulatory framework. A specific rule

for user fees is needed, as such rules exist in other sectors in the EU and other jurisdictions.

The impact on the EU budget of the costs of enhanced coordination will eventually reduce

costs for economic operators thanks to benefits stemming from uniform practices in the

singlemarket, streamlined procedures and a more robust and predictable regulatory

infrastructure that enhances competitiveness and stimulates innovation. Moreover, the

27 EUR-Lex - 12012P/TXT - EN - EUR-Lex

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proposed amendment strengthens the EU's ability to effectively prevent and respond to public

health threats, such as shortages in the supply of medical devices and safety concerns, thereby

minimising the costs associated with any inefficiencies in the regulatory framework.

Crucially, this effort also aims to simplify existing regulations, reduce administrative burdens,

and refine the certification processes for notified bodies, leading to a significant reduction in

overall expenses for manufacturers, all while safeguarding public health and patient safety.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The impact of the proposal will be monitored through existing reporting and oversight

mechanisms, as part of the regular follow-up measures set out in the Regulations. In addition,

the Commission proposes to carry out another evaluation of the application of the MDR and

IVDR five years after the proposed amendments enter into effect.

• Detailed explanation of the specific provisions of the proposal

The proposal is structured as follows:

Article 1: Amendments to Regulation (EU) 2017/745

Article 2: Amendments to Regulation (EU) 2017/746

Article 3: Amendments to Regulation (EU) 2022/123

Article 4: Amendments to Regulation (EU) 2024/1689

Article 5: Entry into force

The amendments can be summarised as follows, by main topic, Articles concerned and

specific provisions of the proposal:

Amendments to Regulation (EU) 2017/745 on medical devices (MDR) and to

Regulation (EU) 2017/746 (IVDR)

TOPIC 1: SIMPLIFICATION AND PROPORTIONALITY

Articles Specific provisions of the proposal

Person responsible for regulatory compliance

(PRRC) (MDR: Article 15, IVDR: Article

15)

Removal of the detailed qualification

requirements for the PRRC and removal of

the obligation that SMEs, which rely on an

external PRRC, need to have the PRRC

‘permanently and continously’ available, but

only available.

Validity of certificates and recertification

(MDR: Article 56, IVDR: Article 51)

The maximum period of validity of

certificates (currently 5 years) is removed.

Instead of recertifying devices, notified

bodies will carry out periodic reviews

proportionate to the risk of the device while

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the certificate is valid.

Clinical evidence, non-clinical data and

clinical data (MDR: Article 2, point 48,

Article 61, Annex II, Annex XIV , IVDR:

Annex XIII)

A wider range of data may qualify as clinical

data. The conditions for relying on clinical

data of an equivalent device are made more

flexible. In Article 61 MDR, the possibility

to demonstrate a device’s safety and

performance based on non-clinical data alone

is expanded. The use of ‘New Approach

Methodologies’, such as in silico testing, is

promoted.

Well-established technologies (MDR: Article

2, point 72, Article 18, Article 32, Article 52,

Article 61, Article 86)

A definition of ‘well-established technology

device’ is introduced for devices which will

be subject to more proportionate

requirements, replacing the lists of devices in

the current Articles 18(3), 52(4) and 61(6)(b)

MDR.

Repackaging and relabelling (MDR : Article

16, IVDR: Article 16)

The requirements for a notified body

certificate for relabelling and repackaging

activities, as well as the prior notice

obligation, are removed.

Classification rules (MDR: Annex VIII) Some classification rules are adapted

resulting in lower risk classes for certain

devices, such as reusable surgical

instruments, accessories to active

implantable devices and software.

TOPIC 2: REDUCTION OF ADMINISTRATIVE BURDEN

Articles Specific provisions of the proposal

Summary of safety and (clinical)

performance (MDR: Article 32, IVDR:

Article 29)

The scope of devices for which the

manufacturer must provide a summary of

safety and (clinical) performance (SS(C)P) is

reduced to those devices for which the

notified body must conduct a technical

documentation assessment. As the draft

SS(C)P is part of the documentation to be

submitted to the notified body, a separate

validation by the notified body is no longer

required.

Periodic Safety Update Report (MDR:

Article 86, IVDR: Article 81)

The frequency according to which

manufacturers are obliged to update periodic

safety update reports (PSUR) is reduced. The

review of the PSUR by the notified body will

be part of its surveillance activities.

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Reporting timeline of certain serious

incidents in the framework of vigilance

(MDR: Article 87, IVDR Article 82)

Manufacturers will have 30 days (instead of

15 days) for reporting serious incidents

which are not related to public health threats,

death or serious deterioration of health.

Changes after certification (MDR: Annex

VII, IVDR: Annex VII)

Notified body must distinguish between

changes regarding the quality management

system or the approved device that

manufacturers can implement without prior

notification, without prior approval or only

after approval by the notified body. Where

appropriate, notified body and manufacturer

shall agree on a predetermined change

control plan.

Authorisation or notification of certain

performance studies (IVDR: Article 58)

Performance studies involving only routine

blood draws will not be subject to prior

authorisation. The notification of

performance studies on companion

diagnostics using left-over specimens will be

removed.

TOPIC 3: INNOVATION AND AVAILABILITY OF DEVICES FOR SPECIAL PATIENT

GROUPS OR SITUATIONS

Articles Specific provisions of the proposal

In-house devices (MDR: Article 5(5), IVDR:

Article 5(5))

The conditions for the manufacture and use

within health institutions are made more

flexible, e.g. allowing the transfer of in-

house devices if this is in the interest of

patient safety or public health). Under the

IVDR, the condition that there is no

equivalent device on the market is removed.

Central laboratories manufacturing and using

tests exclusively for clinical trials are added

to the scope of the in-house device

exemption.

Interruption or discontinuation of supply of

certain devices (MDR: Article 10a, IVDR:

Article 10a)

A central IT tool for the reporting and

information exchange will be provided in

Eudamed or interoperable with Eudamed.

EMA will develop a methodology to identify

devices falling within the scope of the

reporting obligation and draw up a list of

such devices.

Conformity assessment procedures for

breakthrough devices or orphan devices

(MDR: new Article 52a, IVDR: new Article

Criteria for breakthrough devices and orphan

devices are introduced. After ‘designation’ by

an expert panel, breakthrough devices and

orphan devices will be subject to a priority

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48a) and rolling review. Manufacturers have

access to expert panels’ advice.

Derogations for public health emergencies,

disasters or crises (MDR: Article 59, new

Article 59a, IVDR: Article 54, new Article

54a)

The Commission may authorise the placing

on the market of devices in the event of a

public health emergency on its own initiative.

Competent authorities may authorise

derogations from manufacturing, design or

intended purpose of CE-marked devices

during serious cross-border health threats,

disasters or crises.

Regulatory sandboxes (MDR: new Articles

59b and 59c, IVDR: new Articles 54b and

54c)

Member States and the Commission may

establish regulatory sandboxes to address

needs of emerging technologies.

Reprocessing of single-use devices (MDR:

Article 17)

Manufacturers will be obliged to provide a

justification for a ‘single-use’ claim. All

devices that are not intended for single-use

can be reprocessed in accordance with the

instructions provided by the manufacturer. A

person who fully refurbishes a single-use

device will be the manufacturer of the fully

refurbished device. The provision will

become applicable five years after entry into

force.

Kits (IVDR: new Article 19a) Clarification regarding the composition of

kits as defined in Article 2(11) IVDR.

‘Grandfathering’ of legacy orphan devices

(MDR: Article 120, IVDR: Article 110)

Orphan devices that were CE marked under

the former Directives and for which an

expert panel has confirmed that they meet the

criteria of ‘orphan device’ may continue to be

placed on the market beyond the transitional

periods, subject to conditions.

Nanomaterial (MDR: Annex I, Annex VIII) The outdated definition of nanomaterial in

Article 2 MDR will be deleted and replaced

by a reference to the Commission

Recommendation of 10 June 2022 on the

definition of nanomaterial in the provisions

of Annex I and Annex VIII concerning

nanomaterial.

TOPIC 4: PREDICTABILITY AND COST-EFFICIENCY OF CERTIFICATION

Articles Specific provisions of the proposal

Structured dialogue (MDR: Annex VII, A legal basis for notified bodies and

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IVDR : Annex VII) manufacturers to conduct, pre- and post-

submission, a structured dialogue based on

documented procedures will be introduced.

Conformity assessment procedures (MDR:

Article 52, Annexes IX, X, XI, IVDR:

Article 48, Annexes IX, X, XI)

The involvement of notified bodies in the

conformity assessment of lower and medium

risk devices (class IIa and IIb and class B and

C) will be reduced (technical documentation

assessment of one representative device for a

generic device group, for a category or for

the entire portfolio). No systematic technical

documentation assessment of representative

devices will be required during surveillance

activities. Class A sterile IVD will not require

notified body involvement.

Notified bodies will have the possibility to

replace on-site audits by remote audits.

Where justified due to absence of safety

issues, surveillance audits should be

conducted only every two years.

Unannounced audits should be conducted

‘for-cause’.

Reduced timelines for consultation of

medicinal products and SoHO authorities.

Clinical evaluation consultation procedure

(MDR: Article 54), performance evaluation

consultation procedure and early advice

(IVDR: Article 48, new Article 56a)

The scope of the CECP will be limited to

class III implantable devices with the

empowerment of the Commission to add

other types of devices by delegated act.

The PECP will be removed. Instead, the

possibility of early advice from expert panels

for class C and D IVDs will be introduced.

Notified body fees (MDR: Article 50) Fee reductions for micro and small

manufacturers and for orphan devices. The

Commisison will be empowered to set level

and structure of notified body fees.

TOPIC 5: COORDINATION WITHIN DECENTRALISED SYSTEM

Articles Specific provisions of the proposal

Regulatory status of products and

classification of devices (MDR: Article 4,

new Article 4a, new Article 51a, new Article

51b, IVDR: Article 3, new Article 3a, new

Article 47a, new Article 47b,)

The coordination among competent

authorities regarding the qualification of a

product and the classification of a device

(‘Helsinki procedure’) will be codified, with

the possibility to request opinions from

expert panels.

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Designation and monitoring of notified

bodies (MDR: Article 36-44, IVDR: Article

31 referring to the MDR provisions)

The assessment of applications from

conformity assessment bodies and he

designation/notification of notified bodies

will be streamlined with the involvement of

joint assessment teams composed of the

national authority responsible for notified

bodies, experts nominated by the

Commission and experts nominated from

other Member States.

Joint assessment teams will be involved in

the monitoring of notified bodies after they

have been designated, at least every two

years.

The full reassessment of notified bodies

every five years will be removed.

The Commission will be empowered to set

the level and structure of fees and

recoverable costs for the designation and

monitoring of notified bodies.

Dispute resolution mechanism between

manufacturers and notified bodies (MDR:

Article 35, IVDR: Article 31 referring to the

MDR provisions)

The authority responsible for notified bodies

will have an ‘ombudsperson’ role in case of

disputes between manufacturers and notified

bodies.

Coordination of notified bodies (MDR:

Article 49, Article 31 referring to the MDR

provisions)

The obligation of notified bodies to

participate in the notified bodies coordination

group (NBCG-Med) will be strengthened.

NBCG-Med will report to the MDCG.

Enhanced role of external expertise available

to the regulatory system (MDR: Article 106,

new Article 106a IVDR: Article 100)

The role of expert panels and their

composition will be broadened, involving

them e.g. in determination of the regulatory

status of products and classification of

devices. Expert panels should be able to

provide scientific, technical, clinical and

regulatory advice to the Commission,

Member States, the MDCG, notified bodies

and in certain cases to manufacturers. The

EMA will continue to provide the secretariat

for the expert panels.

The functions of expert panels and expert

laboratories, currently regulated together in

Article 106 MDR, will be clarified through a

separate provision on expert laboratories.

Support from the EMA for the coordination The EMA will provide scientific technical

EN 18 EN

of competent authorities (MDR: new Article

106b)

and administrative support for the

coordination among national competent

authorities in several areas, such as

borderline and classification, multi-country

clinical studies, derogations, vigilance and

market surveillance.

EMA will also provide support to SMEs.

TOPIC 6: FURTHER DIGITALISATION

Articles Specific provisions of the proposal

Digitalisation of compliance tools (MDR:

Article 19, new Article 110a, Annex I, Annex

VI, IVDR: Article 17, new Article 103a,

Annex I, Annex VI)

The EU declaration of conformity may be

provided in digital form.

Subject to future implementing rules, certain

information on the label may be provided in

digital form.

Manufacturers of near-patient tests will be

able to provide electronic instructions for

use.

The submission of information pursuant to

MDR/IVDR shall be performed

electronically.

Economic operators need to provide their

digital contact in Eudamed.

Digitalisation of conformity assessment

(MDR: new Article 52b, IVDR: new Article

48b)

Manufacturers may draw up technical

documentation, report and other documents

in digital form.

Online sales (MDR: Article 6, IVDR: Article

6)

Certain essential information necessary to

identify the device and the instructions for

use have to be provided in case of online

sales.

UDI and Eudamed (MDR: Article 27-33,

Annex VII, IVDR: Article 24-30, Annex VII)

The provisions on UDI assignment and

registration in Eudamed have been clarified.

It is made possible that certain electronic

systems may be set up outside Eudamed.

TOPIC 7: INTERNATIONAL COOPERATION

Articles Specific provisions of the proposal

International cooperation and reliance

mechanisms (MDR: new Article 108a and

A new section on international cooperation is

introduced promoting activities aiming at

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new Article 108b) global regulatory convergence and

international cooperation, such as the

International Medical Device Regulators

Forum (IMDRF) and the Medical Device

Single Audit Programme (MDSAP).

TOPIC 8: INTERPLAY WITH OTHER UNION LEGISLATION

Articles Specific provisions of the proposal

Combined studies involving medicinal

products, medical devices and/or IVDs

(MDR: new Article 79a, IVDR: new Article

75a)

For combined studies, the sponsor may

submit a single application, triggering a

coordinated assessment, in accordance with

Regulation (EU) No 536/2014 on clinical

trials, which will be amended by the Biotech

Act28 accordingly.

Cybersecurity (MDR: new Article 87a,

Annex I, IVDR: new Article 82a, Annex I)

Serious incidents reported in accordance with

the vigilance system established under the

MDR or IVDR, which also qualify as

actively exploited vulnerabilities and severe

incidents as referred to in Regulation (EU)

2024/2847 on cyberresilience, will be made

available to the relevant national computer

security incident response teams (‘CSIRTs’)

and to the European Union Agency for

Cybersecurity (ENISA). In addition,

manufacturers will have to report actively

exploited vulnerabilities and severe incidents

that do not qualify as serious incidents within

the meaning of the MDR or IVDR to the

CSIRTs and ENISA through Eudamed.

In Annex I MDR/IVDR, cybersecurity will

be explicitly mentioned in the general safety

and performance requirements.

Amendments to Regulation (EU) 2022/123 on a reinforced role for the European Medicines

Agency in crisis preparedness and management for medicinal products and medical devices

28 COM(2025)1022, see above footnote 15.

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Articles Specific provisions of the proposal

Management of expert panels (Article 30) EMA’s mandate to provide the secretariat for

the medical device expert panels is aligned

with changes to the provisions on expert

panels in the MDR.

Amendments to (EU) 2024/1689 on artificial intelligence

Articles Specific provisions of the proposal

Annex I In Annex I to the Artificial Intelligence Act,

the MDR and IVDR are moved from Section

A to Section B.

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2025/0404 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and

reducing the burden of the rules on medical devices and in vitro diagnostic medical

devices, and amending Regulation (EU) 2022/123 as regards the support of the

European Medicines Agency for the expert panels on medical devices and Regulation

(EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its

Annex I

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Article 114 and Article 168(4), point (c), thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee1,

Having regard to the opinion of the Committee of the Regions2,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Regulations (EU) 2017/7453 and (EU) 2017/7464 of the European Parliament and of

the Council establish regulatory frameworks to ensure the smooth functioning of the

internal market as regards medical devices and in vitro diagnostic medical devices,

respectively, taking as a base a high level of protection of health for patients and users.

At the same time, Regulations (EU) 2017/745 and (EU) 2017/746 set high standards of

1 OJ C […], […], p. […]. 2 OJ C […], […], p. […]. 3 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical

devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No

1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1,

ELI: http://data.europa.eu/eli/reg/2017/745/oj). 4 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro

diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

(OJ L 117, 5.5.2017, p. 176, ELI: http://data.europa.eu/eli/reg/2017/746/oj).

EN 22 EN

quality and safety for medical devices and in vitro diagnostic medical devices in order

to meet common safety concerns as regards such devices. Furthermore, both

Regulations significantly reinforce key elements of the previous regulatory framework

set out in Council Directives 90/385/EEC5 and 93/42/EEC6 and in Directive 98/79/EC

of the European Parliament and of the Council7, such as the supervision of notified

bodies, risk classification, conformity assessment procedures, clinical evidence

requirements, vigilance and market surveillance, and require the setting up of the

European database on medical devices (Eudamed) to enable transparency and

traceability in respect of medical devices and in vitro diagnostic medical devices.

(2) The extension of the transitional periods provided for in Article 120 of Regulation

(EU) 2017/745 and Article 110 of Regulation (EU) 2017/746 mitigated the risk of

shortages of medical devices and in vitro diagnostic medical devices in the Union, but

did not address underlying structural problems related to the implementation of both

Regulations.

(3) In its targeted evaluation8 of Regulations (EU) 2017/745 and (EU) 2017/746, the

Commission confirmed that the Regulations have strengthened the regulatory

framework through stricter requirements on the designation and oversight of notified

bodies, the conduct of conformity assessments, and the generation of clinical evidence.

However, the evaluation also highlighted several shortcomings and inefficiencies in

the regulatory framework, resulting in unnecessary burdens for manufacturers. Overly

complex and often disproportionate requirements, costly, lenghthy and unpredictable

conformity assessment procedures affect the availability of devices, the

competitiveness of manufacturers in the Union, in particular of small and medium-

sized enterprises, and innovation in medical technology. This has a negative impact on

the level of healthcare and patient safety in the Union.

(4) To address the shortcomings identified, the existing rules should be simplified, and

administrative burden should be reduced without jeopardising the high level of public

health and patient safety. Moreover, the predictability and cost-efficiency of the

application of both Regulations should be enhanced to achieve their initial objectives.

(5) Regulation (EU) 2017/745 includes in its scope certain groups of devices which are

similar to medical devices but for which the manufacturer claims only an aesthetic or

another non-medical purpose. To enhance legal certainty and to ensure consistency, it

should be clarified that accessories for such products without a medical purpose are

also included within the scope of Regulation (EU) 2017/745.

5 Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to

active implantable medical devices (OJ L 189, 20.7.1990, p. 17,

ELI: http://data.europa.eu/eli/dir/1990/385/oj). 6 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1,

ELI: http://data.europa.eu/eli/dir/1993/42/oj). 7 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro

diagnostic medical devices (OJ L 331, 7.12.1998, ELI: http://data.europa.eu/eli/dir/1998/79/oj). 8 SWD(2025)1051.

EN 23 EN

(6) The provisions in Regulation (EU) 2017/745 should be adapted to Regulation (EU)

2024/1938 of the European Parliament and of the Council9, the new Union legislation

in the area of substances of human origin (SoHO).

(7) To avoid a double layer of regulatory requirements, products that combine a medical

device and an in vitro diagnostic medical device should be subject either to Regulation

(EU) 2017/745 or to Regulation (EU) 2017/746, depending on the product’s principal

mode of action, whilst the general safety and performance requirements of the other

Regulation should apply to the part of the device that has an ancillary function.

(8) The definition of nanomaterial in Regulation (EU) 2017/745 should be updated to

bring it in line with Commission Recommendation of 10 June 2022 on the definition

of nanomaterial10.

(9) Clinical data are an important source of information for demonstrating the safety and

performance of a device. However, the process of generating clinical data is often

lengthy and costly. The definition of clinical data should be broadened to enable the

use of data generated through studies on the device concerned that are published in

scientific literature, but not necessarily peer-reviewed.

(10) Devices that are well-established technologies have a lower risk profile than other

devices of the same risk class. They are therefore subject to certain exemptions or

more proportionate requirements in Regulation (EU) 2017/745. To make the

application of those provisions more flexible and future-proof, a definition of term

well-established technology devices should be included in that Regulation, based on

guidance developed by the Medical Device Coordination Group11, and the existing

lists of devices in Articles 18, 52 and 61 of Regulation (EU) 2017/745 should be

replaced by a reference to the newly defined term.

(11) To ensure legal certainty and to safeguard the principle of free movement of goods, the

coordination mechanism between national competent authorities for decisions on the

regulatory status of a product and on the classification of a device, should be

streamlined and, where appropriate, involve external expertise from an expert panel,

supported by the European Medicines Agency (EMA). The decision on the regulatory

status, however, should remain with the national authorities or, where appropriate,

with the Commission acting through implementing acts.

9 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on

standards of quality and safety of substances of human origin intended for human application and

repealing Directives 2002/98/EC and 2004/23/EC (OJ L 2024/1938, 17.7.2024, ELI:

http://data.europa.eu/eli/reg/2024/1938/oj). 10 Commission Recommendation of 10 June 2022 on the definition of nanomaterial, C/2022/3689 (OJ C

229, 14.6.2022, p. 1). 11 MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE

marked under Directives 93/42/EEC or 90/385/EEC; A guide for manufacturers and notified bodies

(April 2020).

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(12) The manufacture and use of devices within health institutions (‘in-house devices’)

under certain conditions is essential for the provision of health care in cases where the

needs of the target patient group cannot be met by devices available on the market.

While the strict conditions for the exemption of such in-house devices from most of

the requirements set out in Regulation (EU) 2017/745 or Regulation (EU) 2017/746

should in principle remain in place, some flexibility should be introduced in order to

remove unnecessary administrative burden on health institutions, to promote clinical

research on in-house devices and to enable the access of patients to in-house devices

where no alternatives exist. For example, some documentation obligations should be

removed, especially under Regulation (EU) 2017/746 for health institutions accredited

to EN ISO 15189. The transfer of an in-house device to another health institution

should be possible where justified in the interest of public health, patient health or

patient safety. Also, to provide legal certainty for health institutions, when a device

becomes available on the market that serves the target patient group’s needs in an

equivalent manner to the in-house device, the health institution should have a lengthy

transition period until the exemption for in-house manufacturing ceases to apply. Due

to their importance for preparedness and response to public health emergencies, the

condition that no device is available on the market serving the target patient group’s

needs in an equivalent manner, should be removed for in-house in vitro diagnostic

medical devices.

(13) Laboratories that conduct clinical research in the context of clinical trials of medicinal

products subject to Regulation (EU) No 536/2014 often develop tests in-house to meet

patient needs in clinical trials. Where those tests are not manufactured on an industrial

scale and are not commercialised, the situation of such laboratory-developed tests is

similar to in-house devices manufactured and used within a health institution. The

exemption from certain requirements of Regulation (EU) 2017/746, as provided for in

Article 5(5) of that Regulation, should therefore also apply to laboratory-developed

tests used exclusively for clinical trials.

(14) To ensure a level playing field between devices sold online and those sold via

traditional distribution channels, certain information requirements applicable to

distance sales should be strengthened. In particular, it should be clarified that Member

States may also order, on grounds of public health, the cessation of activity of

providers of diagnostic or therapeutic services by way of information society services,

as defined in Directive (EU) 2015/1535 of the European Parliament and of the

Council12, without prejudice to national law regulating the medical profession.

(15) While it should remain the responsibility of each Member State to determine the

language in which information should be supplied to the users within their territory,

12 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying

down a procedure for the provision of information in the field of technical regulations and of rules on

Information Society services (OJ L 241, 17.9.2015, p. 1, ELI:

http://data.europa.eu/eli/dir/2015/1535/oj).

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Member States should consider accepting such information in other languages of the

Union that are commonly understood in the medical field, especially regarding devices

intended for professional users, in order to reduce costs for translations.

(16) To reduce complexity and enhance consistency, redundant provisions that simply state

that requirements in other provisions within Regulation (EU) 2017/745 or Regulation

(EU) 2017/746, or in other legislation, apply, should be removed.

(17) Some manufacturers have their devices designed and manufactured by another legal or

natural person. Whilst Regulations (EU) 2017/745 and (EU) 2017/746 have increased

transparency regarding the person that designs and manufactures the device, the

responsibilities of the manufacturer regarding its access to the parts of the technical

documentation that may be drawn up by the original equipment supplier should be

clarified, also for the purpose of supervision by competent authorites.

(18) To facilitate and streamline the application of the information obligation in cases of

the interruption or discontinuation of supply of certain devices as laid down in

Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty

regarding the devices that are subject to that information obligation, a central IT tool

for the notification and information sharing should be made available. Moreover, the

EMA should be empowered to draw up and publish a list of devices covered by the

information obligation. The support provided by the EMA in situations of interruption

or discontinuation of supply should also take into account the contribution provided by

the Executive Steering Group on Shortages of Medical Devices (MDSSG) established

by Regulation (EU) 2022/123 of the European Parliament and of the Council13. To

ensure a high level of public health protection, continuous access and availability of

medical devices and in vitro diagnostic medical devices, and to strengthen health

emergency preparedness and response, Member States and the Commission should

have the possibility to request manufacturers of devices, which are included in the list

of devices covered by the information obligation, to provide information regarding

risks and weaknesses within the supply chain that may affect the supply of such

devices. That information can be used for assessing possible vulnerabilities in the

supply chain of critical devices, for example within the framework of the MDSSG.

(19) Having regard to advances in digital communication and digital compliance tools and

in order to reduce administrative burden, it should be specified that communication

between the relevant actors and compliance with legal obligations, including the

drawing up of documentation, reports and other documents as well as conformity

assessment procedures should in principle be possible in digital form. Moreover,

where no specific format is required, digital formats, such as electronic signatures,

should be accepted by default.

13 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a

reinforced role for the European Medicines Agency in crisis preparedness and management for

medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI:

http://data.europa.eu/eli/reg/2022/123/oj).

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(20) To simplify rules and reduce compliance costs, some overly prescriptive requirements,

such as the qualification requirements for the person responsible for regulatory

compliance or the permanent and continuous availability of that person when not part

of the manufacturer’s organisation, should be removed. Also, unnecessary reporting

and certification requirements regarding the repackaging or relabelling of devices that

are already placed and further distributed within the internal market, for example

outside the manufacturer’s official distribution schemes, should be removed.

(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745

highlighted that the application of the rules on single-use devices is fragmented across

the Union and the relevant requirements are complex to implement, resulting in a very

limited and unattractive market for the reprocessing of single-use devices. To simplify

the rules regarding single-use devices and to increase the re-use of devices for

economic and environmental reasons, it should be the responsibility of the

manufacturer to determine whether and how a device can be reprocessed, based on the

device’s characteristics and properties. Unless the indication of single-use is duly

justified by the manufacturer, devices should be subject to reprocessing, whilst single-

use devices or devices which cannot be further reprocessed should be subject to full

refurbishing.

(22) The unique device identification (UDI) system and the registration of devices in the

European database for medical devices (Eudamed) are fundamental tools for ensuring

the traceability and transparency of devices made available on the Union market. To

enhance clarity and legal certainty, the respective provisions related to those tools laid

down in Regulations (EU) 2017/745 and (EU) 2017/746 should be clarified and

streamlined.

(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical

devices can help foster innovation and improve diagnosis and treatment of patients.

The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as

applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the

Council could lead to overlaps of requirements and stifle innovation. To prevent those

overlaps and to simplify the regulatory framework for artificial intelligence-enabled

devices, the application of Regulation (EU) 2024/1689 to those devices should be

limited to those provisions referred to in Article 2(2) of that Regulation. The

references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation

(EU) 2024/1689 should therefore be moved from Section A to Section B. Where

14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the

operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on

single-use devices and their reprocessing (COM(2024)560 final). 15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying

down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No

167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives

2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689,

12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

EN 27 EN

needed, the Commission may use its implementing and delegated powers to lay down

specific requirements regarding artificial intelligence, taking into account the

requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689.

Moreover, notified bodies that are designated to assess high-risk AI systems falling

under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also

the specific AI-related requirements set out in Article 31 of Regulation (EU)

2024/1689.

(24) The summary of safety and clinical performance under Regulation (EU) 2017/745 and

the summary of safety and performance under Regulation (EU) 2017/746 ensure

transparency regarding the clinical evidence on which the safety and performance

assessment of the device is based. As the drawing up and updating of such a summary

is costly, the range of devices subject to that requirement should be clearly limited to

those devices for which a systematic assessment of the device’s technical

documentation is required pursuant to Regulations (EU) 2017/745 and (EU) 2017/746.

Moreover, the summary should be drawn up in a way that is clear for the intended user

of the device. To reduce burden and enhance cost-efficiency, additional versions for

other persons, such as patients, should not be required. Moreover, as the draft

summary is in any case part of the documentation to be submitted to the notified body,

a separate validation of the summary by the notified body should not be required. In

addition, duplication of information to be provided in the summary and in the

instructions for use should be avoided.

(25) In accordance with Regulations (EU) 2017/745 and (EU) 2017/746, notified bodies

exercise a key function in the medical device regulatory system as the issuance of a

certificate by a notified body is a prerequisite for market access of most devices. In

order to ensure that devices benefit from uniform and predictable conditions for

market access, the accountability of notified bodies and the degree of harmonisation of

their conformity assessment activities should therefore be enhanced. For that purpose,

the process for the assessment of applicant notified bodies and their designation should

be streamlined. Moreover, the oversight of notified bodies should be tightened through

the involvement of joint assessment teams also in the monitoring of notified bodies. In

light of such changes, the full reassessment of notified bodies every five years is no

longer required and should therefore be removed.

(26) To streamline the assessment and monitoring of notified bodies, the joint assessment

teams should include the national authority responsible for the notified body as well as

experts from other Member States and experts nominated by the Commission.

Moreover, the national authority responsible for the notified body should be tasked

with deciding on disputes between manufacturers and notified bodies that arise in the

context of conformity assessment procedures.

(27) Even though most notified bodies are private for-profit entities, they exercise their

function in the public interest. With regard to manufacturers that are micro or small

EN 28 EN

enterprises within the meaning of Commission Recommendation 2003/361/EC16 and

with regard to orphan devices, notified bodies should therefore be required to reduce

their fees for conformity assessment activities in accordance with Regulations (EU)

2017/745 and (EU) 2017/746.

(28) To enhance predictability regarding the fees charged by notified bodies for conformity

assessment activities of devices in accordance with Regulations (EU) 2017/745 and

(EU) 2017/746 and to prevent excessively high fees, the Commission should be

empowered to adopt implementing acts to set the level and structure of fees by the

notified bodies, without prejudice to the potential application of Articles 101 and/or

102 of the Treaty on the Functioning of the European Union to the way notified bodies

set their prices or carry out their economic activities.

(29) Devices are classified in different classes depending on their level of risk. Some of the

classification rules should be adapted to reflect the inherent risk of devices, resulting

in a lower risk classification, such as for reusable surgical instruments or accessories

for active implantable devices.

(30) For lower and medium-risk devices, the involvement of notified bodies in the

conformity assessment process should be reduced so that it is proportionate to the risk

class of the device. For example, for class IIa and non-implantable class IIb devices, or

most class C devices, where the notified body is to assess the technical documentation

on a sampling basis, it should be clarified that the technical documentation assessment

is only needed for one representative device of a category of devices or a generic

device group, or in the case of class B devices only for one device from the

manufacturer’s product portfolio. Additional technical documentation assessment

during surveillance activities should only be carried out when potential concerns exist

based on data available from the post-market surveillance system. As class A sterile

devices are of low risk, notified body involvement for those devices should be

removed.

(31) To support innovation and the development and availability of breakthrough

technology and of devices intended for small groups of patients, the conformity

assessment procedures should be adapted to address the specific situation of those

devices. For that purpose, criteria for breakthrough devices and orphan devices should

be included in Regulations (EU) 2017/745 and (EU) 2017/746, based on guidance

developed by the Medical Device Coordination Group. If the status as a breakthrough

device or orphan device is confirmed by an expert panel, the review of the device by

the notified body should be prioritised, if necessary with additional advice from the

expert panels.

(32) The clinical evaluation consultation procedure provided for in Regulation (EU)

2017/745 is a tool to scrutinise the assessment of notified bodies regarding certain

16 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-

sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

EN 29 EN

high-risk devices. The procedure should be focused on devices where that exceptional

scrutiny gives an additional assurance for patient safety. The scope of the clinical

evaluation consultation procedure should therefore be limited to class III implantable

devices, removing from its scope class IIb active devices intended to administer and/or

remove a medicinal product. However, there should be the possibility to add specific

types of high-risk devices to the scope of the clinical evaluation consultation

procedure by way of delegated act, where justified on grounds of patient safety.

(33) The performance evaluation assessment procedure provided for in Regulation (EU)

2017/746 is not effective for certain class D devices as it mixes up the responsibilities

of expert panels and notified bodies. It should therefore be removed and replaced with

an early scientific advice process for high-risk in vitro diagnostic medical devices that

provides for the possibility of manufacturers to seek advice from expert panels on their

performance evaluation strategy.

(34) When the validity of a certificate for medical devices or for in vitro diagnostic medical

devices issued by a notified body expires, notified bodies are to assess whether the

certificate can be renewed. This creates administrative burden, uncertainty and

unnecessary costs. The maximum validity period of certificates issued by notified

bodies should therefore be removed, unless the notified body considers it necessary to

limit the validity on justified grounds, such as in the case of a certificate issued with

conditions where the manufacturer has to collect additional clinical data after

certification in the post-market phase, as may be the case for breakthrough technology

devices.

(35) In order to respond to a public health emergency at Union level recognised in

accordance with Regulation (EU) 2022/2371 of the European Parliament and of the

Council17, or to ensure the supply of medical devices and in vitro diagnostic medical

devices falling under the definition of medical countermeasures within the framework

of Council Regulation (EU) 2022/237218, the Commission should be able to authorise,

by means of implementing acts, the placing on the market or putting into service of

devices for which a conformity assessment in accordance with Regulations (EU)

2017/745 and (EU) 2017/746 has not been carried out. Moreover, where specific CE

marked devices are needed, for example in greater numbers or with an adapted

intended purpose, to respond to a public health emergency or a disaster or crisis,

Member States, or the Commission, should be able to exempt manufacturers from

certain requirements related to the manufacturing, design or intended purpose of the

device.

17 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on

serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022,

p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj). 18 Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the

supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union

level (OJ L 314, 6.12.2024, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj).

EN 30 EN

(36) To ensure that the legal framework governing the highly innovative sectors of medical

devices and in vitro medical devices is future-proof and able to support innovation,

Member States and the Commission should be able to establish regulatory sandboxes

in the field of medical devices or in vitro diagnostic medical devices to facilitate the

development and testing of innovative devices or regulatory approaches under strict

oversight.

(37) Article 4 of Directive 2010/63/EU of the European Parliament and the Council19

prescribes that, wherever possible, a scientifically satisfactory method or testing

strategy, not entailing the use of live animals, shall be used instead of an animal-based

procedure. Non-animal tests such as New Approach Methodologies (NAMs), which

include innovative in-vitro (cell or tissue-based), in-chemico (chemical-based), in-

silico (computer-based) approaches, or combinations of these, can increasingly replace

or complement animal-based tests for safety and performance studies. The use of non-

animal methods, including NAMs, to provide scientific evidence in clinical and non-

clinical studies should therefore be promoted.

(38) As the safety and performance of many devices other than high-risk devices can be

sufficiently demonstrated using non-clinical data, including NAMs, the possibility to

use non-clinical data to confirm the safety and performance of a device in the

conformity assessment should therefore be made more prominent in Regulation (EU)

2017/745.

(39) Clinical data are often available for devices that are equivalent to the device under

conformity assessment. In order to make the conditions under which manufacturers

can claim equivalence more flexible, the requirement in Regulation (EU) 2017/745 for

a contract with the manufacturer of the equivalent device granting access to its

technical documentation should therefore be removed and the equivalence criteria be

adapted.

(40) Post-market clinical follow-up (PMCF) is an important requirement in Regulation

(EU) 2017/745 to identify any safety issues that might appear during real world use of

the device. To reduce the number of reports that manufacturers are required to draw

up, manufacturers should be able to include the findings of the PMCF directly in the

updated clinical evaluation report, without the need to draw up a separate PMCF

evaluation report.

(41) The obligation to prepare a periodic safety update report (PSUR) is an important tool

provided for in Regulations (EU) 2017/745 and (EU) 2017/746 that requires

manufacturers to verify the safety and performance of a device during its lifetime. In

order to avoid unnecessary costs and administrative burden for manufacturers and to

19 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the

protection of animals used for scientific purposes (OJ L 276 20.10.2010, p. 33, ELI:

http://data.europa.eu/eli/dir/2010/63/2019-06-26 ).

EN 31 EN

make the obligation more proportionate, the frequency for updating the PSUR should

be reduced depending on the risk class of the device.

(42) Unnecessary overlaps and duplication of assessments between different actors in the

regulatory system negatively impact the efficiency and consistency of that regulatory

system. Therefore, the roles and responsibilities of competent authorities and notified

bodies, in particular regarding the assessment of vigilance cases, should be clarified

and any unnecessary elements removed.

(43) There is a growing number of clinical studies involving, simultaneously, a clinical trial

of a medicinal product subject to Regulation (EU) No 536/2014 of the European

Parliament and of the Council20, a performance study of an in vitro diagnostic medical

device subject to Regulation (EU) 2017/746 or a clinical investigation of a medical

device subject to Regulation (EU) 2017/745 (‘combined studies’). To address

concerns raised regarding the complexity of applying multiple Regulations to those

combined studies, sponsors should be enabled to submit a single application for a

combined study leading to its coordinated assessment under Regulation (EU) No

536/2014. Regulations (EU) 2017/746 and Regulation (EU) 2017/745 should not be

applicable where a single application has been submitted.

(44) Regulation (EU) 2024/2847 of the European Parliament and of the Council21 requires

manufacturers to notify actively exploited vulnerabilities and severe incidents having

an impact on the security of products with digital elements in order to ensure that the

relevant national computer security incident response teams (CSIRTs) designated as

coordinators, and the European Union Agency for Cybersecurity (ENISA), have an

adequate overview of vulnerabilities and incidents impacting the internal market.

Medical devices and in vitro diagnostic medical devices, however, are exempted from

Regulation (EU) 2024/2847. While cybersecurity related incidents need to be reported

in accordance with existing vigilance rules in Regulations (EU) 2017/745 and (EU)

2017/746 when they qualify as serious incidents, cybersecurity related incidents that

do not concern public health or patient safety, are not reported. This is an important

cybersecurity gap. Manufacturers of connected devices should therefore be obliged to

report also those incidents to the CSIRTs and ENISA through Eudamed.

(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely

manufacturers, competent authorities, notified bodies and the Commission, should

have access to experts with relevant scientific, clinical, technical and regulatory

expertise. Enhanced coordination and access to expertise result in a predictable and

20 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on

clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158,

27.5.2014, p.1, ELI; http://data.europa.eu/eli/reg/2014/536/oj). 21 Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on

horizontal cybersecurity requirements for products with digital elements and amending Regulations

(EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L

2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj).

EN 32 EN

reliable regulatory framework. The type of expertise available in the expert panels

range of areas in which expert panels provide advice and their involvement in the

regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should

therefore be expanded. The mandate of the EMA to support the expert panels in

accordance with Regulation (EU) 2022/123 should be amended accordingly.

(46) Regulations (EU) 2017/745 and (EU) 2017/746 provide for a decentralised regulatory

system. Effective coordination between national authorities is essential to ensure the

smooth functioning of the internal market and a coherent application of the

requirements laid down in the Regulations to ensure a uniform high level of protection

of patient safety and public health. For an effective and efficient coordination, national

authorities need scientific, technical and administrative support, which can be

provided in the most adequate way by the EMA, as it already manages the medical

device expert panels. The EMA should therefore be mandated to provide, on behalf of

the Commission, the necessary support for the coordination between national

competent authorities to facilitate uniform application of Regulations (EU) 2017/745

and (EU) 2017/746 .

(47) The Union participates in the International Medical Device Regulators Forum

(IMDRF)22, which is a voluntary group of regulators from around the world that aims

to accelerate international regulatory harmonisation and convergence in the field of

medical devices and in vitro diagnostic medical devices. To a large extent, the Union

regulatory system for medical devices reflects guidelines developed in the framework

of the IMDRF. To increase efficiency, reduce duplication of regulatory efforts and

promote global convergence, the Commission and Member States should actively

participate in, and make use of, international regulatory cooperation and reliance

mechanisms or reliance programmes.

(48) To avoid the risk of misunderstanding regarding kits that are in vitro diagnostic

medical devices and that integrate products which are subject to other Union

legislation, such as medicinal products, it should be clarified that products which are

included in kits should be in conformity with the legislation applicable to those

products.

(49) Regulation (EU) 2017/746 introduced specific provisions for companion diagnostics.

In light of the experience gained from the application of those provisions, it is

necessary to clarify in the definition of companion diagnostics that a companion

diagnostic may be linked to more than one medicinal product. Moreover, to avoid any

unnecessary duplication in the assessment of companion diagnostics, it should be

clarified that the consultation of a medicinal products authority should only be

necessary regarding novel companion diagnostics and that a consulted medicinal

products authority should not repeat the assessment carried out by a notified body.

22 International Medical Device Regulators Forum (IMDRF) | International Medical Device Regulators

Forum

EN 33 EN

(50) Performance studies are an important source of clinical evidence for in vitro diagnostic

medical devices. The rules applicable to the conduct of performance studies should be

simplified in cases where they do not present any additional risks to the subjects of the

study, such as in cases where the study involves routine blood draws from non-

vulnerable individuals or where studies on companion diagnostics are conducted using

left-over samples.

(51) The transition from the previous regulatory framework to that under Regulations (EU)

2017/745 and (EU) 2017/746 has led to the discontinuation of certain devices intended

for small groups of patients, as the costs for the transition made it economically

difficult for manufacturers to undertake conformity assessment in accordance with

those Regulations. The discontinuation of those orphan devices jeopardises the level of

care and patient protection, where no alternative diagnosis or treatment methods are

available. Manufacturers should therefore be allowed, subject to certain conditions, to

continue marketing orphan devices that were lawfully marketed in accordance with the

Directives 90/385/EEC, 93/42/EEC and 98/79/EC without the need to conduct a

conformity assessment procedure pursuant to Regulations (EU) 2017/745 and (EU)

2017/746.

(52) Certain Annexes to Regulations (EU) 2017/745 and (EU) 2017/746, which further

specify the obligations and requirements applicable to notified bodies, economic

operators and devices, should be aligned with the changes made in the corresponding

provisions of those Regulations and to reflect the same objectives, namely

simplification, burden reduction, enhanced cost-efficiency of the certification process

and further digitalisation.

(53) To reduce costs and length of conformity assessment procedures for medical devices

that integrate a medicinal substance or a SoHO, the consultation of the medicinal

products authorities or the SoHO authorities should be streamlined and shortened.

Substance-based medical devices that are systematically absorbed by the human body

are medical devices. They do not incorporate any substance that, if used separately,

would fall under Union legislation on medicinal products. The consultation of a

medicinal products authority in the framework of the conformity assessment of such

substance-based medical devices is not appropriate and should therefore be removed.

(54) Regulations (EU) 2017/745 and (EU) 2017/746 delegated to the Commission the

power to adopt delegated acts in accordance with Article 290 TFEU in order to amend

certain non-essential provisions in Regulations (EU) 2017/745 and (EU) 2017/746.

Having regard to the experience with the application of those Regulations and the

necessity to maintain a level of flexibility regarding the often very technical and

procedural requirements in the Regulations, the power to adopt delegated acts should

be provided also for other non-essential provisions in Regulations (EU) 2017/745 and

(EU) 2017/746, to adapt them to experience gained from their application, scientific or

technical progress or developments at international level.

(55) Regulations (EU) 2017/745 and (EU) 2017/746 conferred on the Commission the

power to adopt implementing acts. In order to ensure uniform conditions of

implementation of those Regulations additional implementing powers should be

conferred on the Commission.

(56) Since the objectives of this Regulation, namely simplification and burden reduction of

the rules on medical devices and on in vitro diagnostic medical devices, while

preserving the objectives of Regulations (EU) 2017/745 and (EU) 2017/746 as such,

cannot be sufficiently achieved by the Member States but can rather, by reason of the

EN 34 EN

scale or effects of the action, be better achieved at Union level, the Union may adopt

measures, in accordance with the principle of subsidiarity as set out in Article 5 of the

Treaty on European Union. In accordance with the principle of proportionality as set

out in that Article, this Regulation does not go beyond what is necessary in order to

achieve those objectives.

(57) Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be amended

accordingly.

(58) In order to allow all affected parties sufficient time to take the necessary measures to

comply with this Regulation, the application of certain provisions should be deferred.

However, provisions that do not require time for preparation should be applicable

from the date of the entry into force of this Regulation.

(59) This Regulation introduces binding requirements for cross-border digital public

services within the meaning of Regulation (EU) 2024/903 of the European Parliament

and of the Council23. An interoperability assessment has therefore been completed.

The Digital Dimensions chapter of the Legislative Financial and Digital Statement

constitutes the resulting report,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EU) 2017/745

Regulation (EU) 2017/745 is amended as follows:

(1) Article 1 is amended as follows:

(a) in paragraph 2, the first sentence is replaced by the following:

‘This Regulation shall also apply, as from the date of application of common

specifications adopted pursuant to Article 9, to the groups of products without

an intended medical purpose that are listed in Annex XVI, and their

accessories, taking into account the state of the art, and in particular existing

harmonised standards for analogous devices with a medical purpose, based on

similar technology.’;

(b) paragraph 4 is replaced by the following:

‘4. For the purposes of this Regulation, medical devices, accessories for

medical devices, and products listed in Annex XVI and their accessories,

to which this Regulation applies pursuant to paragraph 2 shall hereinafter

be referred to as ‘devices’.’;

23 Regulation (EU) 2024/903 of the European Parliament and of the Council of 13 March 2024 laying

down measures for a high level of public sector interoperability across the Union (Interoperable Europe

Act) (OJ L 2024/903, 22.3.2024, ELI: http://data.europa.eu/eli/reg/2024/903/oj).

EN 35 EN

(c) in paragraph 6, point (g) is replaced by the following:

‘(g) organs intended for transplantation falling within the scope of Directive

2010/53/EU of the European Parliament and of the Council* or

substances of human origin falling within the scope of Regulation (EU)

2024/1938 of the European Parliament and of the Council**, or their

derivatives, or products containing or consisting of them; however, this

Regulation does apply to devices manufactured utilising derivatives of

substances of human origin which are non-viable or are rendered non-

viable;

______________________

* Regulation (EU) 2024/1938 of the European Parliament and of the

Council of 13 June 2024 on standards of quality and safety for substances

of human origin intended for human application and repealing Directives

2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI:

http://data.europa.eu/eli/reg/2024/1938/oj).

** Directive 2010/53/EU of the European Parliament and of the Council of

7 July 2010 on standards of quality and safety of human organs intended

for transplantation (OJ L 207, 6.8.2010, p. 14, ELI:

http://data.europa.eu/eli/dir/2010/53/oj).’;

(d) paragraph 7 is replaced by the following:

‘7. Any device which, when placed on the market or put into service,

incorporates as an integral part an in vitro diagnostic medical device as

defined in Article 2, point (2), of Regulation (EU) 2017/746 that has an

action ancillary to that of the device in which it is incorporated, shall be

governed by this Regulation. In that case, the relevant general safety and

performance requirements set out in Annex I to

Regulation (EU) 2017/746 shall apply with regard to the safety and

performance of the in vitro diagnostic medical device part.

However, if the action of the in vitro diagnostic medical device is

principal and not ancillary to that of the device in which it is

incorporated, the integral product shall be governed by Regulation (EU)

2017/746. In that case, the relevant general safety and performance

requirements set out in Annex I to this Regulation shall apply with regard

to the safety and performance of the device part.’;

(e) paragraph 10 is amended as follows:

(i) the first subparagraph is replaced by the following:

‘Any device which, when placed on the market or put into service,

incorporates, as an integral part, non-viable substances of human

origin or their derivatives that have an action ancillary to that of the

device in which they are incorporated shall be assessed and

authorised in accordance with this Regulation.’;

(ii) in the second subparagraph, first sentence, the reference to ‘Directive

2004/23/EC’ is replaced by a reference to ‘Regulation (EU) 2024/1938’;

(2) Article 2 is amended as follows:

(a) in point (1), the second subparagraph is replaced by the following:

EN 36 EN

‘The following products shall also be deemed to be medical devices:

– devices for the control or support of conception;

– products specifically intended for the cleaning, disinfection or

sterilisation of devices as referred to in Article 1(4).’;

(b) point (7) is replaced by the following:

‘(7) ‘generic device group’ means a set of devices having the same or similar

intended purposes and a commonality of technology allowing them to be

classified in a generic manner not reflecting specific characteristics;’;

(c) points (18), (19), (20) and (21) are deleted;

(d) point (48) is replaced by the following:

‘(48) ‘clinical data’ means information concerning safety or performance that

is generated from the use of a device and is sourced from any of the

following:

– clinical investigations of the device concerned or of a device for

which equivalence to the device concerned can be demonstrated;

– other studies published in scientific literature on the device

concerned or of a device for which equivalence to the device

concerned can be demonstrated;

– other clinical experience published in peer-reviewed scientific

literature with the device concerned or a device for which

equivalence to the device concerned can be demonstrated;

– clinically relevant information coming from post-market

surveillance, in particular the post-market clinical follow-up;’;

(e) the following points (72), (73), (74), (75) and (76) are added:

‘(72) ‘well-established technology device’ means a device that belongs to a

generic device group, which fulfils the following criteria:

(a) it has simple, common and stable design;

(b) it has not been associated with safety issues in the past;

(c) it has well-known clinical performance characteristics and

comprises standard of care devices with little evolution in

indications and the state of the art;

(d) it has a long history on the Union market;’;

(73) ‘combined study’ means a clinical trial, as defined in Article 2(2), point

(2), of Regulation (EU) No 536/2014, of one or more medicinal products,

combined with a performance study of one or more in vitro diagnostic

medical devices as defined in Article 2, point (42), of Regulation (EU)

2017/746, and/or with a clinical investigation of one or more devices;

(74) ‘regulatory sandbox’ means a controlled environment set up by

a competent authority which offers manufacturers or prospective

manufacturers the possibility to develop, test, validate and use, where

appropriate in real-world conditions, an innovative product or technology

EN 37 EN

potentially falling within the scope of this Regulation, pursuant to

a sandbox plan for a limited time under regulatory supervision;

(75) ‘sandbox plan’ means a document agreed between the participating

manufacturer(s) or prospective manufacturer(s) and the competent

authority describing the objectives, conditions, timeframe, methodology

and requirements for the activities carried out within the regulatory

sandbox;

(76) ‘Union regulatory sandbox’ means a controlled environment set up by

the Commission for testing alternative or new regulatory requirements or

enforcement practices and appraising their validity in comparison with

existing requirements and practices under this Regulation for a limited

time.’;

(3) Articles 3 and 4 are replaced by the following:

‘Article 3

Amendment and implementation of certain definitions

1. The Commission is empowered to adopt delegated acts in accordance with

Article 115 in order to amend the definition of well-established technology

device set out in Article 2, point (72), in the light of technical and scientific

progress and taking into account definitions agreed at Union and international

level.

2. The Commission may, by means of implementing acts, draw up non-

exhaustive lists of devices that fall under, or of devices that do not fall under

the definition of well-established technology device in Article 2, point (72).

Those implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 114(3).

Article 4

Regulatory status of products

1. The competent authorities of the Member States shall coordinate their activities

when determining whether a specific product, or category, or group of

products, falls within the definition of ‘medical device’ set out in Article 2,

point (1), or the definition of ‘accessory for a medical device’ set out in Article

2, point (2), or whether a product falls within the scope of Annex XVI or is an

accessory for a product listed in that Annex.

2. The Member States shall ensure an appropriate level of consultation of the

relevant competent authorities of the Member States in the fields of in vitro

diagnostic medical devices, medicinal products, substances of human origin

(SoHO), biocides, food products, cosmetics or other products subject to Union

legislation, where the determination of whether a product has the regulatory

status of a device involves aspects concerning the borderline with any of those

types of products. If that is the case, Member States shall also ensure an

appropriate level of consultation of the relevant advisory or regulatory bodies

established in the relevant Union legislation, such as the European Medicines

Agency (EMA), the SoHO Coordination Board, the European Chemicals

Agency (ECHA) and the European Food Safety Authority (EFSA).

EN 38 EN

3. Where a competent authority of a Member State, after having performed an

evaluation in accordance with Article 94, considers that a product that is CE

marked in accordance with Article 20, does not fall within the scope of this

Regulation, it shall consult the competent authorities of the other Member

States regarding its envisaged measure determining the regulatory status of the

product in question.

4. Where a competent authority of a Member State raises a substantiated

disagreement regarding the envisaged measure referred to in paragraph 3, the

consulting authority shall refer the matter to an expert panel as referred to in

Article 106 and give utmost consideration to the opinion of that expert panel.

5. The results of the coordination activities of the competent authorities in

accordance with this Article and the opinions of the expert panel delivered in

accordance with paragraph 4 of this Article and Article 4a(2) shall be made

publicly available, without disclosing any confidential information as referred

to in Article 109.

6. The Commission may, by means of implementing acts, lay down the

procedure, including timelines, for the application of paragraphs 1 to 4 of this

Article and of Article 4a. Those implementing acts shall be adopted in

accordance with the examination procedure referred to in Article 114(3).’;

(4) the following Article 4a is inserted:

‘Article 4a

Opinion on and

determination of the regulatory status of a product

1. A competent authority, a notified body, a manufacturer, a developer of a

product or the Commission may submit a substantiated request for an opinion

from an expert panel referred to in Article 106 on the question whether a

specific product, or category or group of products, falls within the definitions

of ‘medical device’ or ‘accessory for a medical device’, or whether a product

falls within the scope of Annex XVI or is an accessory for a product listed in

that Annex. Where, in such a request, the requester considers that the product

in question is a device, the request shall also specify the proposed classification

of the device in accordance with Article 51 and Annex VIII.

2. The expert panel shall provide its opinion without undue delay. The requester

shall give utmost consideration to the opinion of the expert panel.

3. Having regard to the expert panel opinion referred to in paragraph 2 or in

Article 4(4), a Member State may submit a substantiated request to the

Commission to determine whether a specific product, or category or group of

products, falls within the definitions of ‘medical device’ or ‘accessory for a

medical device’, or whether a product falls within the scope of Annex XVI or

is an accessory for a product listed in that Annex.

The Commission shall decide on the substantiated request of the Member State

or on its own initiative, by means of implementing acts, which shall be adopted

in accordance with the examination procedure referred to in Article 114(3).

The Commission may ask the expert panel for clarifications or refer the

opinion back to the expert panel for further consideration, including in cases

EN 39 EN

where a Member State’s substantiated request raises new questions of a

scientific or technical nature.

4. This Article shall not apply where within the framework of another Union

legislation the regulatory status of the product, or category or group of products

concerned has been determined as falling within the scope of that other Union

legislation, or where a procedure for the determination of the regulatory status

is ongoing within the framework of another Union legislation.’;

(5) Article 5 is amended as follows:

(a) paragraph 5 is amended as follows:

(i) the first subparagraph is amended as follows:

(1) point (a) is replaced by the following:

‘(a) the devices are not transferred to another legal entity, except

to another health institution in the duly justified interest of

public health, patient safety or patient health, or to prepare or

respond to a public health emergency;’;

(2) point (d) is replaced by the following:

‘(d) upon request by a competent authority, the health institution

provides information upon request on the use of such devices,

which includes the justification referred to in points (a) and

(c);’;

(3) point (f) is replaced by the following:

‘(f) the health institution draws up documentation that is

sufficiently detailed to enable the competent authority to

ascertain that the relevant general safety and performance

requirements set out in Annex I are met;’;

(4) point (g) is deleted;

(ii) the second subparagraph is replaced by the following:

‘Member States shall retain the right to restrict the manufacture or the

use of any specific type of such devices and shall be permitted access to

inspect the activities of the health institutions.’;

(iii) The following three subparagraphs are added:

‘For the purposes of the first subparagraph, point (a), in the case of a

transfer of the device to another health institution, the transferring and

receiving health institutions shall ensure traceability of the device.

For the purposes of the first subparagraph, point (c), from the date that

the health institution becomes aware that the target patient group's

specific needs can be met by a device available on the market, it may

continue to manufacture and use its device for a maximum period of 10

years.

For the purposes of the first subparagraph, point (h), where the device is

transferred in accordance with point (a), the receiving health institution

shall report any incident related to the device to the transferring health

institution.’;

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(b) the following paragraphs 7 and 8 are added:

‘7. The Commission is empowered to adopt delegated acts in accordance

with Article 115 to amend the general safety and performance

requirements set out in Annex I in order to adapt them to scientific or

technical progress or to international developments or to add

requirements in relation to emerging risks or technologies.

8. When adopting implementing acts pursuant to paragraph 6 of this Article,

delegated acts pursuant to paragraph 7 of this Article or Common

Specifications pursuant to Article 9 of this Regulation concerning devices

that are high-risk AI systems as referred to in Article 6(1) of Regulation

(EU) 2024/1689 of the European Parliament and of the Council***, or

that use high-risk AI systems as safety components, the Commission

shall take into account the requirements set out in Chapter III, Section 2,

of that Regulation.

__________________

*** Regulation (EU) 2024/1689 of the European Parliament and of the Council

of 13 June 2024 laying down harmonised rules on artificial intelligence

and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU)

No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and

Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial

Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI:

http://data.europa.eu/eli/reg/2024/1689/oj).’;

(6) Article 6 is amended as follows:

(a) the following paragraph 2a is inserted:

‘2a. Any natural or legal person offering a device in accordance with

paragraph 1 or a service in accordance with paragraph 2 shall provide in

the offer at least the information referred to in Annex I, Section 23.2,

points (a) to (d) and (m), and access to the instructions for use.’;

(b) paragraphs 3 and 4 are replaced by the following:

‘3. Upon request by a competent authority, any natural or legal person

offering a device in accordance with paragraph 1 or a service in

accordance with paragraph 2 shall make available a copy of the

EU declaration of conformity drawn up in accordance with Article 19 or

the statement drawn up in accordance with Article 21(2) for the device

concerned and cooperate with the competent authorities of the Member

State where the device or the service is offered.

4. A Member State may, on grounds of protection of public health, require a

provider of a service as defined in Article 1(1), point (b), of

Directive (EU) 2015/1535, or a provider of a service in accordance with

paragraph 2, to cease its activity.’;

(7) in Article 7, the following subparagraph is added:

‘Without prejudice to national law regarding the exercise of the medical profession,

the first subparagraph shall also apply to devices used for the provision of a service

referred to in Article 6(2).’;

(8) in Article 9(1), the first sentence is replaced by the following:

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‘Where no harmonised standards exist or where relevant harmonised standards are

not sufficient, or where there is a need to address public health concerns, the

Commission, after having consulted the MDCG, may, by means of implementing

acts, adopt common specifications (CS) in respect of the requirements set out in this

Regulation, in particular the reports and plans to be drawn up by manufacturers,

the general safety and performance requirements set out in Annex I, the technical

documentation set out in Annexes II and III, the conformity assessment procedures

set out in Annexes IX to XI and the procedure for custom-made devices set out in

Annex XIII, the clinical evaluation and post-market clinical follow-up set out in

Annex XIV or the requirements regarding clinical investigation set out in

Annex XV.’;

(9) Article 10 is amended as follows:

(a) paragraphs 3 and 7 are deleted;

(b) paragraph 9 is replaced by the following:

‘9. Manufacturers shall put in place an appropriate quality management

system to ensure that procedures are in place to keep series production in

conformity with the requirements of this Regulation. Changes in device

design or characteristics and changes in the harmonised standards or CS

by reference to which the conformity of a device is declared shall be

adequately taken into account in a timely manner. Manufacturers of

devices, other than investigational devices, shall establish, document,

implement, maintain, keep up to date and continually improve a quality

management system that shall ensure compliance with this Regulation in

the most effective manner and in a manner that is proportionate to the

risk class and the type of device.

The quality management system shall cover all parts and elements of a

manufacturer's organisation dealing with the quality of processes,

procedures and devices. It shall govern the structure, responsibilities,

procedures, processes and management resources required to implement

the principles and actions necessary to achieve compliance with the

provisions of this Regulation.’;

(c) paragraph 10 is deleted;

(d) in paragraph 11, the following subparagraph is added:

‘When determining the official language of the Union in which the information

set out in Section 23 of Annex I or other information to be provided by the

manufacturer shall be made available, Member States shall consider accepting

another official language of the Union in which the information is made

available, taking into consideration the technical knowledge, experience,

education or training of the average intended user(s).’;

(e) paragraph 13 is deleted;

(f) paragraph 14 is amended as follows:

(i) the third subparagraph is deleted;

(ii) the fourth subparagraph is deleted;

(g) paragraph 15 is replaced by the following:

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‘15. Where manufacturers have their devices designed and manufactured by

another legal or natural person, the information on the identity of that

person shall be part of the information to be submitted in accordance

with Article 29(4). In those cases, the manufacturer shall ensure that the

relevant parts of the technical documentation are drawn up, kept up to

date and, upon request, made available to the competent authorities in

accordance with paragraphs 4 and 8 of this Article by the legal or natural

person that has designed and manufactured the device. In addition, the

manufacturer shall draw up, keep up to date and, upon request, make

available to the competent authorities the remaining parts of the technical

documentation, in particular those referred to in Section 2 of Annex II

and in Annex III.’;

(h) paragraph 16 is deleted;

(10) Article 10a is amended as follows:

(a) in paragraph 1, the second subparagraph is replaced by the following:

‘The information referred to in the first subparagraph shall be provided at least

six months before the anticipated interruption or discontinuation or, if this is

not possible, without undue delay after the manufacturer becomes aware of the

anticipated interruption or discontinuation. The manufacturer shall specify the

reasons for the interruption or discontinuation in the information provided to

the competent authority.’;

(b) the following paragraphs 4, 5 and 6 are added:

‘4. The Commission, where needed in cooperation with the EMA, shall set

up, maintain, and manage an IT system to facilitate the reporting and

information exchange regarding cases of interruption or discontinuation

of the supply of devices in accordance with paragraphs 1, 2 and 3. That

IT system shall be integrated in or interoperable with the European

database on medical devices referred to in Article 33. It shall also enable

health institutions and healthcare professionals to inform competent

authorities about the unavailability or the immediate risk of unavailability

of devices needed for the exercise of their professional activity.

5. The EMA, in collaboration with the Executive Steering Group on

Shortages of Medical Devices (MDSSG) established by Article 21 of

Regulation (EU) 2022/123, shall develop a methodology to identify the

devices, or categories of devices, for which it is reasonably foreseeable

that an interruption or discontinuation of supply could result in serious

harm or a risk of serious harm to patients or public health as referred to in

paragraph 1. Based on that methodology, the EMA, in collaboration with

the MDSSG and in agreement with the Commission, shall draw up,

publish and keep up to date a list of devices, or categories of devices, to

which paragraphs 1, 2 and 3 shall apply. For the purpose of this

paragraph, the MDCG, representatives of manufacturers, other relevant

actors in the supply chain for the medical device sector and

representatives of healthcare professionals, of patients and of consumers

may be consulted as necessary.

6. The competent authorities of the Member States or the Commission may

request the manufacturers of devices included in the list drawn up in

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accordance with paragraph 5 to provide all necessary information

regarding risks and weaknesses within the supply chain which may affect

the supply of such devices, including production capacity and volume of

sales.’;

(11) in Article 11, paragraphs 4 and 5 are deleted;

(12) in Article 14, paragraph 2 is amended as follows:

(a) in the first subparagraph, point (d) is replaced by the following:

‘(d) that, where applicable, a UDI has been assigned by the manufacturer in

accordance with Article 27(3).’;

(b) the second subparagraph is replaced by the following:

‘In order to meet the requirements referred to in the first subparagraph, the

distributor may apply a sampling method that is representative of the devices

supplied by that distributor.’;

(13) Article 15 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. Manufacturers shall have available within their organisation at least one

person responsible for regulatory compliance who possesses the requisite

expertise in the field of medical devices.’;

(b) paragraph 2 is replaced by the following:

‘2. Micro and small enterprises within the meaning of Commission

Recommendation 2003/361/EC**** shall not be required to have the

person responsible for regulatory compliance within their organisation

but shall have such person at their disposal.

__________________

****Commission Recommendation of 6 May 2003 concerning the definition

of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p.

36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).’;

(c) in paragraph 3, point (c) is replaced by the following:

‘(c) the post-market surveillance obligations are complied with in accordance

with Article 83;’;

(d) paragraph 6 is replaced by the following:

‘6. Authorised representatives shall have permanently and continuously at

their disposal at least one person responsible for regulatory compliance

who possesses the requisite expertise regarding the regulatory

requirements or medical devices in the Union.’;

(14) Article 16 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) in the first subparagraph, the introductory wording is replaced by the

following:

EN 44 EN

‘A distributor, an importer or another natural or legal person who places

a product on the market or puts it into service shall assume the

obligations incumbent on manufacturers if it does any of the following:’;

(ii) the second subparagraph is replaced by the following:

‘The first subparagraph shall not apply to any healthcare professional or

any other person who, while not considered a manufacturer, assembles or

adapts for an individual patient a device already on the market without

changing its intended purpose.’;

(b) paragraph 4 is deleted;

(15) Article 17 is replaced by the following:

‘Article 17

Single-use devices and reprocessing of devices that are not for single use

1. A device shall only be intended for single-use where the manufacturer, in light

of the design, construction, material, chemical, physical and biological

properties of the device, cannot ensure that the device continues to meet the

relevant safety and performance requirements when reused in accordance with

its intended purpose after appropriate reprocessing. The manufacturer’s

justification of an indication of single use shall be part of the technical

documentation referred to in Annex II.

2. If the device is not intended for single-use, the manufacturer shall provide

information about the appropriate reprocessing process for allowing reuse in

the instructions for use in accordance with Annex I, Section 23.4, point (n).

3. Single-use devices and devices that cannot be further reprocessed may be

subject to full refurbishing within the meaning of Article 2(31). The natural or

legal person that carries out the full refurbishing shall be considered as the

manufacturer of the fully refurbished device.

4. The Commission may adopt, in accordance with Article 9(1), CS on general

requirements regarding reprocessing of devices or fully refurbishing of single-

use devices.’;

(16) Article 18 is amended as follows:

(a) in paragraph 1, second subparagraph, the first sentence is replaced by the

following:

‘The information referred to in the first subparagraph shall be provided, for the

purpose of making it available to the patient who has been implanted with the

device, by any means, including in electronic or digital format, that allow rapid

access to that information and shall be stated in the language(s) determined by

the concerned Member State.’;

(b) paragraph 3 is replaced by the following:

‘3. Implants that are well-established technology devices shall be exempted

from the obligations laid down in this Article’;

(17) in Article 19, the following paragraph 2a is inserted:

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‘2a. Declarations of conformity in accordance with paragraphs 1 and 2 may be

provided in electronic form.’;

(18) in Article 22, paragraph 2 is replaced by the following:

‘2. The statement made pursuant to paragraph 1 shall contain at least the following

information:

(a) an identification of the devices and, where applicable, other products

included in the system or procedure pack, including where applicable

their Basic UDI-DI;

(b) where applicable, an identification of the notified body involved in the

sterilisation activities referred to in paragraph 3;

(c) a declaration by the natural or legal person that:

(i) they have verified the mutual compatibility of the devices and, if

applicable, other products in accordance with the manufacturers'

instructions and have carried out their activities in accordance with

those instructions;

(ii) they have packaged the system or procedure pack and supplied

relevant information to users incorporating the information to be

supplied by the manufacturers of the devices or other products

which have been put together;

(iii) the activity of combining devices and, if applicable, other products

as a system or procedure pack was subject to appropriate methods

of internal monitoring, verification and validation.’;

(19) Article 27 is amended as follows:

(a) in paragraph 1, after point (b) the following point (ba) is inserted:

‘(ba) a Basic UDI-DI, as defined in Part C of Annex VI;’;

(b) paragraph 2 is amended as follows:

(i) point (d) is replaced by the following:

‘(d) the entity gives access to its system for the assignment of UDIs to

all interested users in accordance with a set of predetermined and

transparent terms and conditions that take into account the interests

of micro, small and medium-sized enterprises within the meaning

of Recommendation 2003/361/EC;’;

(ii) in point (e), the following point (iv) is added:

‘(iv) offer its system for the assignment of UDIs to manufacturers that

are micro and small enterprises within the meaning of

Recommendation 2003/361/EC under preferential conditions that

take into account the specific needs of such enterprises and are

proportionate to their size.’;

(c) paragraph 3 is replaced by the following:

‘3. Before placing a device, other than a custom-made device or

investigational device, on the market, the manufacturer shall, in

accordance with the rules of the issuing entity designated by the

Commission in accordance with paragraph 2, assign to the device a Basic

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UDI-DI and a UDI as defined in Part C of Annex VI. If applicable, the

manufacturer shall assign a UDI-DI to all higher levels of packaging.’;

(d) the following paragraphs 3a and 3b are inserted:

‘3a. Before placing on the market a system or procedure pack pursuant to

Article 22(1) and (3), the natural or legal person responsible shall assign

to the system or procedure pack, in accordance with the rules of the

issuing entity designated by the Commission in accordance with

paragraph 2, a Basic UDI-DI and UDI as defined in Part C of Annex VI.

3b. For devices that are the subject of a conformity assessment as referred to

in Article 52(3) and in Article 52(4), second and third subparagraphs, a

Basic UDI-DI referred to in paragraph 1 of this Article shall be assigned

before the manufacturer applies to a notified body for that assessment.’;

(e) in paragraph 10, points (a) and (b) are replaced by the following:

‘(a) amending the list of information set out in Parts A and B of Annex VI in

the light of technical progress;

(b) amending Annex VI in the light of experience obtained from the

implementation of the UDI system, or in the light of international

developments and technical progress in the field of Unique Device

Identification.’;

(f) in paragraph 11, the following point (c) is added:

‘(c) determining the UDI related obligations laid down in this Article, Article

29 and Annex VI Part C that shall not apply to certain devices, categories

or groups of devices in view of the highly individualised characterisation

of those devices, or in view of their risk class, the number of devices

placed on the market and the financial and administrative burden related

to the assignment of UDI.’.

(20) Article 28 is amended as follows:

(a) paragraph 3, is replaced by the following:

‘3. The core data elements to be provided to the UDI database, referred to in

Part B of Annex VI, shall be accessible to the public, except the element

referred to in point 13 of that Part.’.

(21) Article 29 is replaced by the following:

‘Article 29

Registration of devices and systems or procedure packs

1. Before placing a device, other than a custom-made device or investigational

device, on the market, the manufacturer shall provide the Basic UDI-DI to the

UDI database together with the other core data elements referred to in Part B of

Annex VI related to that device, as applicable. The manufacturer shall keep the

information provided to the UDI database updated.

2. Before placing on the market a system or procedure pack as referred to in

Article 22(1) and (3), the natural or legal person responsible shall provide the

Basic UDI-DI to the UDI database together with the other core data elements

referred to in Part B of Annex VI related to that system or procedure pack. The

EN 47 EN

natural or legal person referred to in Article 22(1) shall keep up to date the

information provided to the UDI database.

3. For devices that are the subject of a conformity assessment as referred to in

Article 52(3) and in Article 52(4), second and third subparagraphs, the notified

body shall confirm in Eudamed that the information referred to in Part B of

Annex VI is correct.’;

(22) Article 30 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. The Commission, after consulting the MDCG, shall set up and manage

an electronic system to create the single registration number referred to in

Article 31(2) and to collate and process information that is necessary and

proportionate to identify the manufacturer and, where applicable, the

authorised representative, the importer and the person referred to in

Article 22(1). The details regarding the information to be provided to that

electronic system by the economic operators are laid down in Part A,

Section 1, of Annex VI.’;

(b) in paragraph 2, the following sentence is added:

‘Where national distributor databases require information on devices, such

databases shall allow for the retrieval of the device information from the

electronic systems referred to in Article 33(2), points (a) and (b).’;

(23) Article 31 is amended as follows:

(a) the title is replaced by the following:

‘Registration of economic operators’;

(b) paragraphs 1 and 2 are replaced by the following:

‘1. Before placing a device, other than a custom-made device, on the market,

manufacturers, authorised representatives, importers and persons referred

to in Article 22(1) of this Regulation shall, in order to register, submit to

the electronic system referred to in Article 30 the information referred to

in Part A of Annex VI, provided that they have not already registered in

accordance with this Article. In cases where the conformity assessment

procedure requires the involvement of a notified body pursuant to Article

52, the information referred to in Part A of Annex VI shall be provided to

that electronic system before applying to the notified body.

2. Without undue delay, the competent authority shall verify the data

entered pursuant to paragraph 1, obtain a single registration number

(‘SRN’) from the electronic system referred to in Article 30 and issue it

to the manufacturer, the authorised representative, the importer or the

person referred to in Article 22(1).’;

(c) in paragraph 4, the words ‘one week’ are replaced by the words ‘two weeks’;

(d) paragraph 6 is deleted;

(e) paragraph 7 is replaced by the following:

‘7. The data entered pursuant to paragraph 1 of this Article in the electronic

system referred to in Article 30 shall be accessible to the public, except

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the information regarding the person responsible for regulatory

compliance referred to in Part A, point 1.4, of Annex VI.’;

(f) paragraph 8 is replaced by the following:

‘8. The competent authority may use the data to charge the manufacturer, the

authorised representative, the importer or the person referred to in Article

22(1) a fee pursuant to Article 111.’;

(24) Article 32 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. For class IIb implantable devices and for class III devices, other than

custom-made or investigational devices and well-established technology

devices, the manufacturer shall draw up a summary of safety and clinical

performance.

The summary of safety and clinical performance shall be written in a way

that is clear to the intended user and shall be made available to the public

via Eudamed.

The draft of the summary of safety and clinical performance shall be part

of the documentation to be submitted to the notified body involved in the

conformity assessment pursuant to Article 52. The manufacturer shall

ensure that the summary of safety and clinical performance is available in

Eudamed as part of the information on the device to be provided pursuant

to Article 29(1) and mention on the label or instructions for use where

that summary is available.’;

(b) in paragraph 2, point (h) is replaced by the following:

‘(h) information on any residual risks or undesirable effects, and any

warnings and precautions.’;

(25) Article 33 is amended as follows:

(a) in paragraph 2, the following subparagraph is inserted:

‘By way of derogation from the first subparagraph, the Commission may

decide that one or more of the electronic systems referred to in that

subparagraph are not to be included in Eudamed. In that case, the Commission

shall ensure that those electronic systems are interoperable with Eudamed.’;

(b) paragraph 3 is replaced by the following:

‘3. When designing Eudamed and, where applicable, any of the electronic

systems that are not included in Eudamed, the Commission shall give due

consideration to compatibility with national databases and national web-

interfaces to allow for import and export of data.’;

(c) paragraph 4 is replaced by the following:

‘4. The data shall be entered into Eudamed and, where applicable, any of the

electronic systems that are not included in Eudamed by the Member

States, notified bodies, economic operators and sponsors as specified in

the provisions on the electronic systems referred to in paragraph 2. The

Commission shall provide for technical and administrative support to

users of Eudamed and, where applicable, any of the electronic systems

that are not included in Eudamed.’;

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(d) paragraph 5 is replaced by the following:

‘5. All the information collated and processed by Eudamed and, where

applicable, any of the electronic systems that are not included in

Eudamed shall be accessible to the Member States and to the

Commission. The information shall be accessible to notified bodies,

economic operators, sponsors and the public to the extent specified in the

provisions on the electronic systems referred to in paragraph 2.

The Commission shall ensure that public parts of Eudamed and, where

applicable, any of the electronic systems that are not included in

Eudamed, are presented in a user-friendly and easily-searchable format.’;

(e) paragraph 6 is replaced by the following:

‘6. Eudamed and, where applicable, any of the electronic systems that are

not included in Eudamed, shall contain personal data only insofar as

necessary for the electronic systems to collate and process information in

accordance with this Regulation. Personal data shall be kept in a form

which permits identification of data subjects for periods no longer than

those referred to in Article 10(8).’;

(f) Paragraph 8 is replaced by the following:

‘8. The Commission shall, by means of implementing acts, lay down the

detailed arrangements necessary for the setting up and maintenance of

Eudamed and, where applicable, any of the electronic systems that are

not included in Eudamed. Those implementing acts shall be adopted in

accordance with the examination procedure referred to in Article 114(3).

When adopting those implementing acts, the Commission shall ensure

that, as far as possible, the systems are developed in such a way as to

avoid having to enter the same information twice within the same

electronic system or in different electronic systems.’;

(g) paragraph 9 is replaced by the following:

‘9. In relation to its responsibilities under this Article and the processing of

personal data involved therein, the Commission shall be considered to be

the controller of Eudamed and its electronic systems as well as, where

applicable, any of the electronic systems that are not included in

Eudamed.’;

(26) Article 34(1) is replaced by the following:

‘1. The Commission shall, in collaboration with the MDCG, draw up the

functional specifications for Eudamed and, where applicable, any of the

electronic systems that are not included in Eudamed.’.

(27) Article 35 is amended as follows:

(a) the following paragraph 6a is inserted:

‘6a. Without prejudice to other administrative or judicial remedies, a

manufacturer or notified body may raise with the authority responsible

for notified bodies, in a duly substantiated manner, any unresolved

dispute arising from the application of the requirements set out in Annex

VII and the involvement of a notified body in the conformity assessment

in accordance with Article 52 and Annexes IX, X and XI. The authority

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shall hear and decide within 90 days. Where the manufacturer is

established in another Member State than the notified body, the authority

responsible for the notified body shall consult the competent authority of

the Member State where the manufacturer is established.

In duly justified cases, the authority responsible for notified bodies may

seek guidance from the MDCG, which it shall take duly into account.

Each authority responsible for notified bodies shall inform the

Commission and the MDCG at least annually about the disputes raised

with it pursuant to the first subparagraph, their outcome and the parties

involved. That information shall be taken into consideration in the

framework of the monitoring of notified bodies in accordance with

Article 44.

By way of derogation from the first subparagraph and without prejudice

to other administrative or judicial remedies, a Member State may choose

to assign the tasks set out in this paragraph to another authority or to an

out of court dispute resolution body.’;

(b) paragraph 8 is replaced by the following:

‘8. The authorities responsible for notified bodies shall coordinate their

activities to be carried out in accordance with this Chapter, cooperate

with each other and with the Commission and resolve issues of diverging

opinions between themselves to ensure a harmonised application of the

requirements relating to notified bodies.’;

(28) Article 36 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. Notified bodies shall fulfil the tasks for which they are designated in

accordance with this Regulation in the public interest. They shall satisfy

the organisational and general requirements and the quality management,

resource and process requirements, as set out in further detail in

Annex VII, that are necessary to fulfil those tasks in an effective,

independent, diligent and expeditious manner.

Notified bodies designated for conformity assessment activities relating

to devices that are high-risk AI systems as referred to in Article 6(1) of

Regulation (EU) 2024/1689, or that use high-risk AI systems as safety

components, shall also meet the requirements set out in Article 31(4), (5),

(10) and (11) of that Regulation.’;

(b) the following paragraph 4 is added:

‘4. The Commission is empowered to adopt delegated acts in accordance

with Article 115 in order to amend Annex VII in order to adapt to

technical or scientific progress regarding conformity assessment in the

field of medical devices, including developments at international level.’;

(29) in Article 37, paragraph 4 is deleted;

(30) Article 39 is replaced by the following:

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‘Article 39

Assessment of the application

1. The authority responsible for notified bodies shall within 30 days check that

the application referred to in Article 38 is complete and shall request the

applicant to provide any missing information. Once the application is complete,

that authority shall send it to the Commission.

2. Within 14 days of the receipt of the application referred to in paragraph 1 of

this Article, the Commission, in consultation with the MCDG, shall appoint

three experts, chosen from the list referred to in Article 40(2). In view of the

specific circumstances of the application, a different number of experts may be

appointed.

At least one of the experts shall be an expert representing the Commission. The

other experts shall be experts nominated by Member States other than the one

in which the applicant conformity assessment body is established.

In order to be chosen in accordance with the first subparagraph, the experts

shall be competent to assess the conformity assessment activities and the types

of devices which are the subject of the application.

3. The experts appointed in accordance with paragraph 2 and the authority

responsible for notified bodies shall form a joint assessment team that shall be

coordinated by the expert representing the Commission.

4. Within 90 days of the appointment of the experts in accordance with paragraph

3, the joint assessment team shall review the application and supporting

documentation and shall draw up a preliminary assessment report. During that

period, the joint assessment team may request any clarifications from the

applicant conformity assessment body. The joint assessment team shall submit

the preliminary assessment report to the applicant conformity assessment

body.

5. Where, based on the review of the application and supporting documentation

referred to in this paragraph, the joint assessment team considers that the

applicant body does not and, within a reasonable period of time, will not be

able to meet the requirements of this Regulation and that any further

assessment in accordance with paragraphs 6 to 9 is not appropriate, it shall

draw up a final assessment report and the authority responsible for the notified

bodies shall reject the application.

6. Unless the application is rejected, the joint assessment team shall plan and

conduct an on-site assessment of the applicant conformity assessment body

and, where relevant, of any subsidiary or subcontractor, located inside or

outside the Union, that is to be involved in the conformity assessment process.

Where an on-site assessment of the applicant body, a subsidiary or a

subcontractor is temporarily impossible or impracticable due to exceptional

circumstances, the joint assessment team may decide to carry out the

assessment by other appropriate means.

At the end of the on-site assessment, the joint assessment team shall list for the

applicant conformity assessment body any non-compliances resulting from the

assessment and summarise the assessment by the joint assessment team.

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7. Within 30 days after the finalisation of the on-site assessment, the joint

assessment team shall submit the assessment report to the applicant conformity

assessment body and, where applicable, inform that body about any non-

compliances resulting from the assessment.

Where the joint assessment team has not identified any non-compliances, its

assessment report shall be considered the final assessment report and paragraph

11 shall apply.

8. Where the joint assessment team has identified non-compliances, the applicant

conformity assessment body shall submit to the joint assessment team a

proposed corrective and preventive action plan to address the non-compliances

effectively and in a timely manner.

That plan shall indicate the root cause of the identified non-compliances and

shall include a timeframe for implementation of the actions therein.

9. Within 30 days of receipt of the proposed corrective and preventive action plan

referred to in paragraph 8, the joint assessment team shall assess whether the

non-compliances identified during the assessment have been appropriately

addressed and, where necessary, provide any comments on it to the applicant

conformity assessment body, including requests for further clarification and

modifications.

The applicant conformity assessment body and the joint assessment team shall

endeavour to agree on a final corrective and preventive action plan in due

course.

10. Within 30 days of receipt of the final corrective and preventive action plan, or

of the moment the joint assessment team concludes that no agreement on a

final plan has been reached, the joint assessment team shall draw up its final

assessment report. That report shall include the result of the assessment,

conclusions regarding the corrective and preventive action plans and whether

the non-compliances have been appropriately addressed and, where applicable,

the recommended scope of designation.

11. The joint assessment team shall submit its final assessment report to the

MCDG without undue delay.

Based on the findings of the final assessment report, the authority responsible

for notified bodies shall submit to the MDCG a draft decision on the

designation of the notified body or reject the application.

12. Within 21 days of receipt of the draft decision on the designation referred to in

paragraph 11, the MDCG shall issue a recommendation with regard to the

envisaged designation, which the authority responsible for notified bodies shall

duly take into consideration for its final decision on the designation of the

notified body. That 21-day period may be extended once for a further 21 days

on justified grounds.

13. Where the authority responsible for notified bodies does not agree with the

recommendation of the MDCG, it shall submit to the MDCG a duly justified

request to reconsider its recommendation. Within 30 days of receipt of that

request, the MDCG shall either confirm its recommendation or issue a new

recommendation.

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14. Where no agreement can be reached between the MDCG and the authority

responsible for notified bodies, either party may refer the matter to the

Commission.

Within 180 days of receipt of the referral, the Commission shall, after

consulting the MDCG, the authority responsible for notified bodies and, where

necessary, the applicant conformity assessment body concerned, evaluate the

draft decision on the designation and decide, by means of implementing act,

whether or not the draft designation is justified.

15. If, at any stage of the process, consensus cannot be reached within the joint

assessment team on any issue, any member of the joint assessment team may

refer the issue to the MDCG, which shall provide its views without undue

delay and at the latest within 60 days from the referral.

16. The Commission may, by means of implementing acts, adopt measures setting

out detailed arrangements specifying the procedures and any relevant

documentation for the following:

(a) the application for designation referred to in Article 38;

(b) the assessment of the application set out in this Article;

(c) the nomination and selection of experts referred to in Article 40;

(d) the monitoring of notified bodies pursuant to Article 44.

Those implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 114(3).’;

(31) Article 40 is amended as follows:

(a) the title is replaced by the following:

‘Nomination of experts for joint assessment’;

(b) paragraph 1 is replaced by the following:

‘1. All Member States that have appointed an authority responsible for

notified bodies and the Commission shall nominate experts who are

qualified in the assessment, designation or monitoring of conformity

assessment bodies in the field of medical devices or in the assessment of

manufacturers’ technical documentation and who will be available to

participate in the activities referred to in Articles  39, 44 and 48.

Member States that have not appointed an authority responsible for

notified bodies may nominate experts who have those qualifications.

The nominated experts shall commit to participate in joint assessments.’;

(32) the following Article 40a is inserted:

‘Article 40a

Funding of activities related to designation and

monitoring of notified bodies

1. Conformity assessment bodies and notified bodies shall pay a fee for the

assessment of their application for designation and their monitoring, including

the costs for the involvement of experts nominated in accordance with Article

40 in those assessment and monitoring activities.

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2. The structure and level of the fees and the scale and type of recoverable costs

shall be established by the Commission by means of implementing acts. Those

implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 114(3).’;

(33) the third paragraph of Article 41 is replaced by the following:

‘The applicant shall provide translations of the documentation pursuant to Articles 38

and 39, or parts thereof, into an official Union language, such as is necessary for that

documentation to be readily understood by the joint assessment team referred to in

Article 39(4).’;

(34) Article 42 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. Member States may only designate conformity assessment bodies in

accordance with the recommendation of the MDCG issued in accordance

with Article 39(11) or (12) or in accordance with an implementing act

adopted by the Commission in accordance with Article 39(14).’;

(b) paragraph 4 is replaced by the following:

‘4. The notification shall be accompanied by the recommendation of the

MDCG.’;

(c) paragraphs 6 to 9 are deleted;

(d) paragraph 10 is replaced by the following:

‘10. When publishing the notification in NANDO, the Commission shall add

to the electronic system referred to in Article 57 the information relating

to the notification of the notified body along with the documents referred

to in paragraph 4 of this Article.’;

(35) Article 44 is amended as follows:

(a) the title is replaced by the following:

‘Monitoring of notified bodies’;

(b) in paragraph 2, the second sentence is replaced by the following:

‘Notified bodies shall, upon request by their authority responsible for notified

bodies, supply all relevant information and documents required to enable the

authority and the joint assessment team to verify compliance.’;

(c) the following paragraph 3a is inserted:

‘3a. The authority responsible for notified bodies shall conduct its monitoring

and assessment activities in accordance with an assessment programme

considering the full scope of the notified body’s activities. That

programme shall ensure that the authority can effectively monitor the

continued compliance of the notified body with the requirements of this

Regulation and shall provide a reasoned schedule for the frequency of

assessment of the notified body and, where applicable, its subsidiaries

and/or subcontractors for a period of at least two years. The authority

responsible for notified bodies shall submit the programme for

monitoring or assessment for each notified body for which it is

responsible to the MDCG and to the Commission. The authority shall

EN 55 EN

address any request for clarification or modification made by the

Commission or the MDCG.’;

(d) paragraph 4 is replaced by the following:

‘4. At least once a year, the authorities responsible for notified bodies shall

assess whether each notified body established on their respective territory

and, where appropriate, the subsidiaries and subcontractors under the

responsibility of those notified bodies still satisfy the requirements and

fulfil their obligations set out in this Regulation, in particular Annex VII.

Where necessary, the assessment shall include an on-site audit of the

notified body, its subsidiaries or subcontractors.

The authority, the MDCG or the Commission may request the

participation of experts from the Commission and other Member States

in the annual assessment of a notified body.’;

(e) the following paragraphs 4a, 4b and 4c are inserted:

‘4a. At least every two years, the annual assessment of a notified body shall

be carried out by a joint assessment team including the authority

responsible for notified bodies and two experts from the list referred to in

Article 40(2) appointed by the Commission in consultation with the

MDCG. At least one of those experts shall be an expert representing the

Commission. In light of the specific circumstances of the monitoring, the

Commission may appoint a different number of experts. The joint

assessment team shall be coordinated by the expert representing the

Commission.

If, at any stage of the process, consensus cannot be reached within the

joint assessment team on any issue, any member of the joint assessment

team may refer the issue to the MDCG, which shall provide its views

without undue delay and at the latest within 60 days from the referral.

4b. At the end of any assessment carried out pursuant to paragraph 4 or 4a,

the authority responsible for notified bodies or the joint assessment team,

as applicable, shall inform the notified body about any non-compliances

resulting from the assessment and summarise their assessment.

Where non-compliances have been identified, the notified body shall

submit a proposed corrective and preventive action plan to address the

non-compliances. That plan shall indicate the root cause of the identified

non-compliances and shall include a timeframe for implementation of the

actions set out therein.

The authority responsible for notified bodies or the joint assessment

team, as applicable, shall assess whether the non-compliances identified

during the assessment have been appropriately addressed in the plan

referred to in the second subparagraph and, where necessary, provide any

comments on the plan to the notified body, including requests for further

clarification and modifications. The notified body and the authority or the

joint assessment team, as applicable, shall endeavour to agree on a final

corrective and preventive action plan in due course.

4c. After receipt of the final corrective and preventive action plan, or where

the authority responsible for notified bodies or the joint assessment team,

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as applicable, have not identified non-compliances or conclude that no

agreement on a final plan has been reached, the authority or the joint

assessment team, as applicable, shall draw up their final monitoring

report which shall include the result of the assessment and, where

applicable, conclusions regarding the corrective and preventive action

plan and, where applicable, any recommendations regarding the notified

body’s designation.

The authority responsible for notified bodies or the joint assessment

team, as applicable, shall submit their final monitoring report to the

MDCG without undue delay.

The authority responsible for notified bodies shall monitor the

implementation of the corrective and preventive action plan by the

notified body, as appropriate.

Where the final monitoring report concludes that the notified body no

longer meets the requirements set out in this Regulation, or where the

notified body fails to implement the corrective and preventive action

plan, the authority responsible for notified bodies shall follow the

procedure set out in Article 46(4).’;

(f) paragraph 5 is replaced by the following:

‘5. The monitoring of notified bodies shall include observed audits of

notified body personnel, including where necessary any personnel from

subsidiaries and subcontractors, as that personnel is in the process of

conducting quality management system assessments at a manufacturer's

facility.’;

(g) in paragraph 6, the first subparagraph is replaced by the following:

‘The monitoring of notified bodies shall consider data arising from market

surveillance, vigilance and post-market surveillance.’;

(h) paragraph 8 is replaced by the following:

‘8. During the monitoring of a notified body, an appropriate number of the

notified body’s assessments of manufacturers' quality management

system and technical documentation, in particular the clinical evaluation

documentation, shall be reviewed either off-site or on-site. The sampling

of files shall be representative of the types and risk of devices certified by

the notified body, in particular high-risk devices. ’;

(i) paragraphs 9, 10 and 11 are deleted;

(j) paragraph 12 is replaced by the following:

‘12. The authority responsible for notified bodies shall draw up an annual

summary of their monitoring activities regarding notified bodies and,

where applicable, subsidiaries and subcontractors. That summary shall be

made publicly available through the electronic system referred to in

Article 57.’;

(36) Article 45 is deleted;

(37) Article 46 is amended as follows:

(a) paragraphs 1 and 2 are replaced by the following:

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‘1. The authority responsible for notified bodies shall notify the Commission

and the MDCG of any application for relevant changes to the designation

of a notified body.

The procedures set out in Articles 39 and 42 shall apply to significant

extensions of the scope of the designation. By way of derogation from

Article 39, an on-site assessment shall not be conducted where the Joint

Assessment Team considers such assessment not to be necessary for the

assessment of the requested scope extension.

For changes to the designation other than significant extensions of its

scope, the procedures laid down in paragraphs 2 to 9 shall apply.

2. After having assessed the application for changes, the authority

responsible for notified bodies shall notify the Commission of the

relevant changes to the designation. The Commission shall without

undue delay publish the amended notification in NANDO. The

Commission shall also, without undue delay, enter information on the

changes to the designation of the notified body in the electronic system

referred to in Article 57.’;

(b) in paragraph 4, the first subparagraph is replaced by the following:

‘Where an authority responsible for notified bodies has ascertained that a

notified body no longer meets the requirements set out in this Regulation or

that it is failing to fulfil its obligations or has not implemented the necessary

corrective measures, the authority shall suspend, restrict, or fully or partially

withdraw the designation or impose conditions on the notified body, depending

on the seriousness of the failure to meet those requirements or fulfil those

obligations. A suspension shall not exceed a period of one year, renewable

once for the same period.’;

(38) Article 47 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. The Commission, in conjunction with the MDCG, shall investigate all

cases where concerns have been brought to its attention regarding the

continued fulfilment by a notified body, or of one or more of its

subsidiaries or subcontractors, of the requirements set out in this

Regulation. It shall ensure that the relevant authority responsible for

notified bodies is informed and is given an opportunity to investigate

those concerns.’;

(b) paragraph 3 is replaced by the following:

‘3. The Commission, in consultation with the MDCG, may initiate the

assessment by a joint assessment team as referred to in Article 39(2) to

(10), where there is reasonable concern about the ongoing compliance of

a notified body, or a subsidiary or subcontractor of the notified body,

with the requirements set out in the Regulation and where the

investigation by the authority responsible for notified bodies is not

deemed to have fully addressed the concerns or upon request of the

authority responsible for notified bodies. The reporting and outcome of

that assessment shall follow the principles set out in Article 39.’;

(39) Article 48 is amended as follows:

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(a) the title is replaced by the following:

‘Exchange of experience between authorities responsible for notified bodies’;

(b) paragraphs 2 to 5 are deleted;

(40) Articles 49 and 50 are replaced by the following:

‘Article 49

Coordination of notified bodies

1. The Commission shall ensure that appropriate coordination and cooperation

between notified bodies is put in place and operated in the form of a

coordination group of notified bodies in the field of medical devices, including

in vitro diagnostic medical devices. The coordination group shall meet on a

regular basis, at least annually, and report to the MDCG.

The Commission may establish the specific arrangements for the functioning of

the coordination group.

2. Notified bodies shall ensure that their specialised personnel participate in the

relevant activities of the coordination group.

3. All bodies notified under this Regulation and under Regulation (EU) 2017/746

shall actively participate in the work of the coordination group to support the

implementation of this Regulation and of Regulation (EU) 2017/746 by sharing

experience and developing common templates and technical guidance to

facilitate harmonisation and common approaches regarding conformity

assessment activities. They shall cooperate with each other, with the

Commission, with the relevant authorities of the Member States, with expert

panels and, where applicable, expert laboratories or European Union reference

laboratories to ensure a harmonised application of the requirements set out in

this Regulation and in Regulation (EU) 2017/746.

4. All bodies notified under this Regulation and under Regulation (EU) 2017/746

shall adhere to a code of conduct developed by the coordination group and

approved by the MDCG. The code of conduct shall set out the principles of

public interest, highest professional competence and integrity, impartiality,

independence, transparency, proportionality, predictability and accountability

to which notified bodies commit when exercising the rights and obligations

conferred on them by this Regulation or Regulation (EU) 2017/746.

Article 50

Access to notified bodies and fees

1. Notified bodies shall establish lists of their fees for the conformity assessment

activities that they carry out and shall make those lists publicly available. They

shall notify the lists to the Commission, which shall make references to them

available to the public on a dedicated website.

2. Notified bodies shall apply at least a 50 % fee reduction for manufacturers that

are micro enterprises within the meaning of Recommendation 2003/361/EC

and at least a 25 % fee reduction for small enterprises within the meaning of

that Recommendation. They shall apply at least a 50 % fee reduction for

manufacturers that apply for conformity assessment of an orphan device

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referred to in Article 52a(3). Notified bodies shall provide manufacturers that

are micro or small enterprises within the meaning of Recommendation

2003/361/EC the possibility to defer the payment of fees until the relevant

conformity assessment activity is finalised.

3. The Commission, in consultation with the MDCG, may adopt implementing

acts to specify the structure and level of the fees referred to in paragraph 1,

taking into account the need to:

(a) establish and maintain high standards of quality and safety of devices;

(b) ensure the availability of devices;

(c) protect the interests of micro, small or medium-sized enterprises within

the meaning of Recommendation 2003/361/EC;

(d) support innovation and competitiveness.

4. Notified bodies shall ensure that manufacturers, which are micro, small or

medium-sized enterprises within the meaning of Recommendation

2003/361/EC, have access to their conformity assessment activities in a manner

that is not less favourable than the manner in which access is provided to other

manufacturers.

5. Notified bodies shall deal with any request for conformity assessment activities

from a manufacturer and, within 15 days of receipt of the request, inform the

manufacturer accordingly.

6. When duly justified in the interest of public health or patient health or safety,

the authority responsible for notified bodies may instruct a notified body to

accept a manufacturer’s request for conformity assessment activities falling

within that notified body’s scope of designation.’;

(41) Article 51 is amended as follows:

(a) paragraph 2 is replaced by the following:

‘2. The competent authorities shall coordinate their activities when

determining the classification of a device, or a category or group of

devices. The results of the coordination activities of the competent

authorities, including the results of any decision or measure adopted by a

competent authority in accordance with Articles 51a or 51b and any

opinion issued by an expert panel in relation to classification, shall be

made publicly available, without disclosing any confidential information

as referred to in Article 109.’;

(b) in paragraph 3, point (b) is replaced by the following:

‘(b) that a device, or category or group of devices, shall for reasons of public

health based on new scientific evidence, or based on any information

which becomes available in the course of the vigilance and market

surveillance activities be reclassified, by way of derogation from

Annex VIII, taking into consideration the principle of proportionality and

classification of devices at international level.’;

(c) in paragraph 5, the first sentence is replaced by the following:

‘In order to ensure the uniform application of the rules set out in Annex VIII,

and taking account of the relevant scientific opinions of the relevant

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scientific committees or expert panels, the Commission is empowered to

adopt implementing acts to the extent necessary to resolve issues of

divergent interpretation and of practical application.’;

(d) the following paragraph 7 is added:

‘7. The Commission is empowered to adopt delegated acts in accordance

with Article 115 to amend Annex VIII in order to adapt it to technical or

scientific progress or to take into account developments regarding

classification of devices at international level.’;

(42) the following Articles 51a and 51b are inserted:

‘Article 51a

Classification in the event of a dispute between manufacturer and notified body

1. A manufacturer or a notified body may refer any dispute between them arising

from the application of Annex VIII to the competent authority of the

Member State in which the manufacturer has its registered place of business. In

cases where the manufacturer has no registered place of business in the Union

and has not yet designated an authorised representative, the matter shall be

referred to the competent authority of the Member State in which the

authorised representative referred to in Section 2.2, second paragraph,

point (b), last indent, of Annex IX has its registered place of business.

2. Within 30 days of receipt of the referral referred to in paragraph 1, the

competent authority shall consult the other Member States regarding its draft

classification decision.

3. Where, within 30 days of receipt of the consultation referred to in the

paragraph 2, no substantiated disagreement has been raised by a Member State,

the competent authority shall adopt its decision within 90 days of receipt of the

referral referred to in paragraph 1.

4. Where, within 30 days of receipt of the consultation referred to in paragraph 2,

a substantiated disagreement has been raised by a Member State regarding the

draft classification decision, the matter shall be referred to an expert panel as

referred to in Article 106. That expert panel shall deliver an opinion on the

classification of the device within 30 days. The competent authority may ask

the expert panel for clarifications on its opinion.

5. Within 30 days of receipt of the expert panel opinion, or any requested

clarification, referred to in paragraph 4, the competent authority shall adopt its

decision, giving utmost consideration to the expert panel opinion. It shall notify

the other Member States and the Commission of its decision without undue

delay.

6. The Commission may, by means of implementing acts, lay down further details

of the procedure for the application of this Article and of Article 51b. Those

implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 114(3).

Article 51b

Challenges to the classification of CE marked devices

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1. Where a competent authority, after having performed an evaluation in

accordance with Article 94, considers that a device that is CE marked in

accordance with Article 20, is not classified in accordance with Annex VIII, it

shall consult the other Member States regarding its envisaged measure on the

classification of the device.

2. Where, within 30 days of receipt of the consultation referred to in paragraph 1,

no substantiated disagreement is raised by a Member State, the competent

authority may adopt the measure on the classification of the device in question

and shall notify the other Member States and the Commission of its decision

giving the reasons for the decision.

3. Where, within 30 days of receipt of the consultation referred to in paragraph 1,

a substantiated disagreement is raised by a Member State regarding the

envisaged measure on the classification, the matter shall be referred to an

expert panel referred to in Article 106, which shall deliver an opinion on the

classification of the device within 30 days. The competent authority may ask

the expert panel for clarifications on its opinion.

4. The competent authority shall give utmost consideration to the expert panel

opinion. Where the competent authority adopts a measure on the classification,

it shall notify the other Member States and the Commission of its measure

without undue delay.’;

(43) Article 52 is amended as follows:

(a) in paragraph 3, the following subparagraph is added:

‘By way of derogation from the first subparagraph, class III devices that are

well-established technology devices shall be subject to a conformity

assessment as specified in Chapters I and III of Annex IX, including an

assessment of the technical documentation of one representative device per

generic device group.’;

(b) paragraph 4 is replaced by the following:

‘4. Manufacturers of class IIb devices, other than custom-made or

investigational devices, shall be subject to a conformity assessment as

specified in Chapters I and III of Annex IX, including an assessment of

the technical documentation of one representative device per generic

device group or, in the case of non-implantable class IIb devices that are

well-established technology devices, one representative device per each

category of devices.

By way of derogation from the first subparagraph, for class IIb

implantable devices, except well-established technology devices, the

assessment of the technical documentation as specified in Section 4 of

Annex IX shall apply for every device. Alternatively, the manufacturer

may choose to apply a conformity assessment based on type examination

as specified in Annex X coupled with a conformity assessment based on

product conformity verification as specified in Annex XI. ‘;

(c) paragraph 5 is deleted;

(d) paragraph 6 is replaced by the following:

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‘6. Manufacturers of class IIa devices, other than custom-made or

investigational devices, shall be subject to a conformity assessment as

specified in Chapters I and III of Annex IX, including an assessment of

the technical documentation of one representative device for each

category of devices.

Alternatively, the manufacturer may choose to draw up the technical

documentation set out in Annexes II and III coupled with a conformity

assessment as specified in Section 10 or Section 18 of Annex XI. The

assessment of the technical documentation shall apply for one

representative device for each category of devices.’;

(e) paragraph 7 is amended as follows:

(i) the second sentence is replaced by the following:

‘If those devices are placed on the market in sterile condition, have a

measuring function or are reusable surgical instruments, the manufacturer

shall apply the procedures set out in Chapters I and III of Annex IX, or in

Section 10a of Annex XI’;

(ii) the following subparagraph is added:

‘Where the manufacturer of class I reusable surgical instruments has

applied harmonised standards or CS covering all relevant aspects referred

to in the first subparagraph, point (c), the involvement of a notified body

is not required.’;

(f) paragraph 12 is replaced by the following:

‘12. The documents relating to the procedures referred to in paragraphs 1 to 7

shall be available in any official Union language acceptable to the

notified body.’;

(g) in paragraph 14, the first subparagraph is replaced by the following:

‘The Commission may, by means of implementing acts, specify detailed

arrangements and procedural aspects for any of the following aspects:

(a) the basis for the selection of the representative device for the

assessment of the technical documentation as referred to in

paragraphs 3, 4 and 6;

(b) the modalities of unannounced on-site audits and sample tests to be

conducted by notified bodies in accordance with Section 3.4 of

Annex IX, taking into account the risk-class and the type of device,

(c) the physical, laboratory or other tests to be carried out by notified

bodies in the context of sample tests, assessment of the technical

documentation and type examination;

(d) the modalities of the conformity assessment procedures regarding

breakthrough devices and orphan devices set out in Article 52a;’;

(h) the following paragraph 15 is added:

‘15. The Commission is empowered to adopt delegated acts in accordance

with Article 115 to amend Annexes IX, X, XI and XIII in order to adapt

to technical or scientific progress or to developments regarding

conformity assessment of devices at international level and to take into

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account the needs of particular devices in view of their special

characteristics.’;

(44) the following Articles 52a and 52b are inserted:

‘Article 52a

Conformity assessment of breakthrough devices and of orphan devices

1. For the conformity assessment of breakthrough devices and orphan devices, for

which a notified body is involved in the conformity assessment, the procedures

laid down in Article 52 shall apply subject to the specific arrangements set out

in this Article.

2. A device shall be considered a breakthrough device if it meets the following

criteria:

(a) it is expected to introduce in the Union a high degree of novelty with

respect to the device technology, related clinical procedure or the

application of the device in clinical practice;

(b) it is expected to provide a significant positive clinical impact on patients

or public health, for a life-threatening or irreversibly debilitating disease

or condition, by either of the following: 

(i) offering a significant positive clinical or health impact compared to

available alternatives and the state of the art;

(ii) fulfilling an unmet medical need where there is an absence or

insufficiency of available alternative options for that purpose.

3. A device shall be considered an orphan device if it meets the following

criteria: 

(a) it is intended for the treatment, diagnosis, or prevention of a disease or

condition that presents in not more than 12 000 individuals in the Union

per year;

(b) at least one of the following criteria is met:

(i) there are insufficient available alternatives;

(ii) the device is expected to provide a clinical benefit compared to

available alternatives or the state of the art, taking into account both

device-specific factors and patient population-specific factors.

4. Upon a duly substantiated request by a manufacturer or a notified body, an

expert panel referred to in Article 106 shall provide an opinion as to whether

the criteria set out in paragraph 2 or 3 of this Article, as applicable, are

fulfilled. That opinion shall be published on a dedicated website without

disclosing any confidential information as referred to in Article 109 and shall

be duly taken into consideration by the manufacturer and the notified body.

5. Where the opinion of the expert panel confirms the fulfilment of the criteria set

out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough

device or of an orphan device, as applicable, may request advice from the

expert panels referred to in Article 106 regarding its clinical development

strategy and appropriate preclinical or clinical data for the clinical evaluation

of the device.

EN 64 EN

6. For a confirmed breakthrough device or an orphan device, as applicable, the

notified body involved in the conformity assessment procedure set out in

Article 52 shall prioritise the conformity assessment of that device and apply,

where appropriate, a rolling review with a view to reduce assessment timelines.

The notified body shall give due consideration to an opinion or advice provided

by the expert panels in accordance with paragraph 4 or 5 and, where it does not

follow such opinion or advice, it shall provide duly justified reasons. The

notified body may ask the expert panel to clarify the opinion it has provided.

7. The notified body shall issue a certificate pursuant to Article 56 where the pre-

market clinical evidence, even if based on limited clinical data, is deemed

adequate, provided that either of the following conditions is fulfilled:

(a) the benefit of the immediate availability on the market of the device

outweighs the risk associated with the fact that additional clinical data are

still required;

(b) the benefit-risk-ratio of the device is favourable and the manufacturer

commits to providing additional data from post-market clinical follow-up

activities.

Where appropriate, the notified body shall limit the validity of the certificate

and specify any conditions for or limitations to the certificate’s validity in

accordance with Article 56, such as a requirement for the manufacturer to

conduct specific post-market clinical follow-up activities within a specified

period of time.

8. The Commission is empowered to adopt delegated acts in accordance with

Article 115 in order to amend this Article to adapt to technical or scientific

progress or to take into account developments regarding conformity assessment

of breakthrough devices or orphan devices at international level.

9. The Commission may, by means of implementing acts, lay down further details

of the procedure for the conformity assessment of breakthrough devices or

orphan devices set out in this Article. Those implementing acts shall be

adopted in accordance with the examination procedure referred to in Article

114(3).

Article 52b

Digitalisation of technical documentation, conformity assessment and reports

1. The manufacturer may draw up and make available in a digital format the

technical documentation and any reports or other documents required pursuant

to this Regulation. That digital format may be a structured machine-readable

format, provided that it is possible to transform it into human-readable format,

and that there is version-control to enable the conduct of retrospective

conformity checks. Where the technical documentation, reports or other

documents are to be submitted to and assessed by a notified body, the

manufacturer shall agree with the notified body on the digital format.

2. Where necessary to ensure that the digital format referred to in paragraph 1 is

reliable, interoperable and standardised, the Commission may establish

minimum requirements or functional specifications for the digital format by

means of common specifications as referred to in Article 9.’;

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(45) in Article 53, paragraph 5 is replaced by the following:

‘5. Notified bodies and the personnel of notified bodies shall carry out their

conformity assessment activities in the public interest and with the highest

degree of professional integrity and the requisite technical and scientific

competence in the specific field and shall be free from all pressures and

inducements, particularly financial, which might influence their judgement or

the results of their conformity assessment activities, especially as regards

persons or groups with an interest in the results of those activities.’;

(46) Articles 54 and 55 are replaced by the following:

‘Article 54

Clinical evaluation consultation procedure for certain high-risk devices

1. In addition to the procedures applicable pursuant to Article 52, a notified body

shall follow the procedure regarding clinical evaluation consultation as

specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X,

as applicable, when performing a conformity assessment of class III

implantable devices, other than custom-made devices.

Where justified in order to protect the health and safety of patients, users or

other persons or other aspects of public health, the Commission is empowered

to adopt delegated acts in accordance with Article 115 to amend paragraph 1 in

order to add other types of devices to those devices that are subject to the

clinical evaluation consultation procedure referred to in the first subparagraph.

2. By way of derogation from paragraph 1, the procedure referred to in that

paragraph is not required in the following cases:

(a) for a renewal of a certificate issued under this Regulation;

(b) where the device has been designed by modifying a device already

marketed for the same intended purpose, provided that the manufacturer

has demonstrated to the satisfaction of the notified body that the

modifications do not adversely affect the benefit-risk ratio of the device;

(c) where the principles of the clinical evaluation of the device type or

category have been addressed in a harmonised standard referred to in

Article 8 or in CS referred to in Article 9 and the notified body confirms

that the clinical evaluation of the manufacturer for this device is in

compliance with the relevant harmonised standard or CS for clinical

evaluation of that kind of device.

3. The notified body shall notify the competent authorities, the authority

responsible for notified bodies and the Commission through the electronic

system referred to in Article 57 of whether or not the procedure referred to in

paragraph 1 of this Article is to be applied. That notification shall be

accompanied by the clinical evaluation assessment report.

4. The notified body shall give utmost consideration to the opinion issued by the

expert panel in the framework of the clinical evaluation consultation procedure.

Where the notified body has not followed the views and recommendations

expressed in that opinion, it shall provide a substantiated justification of the

reasons therefore and its final clinical evaluation assessment report to the

EN 66 EN

authority responsible for notified bodies of the Member State in which it is

established, to the expert panel that issued the opinion and to the Commission.

Article 55

Mechanism for scrutiny of conformity assessments

1. The MDCG or the Commission may, based on reasonable concerns, request

advice from an expert panel in relation to the safety and performance of any

device. For that purpose, the MDCG or the Commission may request the

notified body that issued the certificate for the device in question to submit to

the expert panel its clinical evaluation assessment report and any subsequent

surveillance assessment reports regarding that device. The expert panel may

request the notified body or the manufacturer to submit additional information

needed for its assessment.

2. The MDCG or the Commission may, based on reasonable concerns, request

advice from one or more expert laboratories, based on laboratory testing, in

relation to the safety and performance of any device, provided that the device

falls within the scope of designation of those expert laboratories. For that

purpose, the MDCG or the Commission may request the notified body that

issued the certificate for the device in question to submit to the expert

laboratories its clinical evaluation assessment report and any subsequent

surveillance assessment reports regarding that device. The expert laboratories

may request the notified body or the manufacturer to submit samples of the

device or any additional information needed for their assessment.

3. The notified body shall give utmost consideration to the advice provided by the

expert panel or the expert laboratory and, where needed, take any appropriate

measures, including those referred to in Article 56(3) and (4).’;

(47) Article 56 is amended as follows:

(a) paragraphs 1 and 2 are replaced by the following:

‘1. The notified bodies shall issue certificates in accordance with

Annexes IX, X and XI in an official Union language and immediately

upload them in Eudamed. The minimum content of the certificates shall

be as set out in Annex XII.

2. The validity of certificates shall not be limited in time, unless in

exceptional cases where the notified body considers it necessary to limit

the period of validity based on duly justified grounds. In those cases, the

notified body shall indicate the period of validity on the certificate. If the

period of validity of the certificate is limited, on application by the

manufacturer, the notified body may, following an assessment performed

in accordance with Annex VII, Section 4.11, extend the validity of the

certificate. Any supplement to a certificate shall remain valid as long as

the certificate which it supplements is valid.’

(b) the following paragraph 2a is inserted:

‘2a. During the validity of the certificate, the notified body shall carry out

appropriate surveillance activities, including periodic reviews taking into

consideration developments of the state of the art. Those reviews shall be

proportionate to the risk class of the device.’;

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(c) paragraph 3 is replaced by the following:

‘3. Notified bodies may impose conditions on the validity of the certificate,

such as limiting the intended purpose of a device to certain groups of

patients or requiring the manufacturer to undertake specific PMCF

studies pursuant to Part B of Annex XIV.’;

(d) in paragraph 4, the first sentence is replaced by the following:

‘Where a notified body finds that the requirements of this Regulation are no

longer met by the manufacturer, it shall, taking account of the principle of

proportionality, suspend or withdraw the certificate issued or impose any

conditions on it unless compliance with such requirements is ensured by

appropriate corrective action taken by the manufacturer within an appropriate

deadline set by the notified body.’;

(e) in paragraph 5, the first sentence is replaced by the following:

‘The notified body shall enter in the electronic system referred to in Article 57

any information regarding certificates issued, including amendments and

supplements thereto, and regarding suspended, reinstated, withdrawn or

refused certificates and conditions imposed on certificates.’;

(48) Article 57 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) point (f) is replaced by the following:

‘(f) the notifications for conformity assessments and information or

documents referred to in Article 54(3) and (3a);’;

(ii) point (i) is deleted;

(49) Article 59 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. By way of derogation from Article 52 and on a duly justified request, any

competent authority may authorise for a limited period of time the

placing on the market or putting into service within the territory of the

Member State concerned of a specific device for which the applicable

conformity assessment procedures have not been carried out, provided

that the use of that device is in the interest of public health, patient safety

or patient health.’;

(b) the following paragraph 1a is inserted:

‘1a. By way of derogation from Article 6(2) and on a duly justified request,

any competent authority may authorise for a limited period of time the

provision of a diagnostic or therapeutic service referred to in that Article

to a natural or legal person established within the territory of the Member

State concerned using a device for which the applicable conformity

assessment procedures set out in this Regulation have not been carried

out, provided that the provision of that service is in the interest of public

health, patient safety or patient health.’;

(c) paragraph 2 is replaced by the following:

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‘2. The Member State shall inform the Commission, the other Member States

and the relevant expert panels referred to in Article 106 of any decision

to authorise the placing on the market or putting into service of a device,

or the provision of a service, in accordance with paragraph 1 or 1a, where

such authorisation is granted for use other than for a single patient.

The Member State shall also make information about such authorisations

publicly available.’;

(d) in paragraph 3, the first subparagraph is replaced by the following:

‘3. Where a request pursuant to paragraph 1 or paragraph 1a has been

submitted to competent authorities in more than one Member State and

based on an opinion of an expert panel referred to in Article 106, the

Commission, in exceptional cases relating to public health, patient safety

or patient health, may, by means of implementing acts, extend for a

limited period of time the validity of an authorisation granted by a

Member State in accordance with paragraph 1 or paragraph 1a to the

territory of the Union, or provide an authorisation referred to in

paragraph 1 or paragraph 1a for the territory of the Union. The

Commission may set out the conditions under which the device may be

placed on the market or put into service, or under which the diagnostic or

therapeutic service may be provided. Those implementing acts shall be

adopted in accordance with the examination procedure referred to in

Article 114(3).’;

(e) the following paragraphs 4 and 5 are added:

‘4. In the event of a public health emergency at Union level recognised in

accordance with Article 23 of Regulation (EU) 2022/2371 of the

European Parliament and of the Council*****, the Commission may, by

means of implementing acts, on its own initiative after consulting the

MDCG, authorise the placing on the market or putting into service of a

device in accordance with paragraph 3. The authorisation shall cease to

apply at the latest when the recognition of the public health emergency is

terminated pursuant to Article 23(2) of Regulation (EU) 2022/2371.

Those implementing acts shall be adopted in accordance with the

examination procedure referred to in Article 114(3). 

On duly justified imperative grounds of urgency relating to the health and

safety of humans, the Commission may adopt immediately applicable

implementing acts in accordance with the procedure referred to in

Article 114(4).

5. The Commission may, by means of implementing acts, lay down rules

further specifying the procedure set out in this Article. Those

implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 114(3).’;

____________________

***** Regulation (EU) 2022/2371 of the European Parliament and of the

Council of 23 November 2022 on serious cross-border threats to health

and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26,

ELI: http://data.europa.eu/eli/reg/2022/2371/oj).’;

EN 69 EN

(50) the following Articles 59a, 59b and 59c are inserted:

‘Article 59a

Derogations from certain requirements in the event of a serious cross-border threat to

health, disaster or crisis

1. Upon a duly justified request by the manufacturer, a competent authority may

authorise for a limited period of time, by way of derogation from the relevant

provisions in Annexes II, III, IX, X and XI, an exemption from the

requirements related to changes to the manufacturing, design or intended

purpose of a CE marked device, where it is in the interest of public health,

patient safety or patient health, in either of the following circumstances:

(a) a serious cross-border threat to health as defined in Article 3, point (1), of

Regulation (EU) 2022/2371;

(b) a disaster or a crisis within the meaning of Regulation (EU) …/… of the

European Parliament and of the Council******+.

2. The manufacturer shall ensure that the manufactured devices remain in

conformity with the relevant general safety and performance requirements set

out in Annex I.

3. The competent authority may request the notified body that issued a certificate

for the device in question, to assist it in the assessment of a request referred to

in paragraph 1.

4. Where applicable, the manufacturer shall keep the notified body that issued a

certificate for the device in question, informed about any changes made

regarding the manufacturing, design or intended purpose of a CE marked

device in accordance with the authorisation referred to in paragraph 1.

5. Where a request pursuant to paragraph 1 has been submitted to competent

authorities in more than one Member State, the Commission, in exceptional

cases relating to public health, patient safety or patient health, may, by means

of implementing acts, extend for a limited period of time the validity of an

exemption granted by a Member State in accordance with paragraph 1 to the

territory of the Union, or provide an exemption referred to in paragraph 1 for

the territory of the Union. Those implementing acts shall be adopted in

accordance with the examination procedure referred to in Article 114(3). 

+ OJ: Please insert in the text the number of the Regulation contained in 2025/0223(COD) (Proposal for a

Regulation on the Union Civil Protection Mechanism and Union support for health emergency

preparedness and response, and repealing Decision No 1313/2013/EU) and insert the number, date, title

and OJ reference of that Regulation in the footnote.

EN 70 EN

On duly justified imperative grounds of urgency relating to the health and

safety of humans, the Commission may adopt immediately applicable

implementing acts in accordance with the procedure referred to in

Article 114(4).

___________________

****** Regulation (EU) .../... of the European Parliament and of the Council of

... on ... (OJ ..., ELI ).

Article 59b

Regulatory sandboxes at national level

1. Member States, on their own initiative or upon a substantiated request by a

manufacturer or a prospective manufacturer, may establish one or more

regulatory sandboxes to which the application of certain requirements of

Chapters V or VI or of Annexes I, VIII IX, X, XI, XIV or XV would not be

appropriate. The Member States shall designate the competent authority that is

responsible for the supervision of the regulatory sandbox.

Member States may also establish regulatory sandboxes jointly with other

Member States.

2. The activities within a regulatory sandbox shall take place pursuant to a

specific sandbox plan that shall clearly identify the requirements of this

Regulation referred to in paragraph 1, which, by way of derogation from this

Regulation, are temporarily adapted or waived in the regulatory sandbox, a

justification that the application of those requirements is considered not

appropriate and an explanation as to how potential risks related to the

adaptation or waiver are controlled and mitigated. The plan shall also identify

the reasonable duration of the regulatory sandbox necessary to achieve its

objectives and the participants in the regulatory sandbox and their respective

roles.

3. A regulatory sandbox shall be set up only if the following conditions are met:

(a) the device is expected to address unmet medical needs or to provide a

significant clinical benefit to patients or to the health system compared

with similar existing alternatives or the state of the art;

(b) the application of the requirements of this Regulation referred to in

paragraph 1 would impede or significantly delay the development of the

device and access by healthcare professionals or lay users to such device.

4. The Member State may request an expert panel referred to in Article 106 to

provide scientific, technical or regulatory advice on the draft sandbox plan.

5. Any participant in the regulatory sandbox shall, without undue delay, inform

the competent authority that is responsible for the supervision of the regulatory

sandbox about any harm occurred in relation to the implementation of the

regulatory sandbox. The competent authority shall take immediate and

adequate corrective measures, including to suspend, revoke or restrict the scope

of the regulatory sandbox.

6. Manufacturers and prospective manufacturers participating in a regulatory

sandbox shall remain liable under applicable Union and national law for any

EN 71 EN

damage inflicted on third parties as a result of their activities taking place in the

regulatory sandbox.

7. The Member State shall inform the Commission and the MDCG about the

establishment of a regulatory sandbox and keep them informed about its

implementation and outcome.

Article 59c

Union regulatory sandboxes

1. The Commission, on its own initiative or upon a substantiated request by a

Member State, may establish, by means of implementing acts for a limited time

and pursuant to a specific plan, Union regulatory sandboxes, which shall

inform whether the existing requirements appropriately regulate a specific type

of device with particular characteristics or emerging technologies, and there is

a risk that the existing requirements:

(a) would impede or significantly delay the development of such devices and

access by healthcare professionals or lay users to those devices; or

(b) would not adequately protect the health and safety of patients, users or

other persons or other aspects of public health.

Union regulatory sandboxes shall not involve the placing on the market or

putting into service of devices which do not comply with this Regulation.

2. The Commission shall request an expert panel as referred to in Article 106 to

provide scientific, technical or regulatory advice on the design of a Union

regulatory sandbox.

3. The Commission shall inform the MDCG about the establishment of a

regulatory sandbox and keep it informed about its outcome.

4. The Commission may, by means of implementing acts, specify common

principles or the detailed arrangements for the establishment, operation and

supervision of regulatory sandboxes pursuant to Article 59b or of Union

regulatory sandboxes pursuant to this Article. Those implementing acts shall be

adopted in accordance with the examination procedure referred to in Article

114(3).

5. The Commission is empowered to adopt delegated acts in accordance with

Article 115 to amend this Article or Article 59b in order to adapt it to scientific,

technical or regulatory progress and to take into account developments

regarding regulatory sandboxes, including in areas other than medical

devices.’;

(51) in Article 60, the following paragraphs 1a and 1b are inserted:

‘1a. The person referred to in Article 22(1) or (3) may request the competent

authority of the Member State where it is established to issue a certificate of

free sale for a system or procedure pack for which it has drawn up a statement

in accordance with Article 22.

1b. The competent authority shall make the certificates of free sale issued in

accordance with paragraphs 1 and 1a publicly available in Eudamed.’;

(52) Article 61 is amended as follows:

EN 72 EN

(a) paragraphs 1 and 2 are replaced by the following:

‘1. Manufacturers shall plan, conduct and document a clinical evaluation in

accordance with this Article and with Part A of Annex XIV to confirm

the safety and performance of the device under normal conditions of use

in accordance with the intended purpose of the device, and shall evaluate

any undesirable side-effects and the acceptability of the benefit-risk ratio

referred to in Sections 1 and 8 of Annex I.

The manufacturer shall specify and justify the level of clinical evidence

necessary to confirm the safety and performance of the device. That level

of clinical evidence shall be appropriate in view of the characteristics of

the device and its intended purpose, taking into consideration paragraph

10.

The clinical evaluation, its results and the clinical evidence derived from

it shall be documented in a clinical evaluation report as referred to in

Section 4 of Annex XIV, which, except for custom-made devices, shall

be part of the technical documentation referred to in Annex II relating to

the device concerned.

2. For class IIb and class III devices, a manufacturer may, prior to its

clinical investigation or clinical evaluation, consult an expert panel as

referred to in Article 106, with the aim of reviewing the manufacturer's

intended clinical development strategy or proposals for clinical

investigation. The manufacturer and the notified body involved in any

future conformity assessment procedure shall, in the clinical evaluation

report and the clinical evaluation assessment report, give due

consideration to the advice of the expert panel and where they do not

follow the advice, they shall provide duly justified reasons.’;

(b) in paragraph 4, first subparagraph, the introductory wording is replaced by the

following:

‘In the case of implantable class IIb devices and class III devices, other than

custom-made devices, clinical investigations shall be performed, except if:’;

(c) paragraph 5 is replaced by the following:

‘5. A manufacturer of a device demonstrated to be equivalent to an already

marketed device not manufactured by it, may also rely on paragraph 4 in

order not to perform a clinical investigation provided that the original

clinical evaluation has been performed in compliance with the

requirements of this Regulation and the manufacturer provides clear

evidence thereof to the notified body.’;

(d) paragraph 6 is amended as follows:

(i) the introductory wording is replaced by the following:

‘The requirement to perform clinical investigations pursuant to

paragraph 4 shall not apply to implantable class IIb devices and class III

devices:’;

(ii) point (b) is replaced by the following:

‘(b) that are well-established technology devices for which the clinical

evaluation is based on sufficient clinical evidence and is in

EN 73 EN

compliance with the relevant product-specific CS, where such CS

are available.’;

(e) paragraph 8 is deleted;

(f) paragraphs 10 and 11 are replaced by the following:

’10. Without prejudice to paragraph 4, where the confirmation of safety and

performance based on clinical data is not deemed appropriate, adequate

justification shall be given based on the results of the manufacturer's risk

management and on consideration of the specifics of the interaction

between the device and the human body, the clinical performance

intended and the claims of the manufacturer and the data available for the

generic device group. In such a case, the manufacturer shall duly

substantiate in the technical documentation referred to in Annex II why it

considers a demonstration of conformity with general safety and

performance requirements that is based on the results of non-clinical

testing methods alone, including performance evaluation, bench testing,

in vitro, ex vivo, in silico testing, computational modeling or simulation

and pre-clinical evaluation, to be adequate.

11. The clinical evaluation, its documentation and, where applicable and

needed, the summary of safety and performance referred to in Article 32

shall be updated throughout the life cycle of the device concerned with

data and findings obtained from the implementation of the manufacturer's

PMCF plan in accordance with Part B of Annex XIV and the post-market

surveillance plan referred to in Article 84, whenever those data and

findings obtained from PMCF provide information relevant for the

confirmation of safety and performance of the device.’

(g) paragraph 12 is deleted;

(h) the following paragraph 14 is added:

‘14. The Commission is empowered to adopt delegated acts in accordance

with Article 115 to amend Annex XIV in order to adapt it to technical

and scientific progress and developments at international level, having

due regard to the protection of the health and safety of patients, users or

other persons and other aspects of public health.’;

(53) in Article 62, the introductory wording is replaced by the following:

‘Clinical investigations shall be designed, authorised, conducted, recorded and

reported in accordance with the provisions of this Article, of Articles 63 to 73 and of

Articles 75 to 80, the acts adopted pursuant to Article 81, and Annex XV, where they

are carried out to assess an investigational device that has not been placed on the

market or put into service in accordance with this Regulation and where carried out

for one or more of the following purposes:’;

(54) in Article 64(1), point (g) is replaced by the following:

‘(g) there are scientific grounds for expecting that participation in the clinical

investigation will produce either of the following:

(i) a direct benefit to the incapacitated subject outweighing the risks and

burdens involved;

EN 74 EN

(ii) a benefit for the population represented by the incapacitated subject

provided that the clinical investigation poses only minimal risk to, and

imposes minimal burden on, the incapacitated subject in comparison with

the standard treatment of the subject's condition.’;

(55) in Article 65, point (g) is replaced by the following:

‘(g) there are scientific grounds for expecting that participation in the clinical

investigation will produce either of the following:

(i) a direct benefit to the minor subject outweighing the risks and burdens

involved;

(ii) a benefit for the population represented by the minor subject provided

that the clinical investigation will pose only minimal risk to, and will

impose minimal burden on, the minor subject in comparison with the

standard treatment of the subject's condition.’;

(56) in Article 66, point (a) is replaced by the following:

‘(a) the clinical investigation has the potential to produce a direct benefit for the

pregnant or breastfeeding woman concerned, or her embryo, foetus or child

after birth, outweighing the risks and burdens involved, or if the clinical

investigation has not the potential to produce such direct, the following

conditions are met:

(i) a clinical investigation of comparable effectiveness cannot be carried out

on women who are not pregnant or breastfeeding;

(ii) the clinical investigation contributes to the attainment of results capable

of benefitting pregnant or breastfeeding women or other women in

relation to reproduction, or other embryos, foetuses or children;

(iii) the clinical investigation poses a minimal risk to, and imposes a minimal

burden on, the pregnant or breastfeeding woman concerned, her embryo,

foetus or child after birth;’;

(57) in Article 68(1), point (b) is replaced by the following:

‘(b) there are scientific grounds to expect that participation of the subject in the

clinical investigation will have the potential to produce either of the following:

(i) a direct clinically relevant benefit for the subject resulting in a

measurable health-related improvement alleviating the suffering and/or

improving the health of the subject, or in the diagnosis of its condition;

(ii) a benefit for the population represented by the subject provided that the

clinical investigation will pose only minimal risk to, and will impose

minimal burden on, the subject in comparison with the standard treatment

of the subject's condition;’;

(58) in Article 72, the following paragraph 7 is added:

‘7. The processing of personal data in the context of a clinical investigation,

including the secondary use of personal data initially collected for other

investigations, shall be deemed to be carried out for scientific research

purposes as referred to in Article 9(2), point (j), of Regulation (EU)

2016/679.’;

(59) in Article 74, paragraph 1 is replaced by the following:

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‘1. Where a clinical investigation is to be conducted to further assess, within the

scope of its intended purpose and in accordance with its PMCF plan, a device

which already bears the CE marking in accordance with Article 20(1), (‘PMCF

investigation’), and where the investigation would involve submitting subjects

to procedures additional to those performed under the normal conditions of use

of the device and those additional procedures are invasive or burdensome, the

sponsor shall notify the Member States concerned at least 30 days prior to its

commencement by means of the electronic system referred to in Article 73.

The sponsor shall include the documentation referred to in Chapter II, Sections

1, 3 and 4, of Annex XV as part of the notification. Article 62(4), points (b) to

(k) and (m), Article 75(1), Articles 76 and 77, Article 80(5) and (6), and the

relevant provisions of Annex XV shall apply to PMCF investigations involving

additional invasive or burdensome procedures.;

(60) Article 75 is amended as follows:

(a) in paragraph 1, the first sentence is replaced by the following:

‘If a sponsor intends to introduce modifications to a clinical investigation that

are likely to have a substantial impact on the safety, health or rights of the

subjects or on the robustness or reliability of the clinical data generated by the

investigation, it shall notify, by means of the electronic system referred to in

Article 73, the Member State(s) in which the clinical investigation is being or is

to be conducted of the reasons for and the nature of those modifications.’;.

(b) paragraph 2 is replaced by the following:

‘2. Where the clinical investigation has been the subject of an authorisation

in accordance with Article 62(4), point (a), the Member State shall assess

any substantial modification to the clinical investigation in accordance

with the procedure laid down in Article 71.’;

(c) in paragraph 3, the introductory wording is replaced by the following:

‘The sponsor may implement the modifications referred to in paragraph 1 as

soon as the Member State concerned has notified the sponsor of its

authorisation or, where there is no authorisation, at the earliest 38 days after the

notification from the sponsor referred to in that paragraph, unless:’;

(61) Article 78 is amended as follows:

(a) in paragraph 4, the second subparagraph is replaced by the following:

‘The final assessment report shall be taken into account by all Member States

concerned when deciding on the sponsor's application in accordance with

paragraph 11.’;

(b) paragraph 5 is replaced by the following:

‘5. Each Member State concerned may request, on a single occasion,

additional information from the sponsor. The sponsor shall submit the

requested additional information within 12 days of receipt of the request.

The expiry of the last deadline pursuant to paragraph 4, point (d), shall be

suspended from the date of the request until such time as the additional

information has been received.’;

(c) in paragraph 6, the reference to ‘50 days’ is replaced by ‘20 days’;

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(d) the following paragraph 15 is added:

‘15. The Commission is empowered to adopt delegated acts in accordance

with Article 115 to amend this Article in light of experience gained from

the practical application of the coordinated assessment procedure, in

particular as regards timelines and the authorisation of clinical

investigations subject to a coordinated assessment.’;

(62) Article 79 is deleted;

(63) the following Article 79a is inserted:

‘Article 79a

Clinical investigations in combined studies

Clinical investigations that are part of combined studies, and which are subject to

authorisation in accordance with Article 62, may be carried out in accordance with

Article 14c of Regulation (EU) No 536/2014.

If the sponsor chooses to apply Article 14c of Regulation (EU) No 536/2014, the

requirements laid down therein and in any implementing or delegated acts adopted in

accordance with that Article shall apply instead of the corresponding requirements

laid down in this Regulation.’;

(64) Article 82 is deleted;

(65) in Article 83(4), the first sentence is replaced by the following:

‘If in the course of the post-market surveillance, a need for preventive or corrective

action, or both, is identified, the manufacturer shall implement the appropriate

measures. The competent authorities concerned may request the manufacturer to

inform them when such preventive or corrective action is taken to reduce a risk that

may compromise the safety or performance of the device.’;

(66) in Article 84, the second sentence is deleted;

(67) Article 86 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) in the first subparagraph, the first sentence is replaced by the following:

‘Manufacturers of class IIa, class IIb and class III devices, other than

custom-made devices, shall prepare a periodic safety update report

(‘PSUR’) for each device, or where relevant for each category or group

of devices, summarising the results and conclusions of the analyses of the

post-market surveillance data gathered as a result of the post-market

surveillance plan referred to in Article 84, together with a description of

any preventive and corrective actions taken, including their rationale.’;

(ii) the second and third subparagraphs are replaced by the following:

‘Manufacturers of class IIb and class III devices shall update the PSUR

in the first year after the certificate is issued and every two years

thereafter or when there is a significant change in the benefit-risk

determination or in the acceptability of undesirable side-effects. The

PSUR shall be part of the technical documentation as specified in

Annex III.

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Manufacturers of class IIa devices shall update the PSUR when

necessary. The PSURs shall be part of the technical documentation

specified in Annex III. ‘;

(iii) the fourth subparagraph is deleted.

(b) paragraph 2 is replaced by the following:

‘2. For class III devices or class IIb implantable devices, other than well-

established technology devices, the notified body shall review the PSUR

during the surveillance assessment. The manufacturer and the notified

body shall make such PSURs and the evaluation by the notified body

available to competent authorities through the electronic system referred

to in Article 92.’;

(68) Article 87 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) in the first subparagraph, point (a) is replaced by the following

‘(a) any serious incident involving devices made available on the Union

market, except expected undesirable side-effects which are clearly

documented in the product information and quantified in the

technical documentation and are subject to trend reporting pursuant

to Article 88;’:

(ii) the second subparagraph is replaced by the following:

‘The reports referred to in the first subparagraph shall be submitted

without undue delay through the electronic system referred to in

Article 92.’;

(b) paragraph 3 is replaced by the following:

‘3. Manufacturers shall report any serious incident as referred to in

paragraph 1, first subparagraph, point (a), immediately after they have

established that there is a causal relationship between that incident and their

device or that such causal relationship is reasonably possible and not later than

30 days after they become aware of the incident.’;

(69) the following Article 87a is inserted:

‘Article 87a

Reporting of actively exploited vulnerabilities and severe incidents related to devices

1. Without prejudice to the reporting obligations regarding serious incidents and

field safety corrective actions set out in Article 87, the manufacturer of a

device shall report to the computer security incident response teams

(‘CSIRTs’), designated as coordinators of the Member States where a device

has been made available, and to the European Union Agency for Cybersecurity

(ENISA), either of the following:

(a) any actively exploited vulnerability as defined in Article 3, point (42), of

Regulation (EU) 2024/2847 of the European Parliament and of the

Council******* contained in the device;

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(b) any severe incident as referred in Article 14(5) of Regulation (EU)

2024/2847 having an impact on the security of the device.

2. The manufacturer shall submit the report referred to in paragraph 1 through the

electronic system referred to in Article 92 not later than 30 days after it

becomes aware of the actively exploited vulnerability or the severe incident.

3. The report referred to in paragraph 1, as well as any report submitted by a

manufacturer in accordance with Article 87 that also qualifies as actively

exploited vulnerability or severe incident, shall be made available

simultaneously to the CSIRTs designated as coordinators of the Member States

in which the device has been made available and to ENISA.

4. For the purposes of this Article, the CSIRTs designated as coordinators and

ENISA shall have access to Eudamed.’

_______________

******* Regulation (EU) 2024/2847 of the European Parliament and of the Council

of 23 October 2024 on horizontal cybersecurity requirements for products with

digital elements and amending Regulations (EU) No 168/2013 and (EU)

2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L,

2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj).’;

(70) in Article 88(1), the first sentence is replaced by the following:

‘Manufacturers shall report, by means of the electronic system referred to in

Article 92, any statistically significant increase in the frequency or severity of

incidents that are not serious incidents or that are expected undesirable side-effects

that could have a significant impact on the benefit-risk analysis referred to in

Sections 1 and 8 of Annex I.’;

(71) Article 89 is amended as follows:

(a) in paragraph 1, the second subparagraph is replaced by the following:

‘The manufacturer shall cooperate with the competent authorities during the

investigations referred to in the first subparagraph and shall not perform any

investigation which involves altering the device or a sample of the batch

concerned in a way which may affect any subsequent evaluation of the causes

of the incident, prior to informing the competent authorities of such action.’;

(b) paragraph 2 is replaced by the following:

‘2. Member States shall take the necessary steps to ensure that any

information regarding a serious incident that has occurred within their

territory, or a field safety corrective action that has been or is to be

undertaken within their territory, and that is brought to their knowledge

in accordance with Article 87 is evaluated centrally at national level by

their competent authority, if possible together with the manufacturer.’;

(c) the following paragraph 3a is inserted:

‘3a. The competent authority may request the notified body that issued a

certificate for the device in question in accordance with Article 56 to

provide assistance in evaluating a corrective action related to a serious

incident or a field safety corrective action.’;

(d) paragraph 6 is replaced by the following:

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‘6. In the case of devices referred to in Article 1(8), first subparagraph, and

where the serious incident or field safety corrective action is confirmed by the

manufacturer to be related to a substance which, if used separately, would be

considered to be a medicinal product, the evaluating competent authority or the

coordinating competent authority referred to in paragraph 9 shall inform the

national competent authority or the EMA, which issued the scientific opinion

on that substance in accordance with Article 52(9), of that serious incident or

field safety corrective action.

In the case of devices falling within the scope of this Regulation in accordance

with Article 1(6), point (g), or in accordance with Article 1(10), the competent

authority or the coordinating competent authority referred to in paragraph 9 of

this Article shall inform the competent authority for substances of human

origin that was consulted by the notified body in accordance with

Article 52(10), provided that the serious incident or field safety corrective

action is confirmed by the manufacturer to be related to the derivatives of

substances of human origin utilised for the manufacture of the device or to the

non-viable substances of human origin or their derivatives that have an action

ancillary to that of the device.’;

(e) paragraph 7 is replaced by the following:

‘7. If, after carrying out the evaluation in accordance with paragraph 3 of

this Article, the evaluating competent authority identifies the need for

additional corrective actions from the manufacturer to minimise the risk

of recurrence of the serious incident, it shall, through the electronic

system referred to in Article 92, inform, without delay, the other

competent authorities of the corrective action taken or envisaged by the

manufacturer or required of it to minimise the risk of recurrence of the

serious incident, including information on the underlying events and the

outcome of its assessment.’;

(f) in paragraph 9, the introductory wording is replaced by the following:

‘The competent authorities shall actively participate in a procedure in order to

coordinate their assessments referred to in paragraph 3 whenever such

coordination is needed to ensure a high level of protection of the health and

safety of patients, users and other persons or the protection of public health

throughout the Union, and in particular in the following cases:’;

(72) in Article 91, the first subparagraph is amended as follows:

(a) the introductory wording is replaced by the following:

‘The Commission may, by means of implementing acts, and after consultating

the MDCG, adopt the detailed arrangements and procedural aspects necessary

for the implementation of Articles 84 to 90 and Article 92 as regards the

following:’;

(b) point (b) is replaced by the following:

‘(b) the reporting of serious incidents and field safety corrective actions and

field safety notices, and the provision and content of the post-market

surveillance plan, periodic summary reports, post-market surveillance

reports, PSURs and trend reports by manufacturers as referred to in

Articles 84, 85, 86, 87, 88 and 89 respectively;’;

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(73) in Article 92(2), the reference to ‘Article 53’ is replaced by ‘Article 56’;

(74) Article 93 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. The competent authorities shall perform appropriate checks on the

conformity characteristics and performance of devices and on the

compliance of economic operators with the obligations set out in this

Regulation including, where appropriate, a review of documentation and

physical or laboratory checks on the basis of adequate samples. The

competent authorities shall, in particular, take account of established

principles regarding risk assessment and risk management, vigilance data

and complaints.’;

(b) the following paragraph 1a is inserted:

‘1a. Member States shall ensure that their national competent authorities are

provided with adequate and sufficient technical, financial and human

resources, and with infrastructure to fulfil their tasks effectively under

this Regulation.’;

(c) paragraph 2 is replaced by the following:

‘2. The competent authorities shall draw up annual surveillance activity

plans, taking into account the European market surveillance programme,

which shall be developed and maintained by the MDCG, and local

circumstances.’;

(d) the following paragraph 12 is added:

‘12. In respect of devices that are high-risk AI systems as referred to in

Article 6(1) of Regulation (EU) 2024/1689, the competent authorities

shall cooperate with market surveillance authorities of their Member

State designated in accordance with Article 70 of Regulation (EU)

2024/1689.’;

(75) Article 94 is replaced by the following:

‘Article 94

Evaluation of devices suspected of presenting an unacceptable risk or other non-

compliance

The competent authorities of a Member State shall, alone or in cooperation with the

competent authorities of other Member States, carry out an evaluation of a device of

of an economic operator covering all the relevant requirements laid down in this

Regulation relating to the risk presented by the device, or to any other non-

compliance of the device or of the economic operator, where they, based on data

obtained by vigilance or market surveillance activities or on other information, have

reason to believe either of the following:

(a) the device may present an unacceptable risk to the health or safety of patients,

users or other persons, or to other aspects of the protection of public health;

(b) the device or the economic operator concerned otherwise does not comply with

the requirements laid down in this Regulation.

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The relevant economic operators and, where applicable and requested, the notified

body that issued a certificate for the device in question shall cooperate with the

competent authorities.

The competent authorities of the Member States may request any economic operator

or notified body to submit documentation available to them, where access to such

documentation is needed in the interest of public health or patient safety or health.’;

(76) Article 95 is amended as follows:

(a) paragraph 3 is replaced by the following:

‘3. The economic operators as referred to in paragraph 1 shall, without delay,

ensure that all appropriate corrective action is taken, within the period

referred to in paragraph 1, throughout the Union in respect of all the

devices concerned that they have made available on the market.’;

(b) paragraph 7 is amended as follows:

(i) the first subparagraph is replaced by the following:

‘Where, within two months of receipt of the notification referred to in

paragraph 4, no objection has been raised by either a Member State or the

Commission in respect of the notified measures taken by a Member

State, those measures shall be deemed to be justified.’;

(ii) in the second subparagraph, the following sentence is added:

‘Paragraph 4 shall not apply to such measures adopted by the Member

States.’;

(77) Article 96 is amended as follows:

(a) in paragraph 1, the third sentence is deleted;

(b) in paragraph 2, the second sentence of the first subparagraph is replaced by the

following:

‘If the Commission considers that the national measure is unjustified, the

Member State concerned, as well as any Member State that has taken

corresponding restrictive or prohibitive measures, shall withdraw the

measure.’;

(78) Article 97 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. Where, having performed an evaluation pursuant to Article 94, the

competent authorities of a Member State find that a device or an

economic operator does not comply with the requirements laid down in

this Regulation but does not present an unacceptable risk to the health or

safety of patients, users or other persons, or to other aspects of the

protection of public health, they shall require the relevant economic

operator to bring the non-compliance concerned to an end within a

reasonable period that is clearly defined and communicated to the

economic operator and that is proportionate to the non-compliance.’;

(b) in paragraph 2, the first sentence is replaced by the following:

‘Where the economic operator does not bring the non-compliance to an end

within the period referred to in paragraph 1, the Member State concerned

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shall, without delay, take all appropriate measures to restrict or prohibit

the product being made available on the national market or to ensure that

it is recalled or withdrawn from the national market.’;

(c) the following paragraph 2a is inserted:

‘2a. The economic operator shall take any appropriate corrective action

pursuant to paragraph 1 or 2 throughout the Union in respect of all the

devices concerned that they have made available on the market, unless a

competent authority takes other appropriate measures.’;

(79) in Article 98(3), the fourth sentence is deleted;

(80) the title of Chapter VIII is replaced by the following:

‘COOPERATION BETWEEN MEMBER STATES, THE MDCG, EXPERT

LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS, CONFLICTS OF

INTEREST AND INTERNATIONAL COOPERATION’;

(81) after the title of Chapter VIII, the following title is inserted:

‘SECTION 1

Cooperation between Member States, the MDCG, expert panels, expert laboratories and

device registers and conflict of interests’;

(82) Article 101 is replaced by the following:

‘Article 101

Competent authorities

The Member States shall designate the competent authority or authorities responsible

for the implementation and practical application of this Regulation. They shall ensure

that those authorities are entrusted with sufficient powers, resources, equipment and

knowledge to effectively and efficiently perform their tasks pursuant to this

Regulation. The Member States shall communicate the names and contact details of

the competent authorities to the Commission which shall publish a list of competent

authorities.’;

(83) in Article 102, paragraph 2 is deleted;

(84) Article 103 is amended as follows:

(a) in paragraph 2, second subparagraph, the second sentence is replaced by the

following:

‘They shall represent the competent authorities of the Member States and the

authorities responsible for notified bodies of the Member States, as

applicable.’;

(b) paragraph 7 is replaced by the following:

‘7. The MDCG shall establish a sub-group with members representing the

authorities responsible for notified bodies and may establish other

standing or temporary sub-groups. Where appropriate, representatives of

the coordination group referred to in Article 49 and organisations

representing the interests of the medical device industry, in particular of

micro, small and medium-sized enterprises within the meaning of

Recommendation 2003/361/EC, healthcare professionals, laboratories,

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patients and consumers at Union level shall be invited to the MDCG and

its sub-groups in the capacity of observers.’;

(c) paragraph 9 is replaced by the following:

‘9. The MDCG shall have the tasks laid down in Article 105 of this

Regulation.’;

(85) in Article 104, the second sentence is deleted;

(86) Articles 105 and 106 are replaced by the following:

‘Article 105

Tasks of the MDCG

In addition to the tasks assigned to it in other provisions of this Regulation and

Regulation (EU) 2017/746, the MDCG shall in particular assist the Commission

in the assessment of any issue related to the implementation of those Regulations

and contribute to the development of guidance aimed at ensuring their effective

and harmonised implementation.

Article 106

Expert panels

1. The Commission shall, by means of implementing acts and following

consultation with the MDCG, make provision for expert panels to be

designated to provide scientific, clinical, technical or regulatory opinions and

advice in relation to the implementation of this Regulation and of Regulation

(EU) 2017/746 to the Commission, the MDCG, Member States, notified bodies

or manufacturers.

Expert panels may be designated on a standing or temporary basis.

2. Expert panels shall consist of experts with proven up-to-date clinical, scientific,

technical or regulatory expertise in the field of medical devices or in vitro

diagnostic medical devices reflecting the diversity of scientific and clinical

approaches in the Union.

Experts shall be appointed following publication of a call for expressions of

interest. Depending on the type of task and the need for specific expertise,

experts may be appointed to the panels for a maximum period of three years

and their appointment may be renewed.

When expert panels are requested to provide an opinion on the regulatory

status of a product which involves aspects concerning the borderline with other

types of products, experts with expertise in the field of the relevant other

products shall be involved.

3. The experts shall observe the principles of highest scientific competence and

perform their tasks with impartiality, objectivity and transparency. They shall

neither seek nor take instructions from notified bodies or manufacturers. Each

expert shall draw up a declaration of interests, which shall be made publicly

available.

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4. Expert panels shall take into account relevant information provided by

stakeholders including patients' organisations and healthcare professionals’

associations.

5. Experts may be included on a list of available experts who, whilst not being

formally appointed to a panel, are available to provide advice and to support

the work of the expert panels as needed.

6. Experts from notified bodies shall not be involved in the clinical evaluation

consultation procedure provided for in Article 54(1).

7. In addition to the tasks assigned to them in other provisions of this Regulation

and of Regulation (EU) 2017/746, the expert panels may have the following

tasks:

(a) to provide scientific, clinical, technical and regulatory advice to the

Commission, the MDCG, Member States or notified bodies in relation to

the implementation of this Regulation or Regulation (EU) 2017/746;

(b) to contribute to the development and maintenance of appropriate

guidance and CS supporting the implementation of this Regulation or

Regulation (EU) 2017/746;

(c) to contribute to the development of standards at Union or international

level, ensuring that such standards reflect the state of the art;

(d) to contribute to the identification of concerns and emerging issues

concerning the safety and performance of medical devices, including in

vitro diagnostic medical devices.

8. When adopting their opinions or advice, the members of the expert panels shall

use their best endeavours to reach consensus. If consensus cannot be reached,

the expert panels shall decide by a majority of their members, and the opinion

or advice shall mention the divergent positions and the grounds on which they

are based.

9. The Commission shall require manufacturers and notified bodies to pay fees

for opinions and advice provided by expert panels. The structure and the level

of the fees, as well as the scale and type of recoverable costs, shall be

established by the Commission by means of implementing acts, taking into

account the objectives of the adequate implementation of this Regulation,

protection of health and safety, support of innovation and cost-effectiveness

and the necessity to achieve active participation in the expert panels. Those

implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 114(3).

The fees referred to in the first subparagraph shall be established in a

transparent manner and on the basis of the costs for the services provided. The

fees shall be reduced for manufacturers which are micro, small or medium-

sized enterprises within the meaning of Recommendation 2003/361/EC,

including in the case of a clinical evaluation consultation procedure initiated in

accordance with Section 5.1, point (c), of Annex IX involving a manufacturer

who is a micro, small or medium-sized enterprise within the meaning of

Recommendation 2003/361/EC. The fees related to the opinions and advice

provided by expert panels are payable to EMA pursuant to Article 30, point (f),

of Regulation (EU) 2022/123.

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10. The Commission is empowered to adopt delegated acts in accordance with

Article 115 to amend paragraph 7 of this Article by adding, adapting or

removing tasks from the list of tasks of the expert panels.’;

(87) the following Articles 106a and 106b are inserted:

‘Article 106a

Expert laboratories

1. The Commission may, by means of implementing acts and following

consultation with the MDCG, designate expert laboratories, on the basis of

their expertise in the field of testing of medical devices, such as physico-

chemical characterisation, microbiological, biocompatibility, mechanical,

electrical, electronic or non-clinical toxicological testing of specific devices,

categories or groups of devices.

The Commission shall only designate expert laboratories for which a

Member State or the Joint Research Centre has submitted an application for

designation.

2. Expert laboratories shall satisfy the following criteria:

(a) have adequate and appropriately qualified staff with adequate knowledge

and experience in the field of the devices for which they are designated;

(b) have at their disposal the necessary equipment to carry out the tasks

assigned to them;

(c) have the necessary knowledge of international standards and best

practices;

(d) have an appropriate administrative organisation and structure;

(e) ensure that their staff observe the confidentiality of information and data

obtained in carrying out their tasks;

(f) act in the public interest and in an independent manner.

3. Expert laboratories may have the following tasks:

(a) to provide scientific and technical assistance to the Commission, the

MDCG, the EMA, Member States and notified bodies in relation to the

implementation of this Regulation;

(b) to contribute to the development and maintenance of appropriate

guidance and CS supporting the implementation of this Regulation;

(c) to contribute to the development of standards at Union or international

level, ensuring that such standards reflect the state of the art;

(d) to contribute to identification of concerns and emerging issues on the

safety and performance of medical devices;

(e) to provide scientific and technical assistance to Member States and the

Commission in vigilance and market surveillance activities.

4. The Commission is empowered to adopt delegated acts in accordance with

Article 115 to amend paragraph 3 of this Article by adding, adapting or

removing tasks from the list of tasks of the expert laboratories.

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5. The expert laboratories may charge fees in accordance with predetermined and

transparent terms and conditions for scientific and technical assistance

provided to the EMA, Member States or notified bodies for carrying out the

requested task. For the provision of services within the public interest on

request of the Commission or the MDCG, the expert laboratories may be

granted a Union financial contribution.

Article 106b

Support by the EMA

1. The EMA shall, on behalf of the Commission, provide scientific, technical and

administrative support to the national competent authorities designated under

this Regulation and under Regulation (EU) 2017/746 to facilitate the exchange

of experience, cooperation and coordination with a view to ensuring a uniform

application of such Regulations, in particular in the following areas:

(a) regulatory status of products and classification of devices in accordance

with Articles 4, 4a, 51, 51a and 51b of this Regulation and Articles 3, 3a,

47, 47a and 47b of Regulation (EU) 2017/746;

(b) derogations from the applicable conformity assessment procedures in

accordance with Articles 59 and 59a of this Regulation and Articles 54

and 54a of Regulation (EU) 2017/746;

(c) clinical evaluation, clinical investigations, performance evaluation and

performance studies in accordance with Chapter VI of this Regulation

and Chapter VI of Regulation (EU) 2017/746, including support to the

coordinating Member State for the coordinated assessment procedure for

clinical investigations and performance studies referred to in Article 78

of this Regulation and Article 74 of Regulation (EU) 2017/746;

(d) vigilance and market surveillance in accordance with Chapter VII of this

Regulation and Chapter VII of Regulation (EU) 2017/746, including

support to the coordinating competent authority for the coordinated

procedure referred to in Article 89(9) of this Regulation and Article 84(9)

of Regulation (EU) 2017/746.

2. The EMA shall provide scientific, technical and administrative support to the

Commission for the establishment of Union regulatory sandboxes in

accordance with Article 59c of this Regulation and Article 54c of Regulation

(EU) 2017/746.

3. The EMA shall set up a support scheme for manufacturers of medical devices

and in vitro diagnostic medical devices, which are micro, small and medium-

sized within the meaning of Recommendation 2003/361/EC, regarding the

requirements of this Regulation and of Regulation (EU) 2017/746.

4. The EMA shall have access to Eudamed and any electronic system referred to

in Article 33(2) of Regulation (EU) 2017/745 or in Article 30(2) of Regulation

(EU) 2017/746 that is not included in Eudamed.’;

(88) in Article 107(1), the fourth and fifth sentences are replaced by the following:

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‘The declaration of interests shall be made publicly available. This Article shall not

apply to the representatives of stakeholder organisations participating in the MDCG

or its sub-groups.’;

(89) in Article 108, the first sentence is replaced by the following:

‘The Commission, the Member States and the EMA shall take all appropriate

measures to encourage the establishment of registers and databanks for specific types

of devices, where appropriate including in vitro diagnostic medical devices, setting

common principles to collect comparable information.’;

(90) the following Section 2 is inserted after Article 108:

‘SECTION 2 – International cooperation

Article 108a

International regulatory and administrative cooperation

1. The Commission shall pursue international regulatory cooperation in the field

of medical devices and in vitro diagnostic medical devices with a view to

promoting a high level of protection of public health and patient safety,

fostering innovation and enhancing efficiency of regulatory compliance

through global convergence. For that purpose, the Commission and the

Member States shall contribute to the development and adoption of global

principles, standards, and guidance which provide a high level of international

convergence in the field of medical devices and in vitro diagnostic medical

devices, including in relation to safety, performance, quality management

systems, conformity assessment, and post-market surveillance.

2. The Commission shall participate in relevant international fora in the field of

medical devices and in vitro diagnostic medical devices, including the

International Medical Device Regulators Forum (IMDRF), the Medical Device

Single Audit Programme (MDSAP) and International Standardisation

Organisations.

3. In its activities in accordance with paragraphs 1 and 2, the Commission shall be

supported by experts nominated by the Member States in view of their

competence in medical devices or in vitro diagnostic medical devices.

4. The Commission may sign administrative arrangements with authorities of

third countries and with international organisations for the purpose of

regulatory cooperation in the field of medical devices and in vitro diagnostic

medical devices, including:

(a) exchange of information and best practices;

(b) joint or coordinated inspections and assessments;

(c) coordinated actions relating to safety issues, including recalls or safety

communications.

Where the Commission signs such administrative arrangements which include

the exchange of information or data, the administrative arrangement shall

provide for protection of such information or data in accordance with Article

109 of this Regulation or in Article 102 of Regulation (EU) 2017/746, as

applicable.

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5. The Union shall finance the activities of the Commission and the Member

States relating to international cooperation as referred to in this Article and the

reliance mechanisms referred to in Article 108b.

Article 108b

Reliance mechanisms

1. The Commission, may participate in bilateral or multilateral reliance

mechanisms or reliance programmes in the field of medical devices and in vitro

diagnostic medical devices, which shall enable the use of assessments,

inspections, and other regulatory decisions carried out or taken by regulatory

authorities of third countries or international organisations or international

bodies, provided that the following conditions are fulfilled:

(a) the reliance mechanism or reliance programme ensures a level of health

and safety protection equivalent to that required under this Regulation or

Regulation (EU) 2017/746, as applicable;

(b) effective arrangements for mutual exchange of information, transparency,

and oversight are in place, providing for the confidentiality of

information and data referred to in Article 109 of this Regulation or

Article 102 of Regulation (EU) 2017/746, as applicable.

2. The Commission may invite Member States to nominate experts, in view of

their competence in medical devices or in vitro diagnostic medical devices,

who participate in reliance mechanisms or reliance programmes referred to in

paragraph 1.

3. Reliance mechanisms or reliance programmes referred to in paragraph 1 shall

be taken into consideration by competent authorities, economic operators or

notified bodies in the framework of the implementation of this Regulation or of

Regulation (EU) 2017/746, as applicable.

4. The Commission may adopt implementing acts establishing detailed rules for

the recognition of reliance mechanisms or reliance programmes, which may

include conditions for participation of notified bodies to reliance mechanisms

or reliance programmes, requirements relating to the scope of assessments,

inspections or other regulatory decisions carried out or taken in the course of

reliance mechanisms or reliance programmes, and procedural safeguards for

manufacturers. Those implementing acts shall be adopted in accordance with

the examination procedure referred to in Article 114(3).

Article 108c

Capacity building and technical assistance

1. The Commission may support the strengthening of regulatory capacity in third

countries, including through the provision of technical assistance, training,

exchange of experts, and dissemination of best practices.

2. The Commission may invite Member States to nominate experts, in view of

their competence in medical devices or in vitro diagnostic medical devices, to

participate in its activities referred to in paragraph 1.

EN 89 EN

3. The activities referred to in paragraph 1 may be financed through relevant

Union programmes or external action instruments.’;

(91) the following Article 110a is added:

‘Article 110a

Submission of information or documents

The submission of information or documents in accordance with this Regulation

shall take place electronically.’;

(92) in Article 111, paragraph 1 is replaced by the following:

‘1. This Regulation shall be without prejudice to the possibility for Member States

and the Commission to levy fees for the activities set out in this Regulation,

provided that the level of the fees is set in a transparent manner and on the

basis of cost-recovery principles.’;

(93) Article 112 is deleted;

(94) Article 116 is deleted;

(95) in Article 120, the following paragraphs 14 and 15 are added:

‘14. By way of derogation from Article 5 and from paragraphs 3 to 3e of this

Article, a device as referred to in paragraph 3a or 3b of this Article that meets

the criteria for an orphan device as referred to in Article 52a(3) may be placed

on the market or put into service after the dates referred to in paragraphs 3a and

3b of this Article if the following conditions are met:

(a) an expert panel referred to in Article 106 has issued an opinion

confirming the fulfilment of the criteria for an orphan device as referred

to in Article 52a(3);

(b) there are no significant changes in the design and intended purpose of the

device;

(c) the device does not present an unacceptable risk to the health or safety of

patients, users or other persons, or to other aspects of the protection of

public health.

The requirements of this Regulation, with the exception of Chapters IV, V and

VI, shall apply to a device referred to in the first subparagraph.

By way of derogation from Article 86(1), manufacturers of class IIa devices,

class IIb devices and class III devices placed on the market or put into service

in accordance with this paragraph shall update the PSUR at least annually. On

an annual basis, the manufacturer shall submit the PSUR and, where

applicable, an update of the summary of safety and clinical performance to the

competent authority of the Member State in which it is established.

The competent authority of the Member State may require the manufacturer to

conduct defined post-market surveillance or PMCF activities within a specified

period of time to generate additional clinical data to confirm the safety and

performance of the device and to evaluate any undesirable side-effects and the

acceptability of the benefit-risk ratio.

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Devices placed on the market or put into service in accordance with this

paragraph, which do not have a valid certificate in accordance with paragraph

2, shall not bear the CE marking. In its EU declaration of conformity, the

manufacturer shall make reference to the fact that the device is an orphan

device placed on the market or put into service in accordance with this

provision.

The manufacturer shall inform the intended users about the fact that the device

is an orphan device placed on the market or put into service in accordance with

this provision, where applicable, in the summary of safety and clinical

performance and in the instructions for use or any other accompanying

documentation.

At least every 10 years, the manufacturer shall request an opinion from an

expert panel referred to in Article 106 confirming the fulfilment of the criteria

for an orphan device as referred to in Article 52a(3).

15. As regards devices for which a conformity assessment procedure is pending on

…[OP please insert the date = six months after the date of entry into force of

this Regulation], or for which a certificate is issued by a notified body before

that date, the manufacturer and the notified body may agree to continue

applying the provisions of this Regulation in the form applicable before …[OP

please insert the date = six months after the date of entry into force of this

Regulation] until the conformity assessment procedure is finalised or until the

certificate is renewed.’;

(96) Article 121 is replaced by the following:

‘Article 121

Evaluation

No sooner than …[Publications Office, please insert the date five years after the date

of application of this Regulation], the Commission shall carry out an evaluation of

this Regulation and present a report on the main findings to the European Parliament

and the Council.

Member States and notified bodies shall provide the Commission with the

information necessary for the preparation of that report.’

(97) in Article 123(3), point (d), the following third subparagraph is added:

‘After the date of application of the provisions referred to in the first subparagraph of

this point, where Member States maintain national databases, the relevant

information available in Eudamed for those national databases shall be retrieved

from Eudamed.’;

(98) Annexes I, II, III, VI, VII, VIII, IX, X, XI, XII, XIII, XIV and XV are amended in

accordance with Annex I to this Regulation.

Article 2

Amendments to Regulation (EU) 2017/746

Regulation (EU) 2017/746 is amended as follows:

(1) Article 1(4) is replaced by the following:

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‘4. Any device which, when placed on the market or put into service, incorporates,

as an integral part, a medical device as defined in Article 2, point (1), of

Regulation (EU) 2017/745 that has an action ancillary to that of the in vitro

diagnostic medical device, the integral product shall be governed by this

Regulation. In that case, the relevant general safety and performance

requirements set out in Annex I to Regulation (EU) 2017/745 shall apply as far

as the safety and performance of the medical device part are concerned.

However, if the action of the medical device is principal and not ancillary to

that of the in vitro diagnostic medical device, the integral product shall be

governed by Regulation (EU) 2017/745. In that case, the relevant general

safety and performance requirements set out in Annex I to this Regulation shall

apply as far as the safety and performance of the in vitro diagnostic medical

device part are concerned.’;

(2) Article 2 is amended as follows:

(a) in point (2), first subparagraph, point (f) is replaced by the following:

‘(f) to define or monitor therapeutic measures.’;

(b) in point (7), the introductory wording is replaced by the following:

‘‘companion diagnostic’ means a device which is essential for the safe and

effective use of one or more corresponding medicinal product(s) to:’;

(c) point (8) is replaced by the following:

‘(8) ‘generic device group’ means a set of devices having the same or similar

intended purposes and a commonality of technology allowing them to be

classified in a generic manner not reflecting specific characteristics;’;

(d) the following points (75), (76), (77) and (78) are added:

‘(75) ‘combined study’ means a clinical trial as defined in Article 2(2), point

(2), of Regulation (EU) No 536/2014, combined with a performance

study, and/or a clinical investigation as defined in Article 2, point (45), of

Regulation (EU) 2017/745;

(76) ‘regulatory sandbox’ means a controlled environment set up by

a competent authority which offers manufacturers or prospective

manufacturers the possibility to develop, test, validate and use, where

appropriate in real-world conditions, an innovative product or technology

potentially falling within the scope of this Regulation, pursuant to

a sandbox plan for a limited time under regulatory supervision’;

(77) ‘sandbox plan’ means a document agreed between the participating

manufacturer(s) or prospective manufacturer(s) and the competent

authority describing the objectives, conditions, timeframe, methodology

and requirements for the activities carried out within the regulatory

sandbox;

(78) ‘Union regulatory sandbox’ means a controlled envrironment set up by

the Commission for testing alternative or new regulatory requirements or

enforcement practices and appraising their validity in comparison with

existing requirements and practices under this Regulation for a limited

time.’;

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(3) Article 3 is replaced by the following

‘Article 3

Regulatory status of products

1. The competent authorities of the Member States shall coordinate their activities

when determining whether a specific product, or category or group of products,

falls within the definition of an ‘in vitro diagnostic medical device’ or of an

‘accessory for an in vitro diagnostic medical device’.

2. The Member States shall ensure an appropriate level of consultation of the

relevant competent authorities of the Member States in the fields of medical

devices, medicinal products, substances of human origin (SoHO), biocides,

food, cosmetics or other products subject to Union legislation, where the

determination of the regulatory status of a product involves aspects concerning

the borderline with any of those types of products. In that case, Member States

shall also ensure an appropriate level of consultation of the relevant advisory or

regulatory bodies established in the relevant Union legislation, such as the

European Medicines Agency (EMA), the SoHO Coordination Board, the

European Chemicals Agency (ECHA) and the European Food Safety

Authority (EFSA).

3. Where a competent authority of a Member State, after having performed an

evaluation in accordance with Article 89, considers that a product that is CE

marked in accordance with Article 18, does not fall within the scope of this

Regulation, it shall consult the competent authorities of the other Member

States regarding its envisaged measure determining the regulatory status of the

product in question.

4. Where a competent authority of a Member State raises a substantiated

disagreement regarding the envisaged measure referred to in paragraph 3, the

consulting authority shall refer the matter to an expert panel as referred to in

Article 106 of Regulation (EU) 2017/745 and shall give utmost consideration

to the opinion of that expert panel.

5. The results of the coordination activities of the competent authorities in

accordance with this Article and the opinions of the expert panel delivered in

accordance with paragraph 4 of this Article and Article 3a(2) shall be made

publicly available, without disclosing any confidential information as referred

to in Article 102.

6. The Commission may, by means of implementing acts, lay down the

procedure, including timelines, for the application of paragraphs 1 to 4 of this

Article and of Article 3a. Those implementing acts shall be adopted in

accordance with the examination procedure referred to in Article 107(3).’;

(4) the following Article 3a is inserted:

‘Article 3a

Opinion on and determination of the regulatory status of products at Union level

1. A competent authority, a notified body, a manufacturer, a developer of a

product or the Commission may submit a substantiated request for an opinion

from an expert panel referred to in Article 106 of Regulation (EU) 2017/745 on

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the question whether a specific product, or category or group of products, falls

within the definitions of ‘in vitro diagnostic medical device’ or ‘accessory for

an in vitro diagnostic medical device’. Where, in such a request, the requester

considers that the product in question is an in vitro diagnostic medical device,

the request shall also specify the proposed classification of the device in

accordance with Article 47 and Annex VIII.

2. The expert panel shall provide its opinion without undue delay. The requester

shall give utmost consideration to the opinion of the expert panel.

3. Having regard to the expert panel opinion referred to in paragraph 2 or in

Article 3(4), a Member State may submit a substantiated request to the

Commission to determine whether a specific product, or category or group of

products, falls within the definition of ‘in vitro diagnostic medical device’ or of

‘accessory for an in vitro diagnostic medical device’.

The Commission shall decide on the substantiated request of the Member State,

or on its own initiative, by means of implementing acts, which shall be adopted

in accordance with the examination procedure referred to in Article 107(3).

The Commission may ask the expert panel for clarifications or refer the

opinion back to the expert panel for further consideration, including in cases

where a Member State's substantiated request raises new questions of a

scientific or technical nature.

4. This Article shall not apply where within the framework of another Union

legislation the regulatory status of the product, or category or group of products

concerned has been determined as falling within the scope of that other Union

legislation, or where a procedure for the determination of the regulatory status

is ongoing within the framework of another Union legislation.’;

(5) Article 5 is amended as follows:

(a) paragraph 5 is amended as follows:

(i) the first subparagraph is amended as follows:

(1) point (a) is replaced by the following:

‘(a) the devices are not transferred to another legal entity, except

to another health institution in the duly justified interest of

public health, patient safety or patient health, or to prepare or

respond to a public health emergency;’;

(2) point (c) is replaced by the following:

‘(c) the laboratory of the health institution is compliant with

standard EN ISO 15189 or, where applicable, national

provisions for quality and competence in medical

laboratories, including national provisions regarding

accreditation;’;

(3) point (d) is deleted;

(4) point (e) is replaced by the following:

‘(e) upon request by a competent authority, the health institution

provides information on the use of such devices to its

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competent authority, which shall include the justification

referred to in point (a);’;

(5) point (f)(iii) is replaced by the following:

‘(iii) a declaration either that the health institution is accredited to

the standard referred to in point (c) or that the devices meet

the relevant general safety and performance requirements set

out in Annex I and, where applicable, information on which

requirements are not fully met with a reasoned justification

therefor;’;

(6) point (g) is replaced by the following:

‘(g) as regards class D devices in accordance with the rules set out

in Annex VIII, where the health institution is not accredited

to the standard referred to in point (c), the health institution

draws up documentation sufficiently detailed to enable the

competent authority to ascertain that the relevant general

safety and performance requirements set out in Annex I are

met;’;

(7) point (h) is deleted;

(ii) in the second subparagraph, the first sentence is deleted;

(iii) the following subparagraphs are added:

‘For the purposes of the first subparagraph, point (a), in the case of a

transfer of the device to another health institution, the transferring and

receiving health institutions shall ensure traceability of the device.

For the purposes of the first subparagraph, point (i), where the device is

transferred in accordance with the first subparagraph, point (a), the

receiving health institution shall report any incident related to the device

to the transferring health institution.

This paragraph shall also apply to devices manufactured and used within

a laboratory that is established in the Union and provides consistent, state

of the art testing services for clinical research, provided those devices are

intended exclusively for use in the framework of a clinical trial subject to

Regulation (EU) No 536/2014 of the European Parliament and of the

Council*. Where, in this paragraph, reference is made to a health

institution, such reference shall also be understood as reference to a

laboratory referred to in the first sentence of this subparagraph.

__________________

*Regulation (EU) No 536/2014 of the European Parliament and of the

Council of 16 April 2014 on clinical trials on medicinal products for

human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p.

1, ELI: http://data.europa.eu/eli/reg/2014/536/oj).’;

(b) the following paragraph 7 is added:

‘7. The Commission is empowered to adopt delegated acts in accordance

with Article 108, to amend the general safety and performance

requirements set out in Annex I in order to adapt them to scientific or

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technical progress or to international developments, or to add

requirements in relation to emerging risks or technologies.

8. When adopting implementing acts pursuant to paragraph 6 of this Article,

delegated acts pursuant to paragraph 7 of this Article or Common

Specifications pursuant to Article 9 of this Regulation concerning devices

that are high-risk AI systems as referred to in Article 6(1) of Regulation

(EU) 2024/1689 of the European Parliament and of the Council**, or that

use high-risk AI systems as safety components, the Commission shall

take into account the requirements set out in Chapter III, Section 2, of

that Regulation.

__________________

** Regulation (EU) 2024/1689 of the European Parliament and of the Council

of 13 June 2024 laying down harmonised rules on artificial intelligence

and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU)

No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and

Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial

Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI:

http://data.europa.eu/eli/reg/2024/1689/oj).’;

(6) Article 6 is amended as follows:

(a) the following paragraph 2a is inserted:

‘2a. Any natural or legal person offering a device in accordance with

paragraph 1 or a service in accordance with paragraph 2 shall provide in

the offer at least the information referred to in Section 20.2., points (a) to

(e) and (m), of Annex I and access to the instructions for use.’;

(b) paragraphs 3 and 4 are replaced by the following:

‘3. Upon request by a competent authority, any natural or legal person

offering a device in accordance with paragraph 1 or a service in

accordance with paragraph 2 shall make available a copy of the EU

declaration of conformity drawn up in accordance with Article 17 for the

device concerned and cooperate with the competent authorities of the

Member State in which the device or the service is offered.

4. A Member State may, on grounds of protection of public health, require a

provider of a service, as defined Article 1(1), point (b), of Directive (EU)

2015/1535, or the provider of the service referred to in paragraph 2, to

cease its activity.’;

(7) in Article 7, the following subparagraph is added:

‘Without prejudice to national law regarding the exercise of the medical profession,

the first subparagraph shall also apply to devices used for the provision of a service

referred to in Article 6(2).’;

(8) in Article 9(1), the first sentence is replaced by the following:

‘Where no harmonised standards exist or where relevant harmonised standards are

not sufficient, or where there is a need to address public health concerns, the

Commission, after having consulted the MDCG, may, by means of implementing

acts, adopt common specifications (CS) in respect of the requirements set out in this

Regulation, in particular the reports and plans to be drawn up by manufacturers, the

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general safety and performance requirements set out in Annex I, the technical

documentation set out in Annexes II and III, the conformity assessment procedures

set out in Annexes IX, X and XI, the performance evaluation and PMPF set out in

Annex XIII or the requirements regarding performance studies set out in Annexes

XIII and XIV.’;

(9) Article 10 is amended as follows:

(a) paragraphs 3 and 6 are deleted;

(b) paragraph 8 is amended as follows:

(i) in the first subparagraph, the first sentence is replaced by the following:

‘Manufacturers shall put in place an appropriate quality management

system to ensure that procedures are in place to keep series production in

conformity with the requirements of this Regulation.’;

(ii) the third subparagraph is deleted;

(c) paragraph 9 is deleted;

(d) paragraph 10 is amended as follows:

(i) in the first subparagraph, the following sentence is added:

‘When determining the official language of the Union in which the

information set out in Section 20 of Annex I or other information to be

provided by the manufacturer shall be made available, Member States

shall consider accepting another official language of the Union in which

the information is made available, taking into consideration the technical

knowledge, experience, education or training of the average intended

user(s).’;

(ii) the second subparagraph is deleted;

(e) paragraph 12 is deleted;

(f) in paragraph 13, the third and fourth subparagraphs are deleted;

(g) paragraph 14 is replaced by the following:

‘14. Where manufacturers have their devices designed and manufactured by

another legal or natural person the information on the identity of that person

shall be part of the information to be submitted in accordance with Article

26(3). In those cases, the manufacturer shall ensure that the relevant parts of

the technical documentation are drawn up, kept up to date and, upon request,

made available to the competent authorities in accordance with paragraphs 4

and 7 by the legal or natural person that has designed and manufactured the

device. In addition, the manufacturer shall draw up, keep up to date and, upon

request, make available to the competent authorities the remaining parts of the

technical documentation, in particular those referred to in Section 2 of Annex

II and in Annex III.’;

(h) paragraph 15 is deleted;

(10) Article 10a is amended as follows:

(a) in paragraph 1, second subparagraph, the first sentence is replaced by the

following:

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‘The information referred to in the first subparagraph shall be provided at least

six months before the anticipated interruption or discontinuation or, if this is

not possible, without undue delay after the manufacturer becomes aware of the

anticipated interruption or discontinuation.’;

(b) the following paragraphs 4, 5 and 6 are added:

‘4. The Commission, where necessary in cooperation with the EMA, shall

set up, maintain, and manage an IT system to facilitate the reporting and

information exchange regarding cases of interruption or discontinuation

of the supply of devices in accordance with paragraphs 1, 2 and 3. That

IT system shall be integrated in or interoperable with the European

database on medical devices referred to in Article 30. It shall also enable

health institutions and healthcare professionals to inform competent

authorities about the unavailability or the immediate risk of unavailability

of devices needed for the exercise of their professional activity.

5. The EMA, in collaboration with the Executive Steering Group on

Shortages of Medical Devices (MDSSG) established by Article 21 of

Regulation (EU) 2022/123 of the European Parliament and of the

Council***, shall develop a methodology to identify the devices, or

categories of devices, for which it is reasonably foreseeable that an

interruption or discontinuation of supply could result in serious harm or

a risk of serious harm to patients or public health as referred to in

paragraph 1. Based on that methodology, the EMA, in collaboration with

the MDSSG and in agreement with the Commission shall draw up,

publish and keep up to date a list of devices, or categories of devices, to

which paragraphs 1, 2 and 3 shall apply. For the purpose of this

paragraph, the MDCG, representatives of manufacturers, other relevant

actors in the supply chain for the medical device sector and

representatives of healthcare professionals, of patients and of consumers

may be consulted as necessary.

6. The competent authorities of the Member States or the Commission may

request the manufacturers of devices included in the list drawn up in

accordance with paragraph 5 to provide all necessary information

regarding risks and weaknesses within the supply chain which may affect

the supply of such devices, including production capacity and volume of

sales.

_______________________________

*** Regulation (EU) 2022/123 of the European Parliament and of the

Council of 25 January 2022 on a reinforced role for the European

Medicines Agency in crisis preparedness and management for medicinal

products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI:

http://data.europa.eu/eli/reg/2022/123/oj).’;

(11) in Article 11, paragraphs 4 and 5 are deleted;

(12) in Article 14, paragraph 2 is amended as follows:

(a) in the first subparagraph, point (d) is replaced by the following:

‘(d) that, where applicable, a UDI has been assigned by the manufacturer in

accordance with Article 24(3).’;

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(b) the second subparagraph is replaced by the following:

‘In order to meet the requirements referred to in the first subparagraph the

distributor may apply a sampling method that is representative of the devices

supplied by that distributor.’;

(13) Article 15 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. Manufacturers shall have available within their organisation at least one

person responsible for regulatory compliance who possesses the requisite

expertise in the field of in vitro diagnostic medical devices.’;

(b) paragraph 2 is replaced by the following:

‘2. Micro and small enterprises within the meaning of Commission

Recommendation 2003/361/EC**** shall not be required to have the

person responsible for regulatory compliance within their organisation

but shall have such person at their disposal.

______________

**** Commission Recommendation of 6 May 2003 concerning the definition

of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p.

36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).’;

(c) in paragraph 3, point (c) is replaced by the following:

‘(c) the post-market surveillance obligations are complied with in accordance

with Article 78;’;

(d) paragraph 6 is replaced by the following:

‘6. Authorised representatives shall have permanently and continuously at

their disposal at least one person responsible for regulatory compliance

who possesses the requisite expertise regarding the regulatory

requirements for in vitro diagnostic medical devices in the Union.’;

(14) Article 16 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) in the first subparagraph, the introductory wording is replaced by the

following:

‘A distributor, an importer or another natural or legal person who places

a product on the market or puts it into service shall assume the

obligations incumbent on manufacturers if it does any of the following:’

(ii) the second subparagraph is replaced by the following:

‘The first subparagraph shall not apply to any healthcare professional or

any other person who, while not considered a manufacturer, assembles or

adapts for an individual patient a device already on the market without

changing its intended purpose.’;

(b) paragraph 4 is deleted;

(15) Article 17 is amended as follows:

(a) in paragraph 1, the first sentence is replaced by the following:

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‘The EU declaration of conformity shall state that the requirements specified in

this Regulation have been fulfilled in relation to the device that is covered by

that declaration.’;

(b) the following paragraph 2a is inserted:

‘2a. Declarations of conformity in accordance with paragraphs 1 and 2 may

be provided in electronic form.’;

(16) The following Article 19a is inserted:

‘Article 19a

Kits

A kit may contain the following components:

(a) in vitro diagnostic medical devices or their accessories which may or may not

individually bear the CE marking in conformity with this Regulation;

(b) medical devices or their accessories bearing the CE marking in conformity

with Regulation (EU) 2017/745;

(c) other products which are used within the in vitro diagnostic examination or the

presence of which in the kit is otherwise justified, and where those products are

in conformity with the Union legislation that applies to them.’

(17) the heading of Chapter III is replaced by the following:

‘IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF

DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND

PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES’;

(18) Article 24 is amended as follows:

(a) in paragraph 1, the following point (ba) is inserted:

‘(ba) a Basic UDI-DI, as defined in Part C of Annex VI;’;

(b) paragraph 2 is amended as follows:

(i) point (d) is replaced by the following:

‘(d) the entity gives access to its system for the assignment of UDIs to

all interested users in accordance with a set of predetermined and

transparent terms and conditions taking into consideration the

interests of micro, small and medium-sized enterprises within the

meaning of Recommendation 2003/361/EC;’;

(ii) in point (e), the following subpoint (iv) is added:

‘(iv) offers its system for the assignment of UDIs to manufacturers that

are micro and small enterprises within the meaning of

Recommendation 2003/361/EC under preferential conditions that

take into account the specific needs of such enterprises and are

proportionate to their size.’;

(c) paragraph 3 is replaced by the following:

‘3. Before placing a device, other than a device for performance study, on

the market, the manufacturer shall, in accordance with the rules of the

issuing entity designated by the Commission in accordance with

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paragraph 2, assign to the device, a Basic UDI-DI and UDI as defined in

Part C of Annex VI. If applicable, the manufacturer shall assign a UDI-

DI to all higher levels of packaging.’;

(d) the following paragraph 3a is inserted:

‘3a. For devices that are the subject of a conformity assessment as referred to

in Article 48(3) and (4), Article 48(7), second subparagraph, Article

48(8), and Article 48(9), second subparagraph, the assignment of a Basic

UDI-DI referred to in paragraph 1 of this Article shall be done before the

manufacturer applies to a notified body for that assessment.’;

(e) in paragraph 10, points (a) and (b)are replaced by the following:

‘(a) amending the list of information set out in Parts A and B of Annex VI in

the light of technical progress; and

(b) amending Annex VI in the light of experience obtained from the

implementation of the UDI system, or international developments and

technical progress in the field of Unique Device Identification.’;

(19) Article 26 is replaced by the following:

‘Article 26

Registration of devices

1. Before placing a device, other than a device for performance study, on the

market, the manufacturer shall provide the Basic UDI-DI to the UDI database

together with the other core data elements referred to in Part B of Annex VI

related to that device, as applicable. The manufacturer shall keep up to date the

information provided to the UDI database.

2. For devices that are the subject of a conformity assessment as referred to in

Article 48(3) and (4), Article 48(7), second subparagraph, Article 48(8), and

Article 48(9), second subparagraph, the notified body shall confirm in

Eudamed that the information referred to in Part B of Annex VI is correct.’;

(20) in Article 27(2), the following sentence is added:

‘Where national distributor databases require information on devices, such databases

shall allow for the retrieval of the device information from the electronic systems

referred to in Article 30(2), points (a) and (b).’;

(21) Article 28 is amended as follows:

(a) the title is replaced by the following:

‘Registration of economic operators’;

(b) paragraphs 1 and 2 are replaced by the following:

‘1. Before placing a device on the market, manufacturers, authorised

representatives and importers shall, in order to register, submit to the

electronic system referred to in Article 27 the information referred to in

Part A of Annex VI, provided that they have not already registered in

accordance with this Article. In cases where the conformity assessment

procedure requires the involvement of a notified body pursuant to Article

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48, the information referred to in Part A of Annex VI shall be provided to

that electronic system before applying to the notified body.

2. Without undue delay, the competent authority shall verify the data

entered pursuant to paragraph 1, obtain a single registration number

(‘SRN’) from the electronic system referred to in Article 27 and issue it

to the manufacturer, the authorised representative or the importer’;

(c) in paragraph 4, the words ‘one week’ are replaced by the words ‘two weeks’;

(d) paragraph 6 is deleted;

(e) paragraph 7 is replaced by the following:

‘7. The data entered pursuant to paragraph 1 of this Article in the electronic

system referred to in Article 27 shall be accessible to the public, except

for details regarding the person responsible for regulatory compliance

referred to in Part A, point 1.4 of Annex VI.’;

(22) Article 29 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. For companion diagnostics, class C devices for self-testing and class D

devices, other than devices for performance studies, the manufacturer

shall draw up a summary of safety and performance.

The summary of safety and performance shall be written in a way that is

clear to the intended user.

The draft of the summary of safety and performance shall be part of the

documentation to be submitted to the notified body involved in the

conformity assessment pursuant to Article 48. The manufacturer shall

ensure that the summary of safety and performance is available to the

public in Eudamed and shall mention on the label or instructions for use

where the summary is available. ’;

(b) paragraph 2 is amended as follows:

(i) point (a) is replaced by the following:

‘(a) the identification of the device and the manufacturer, including the

Basic UDI-DI and, if already issued, the SRN, and a reference to

the location of the instructions for use in Eudamed;’;

(ii) points (b), (f), (g) and (h) are deleted;

(23) in Article 30(2), the following subparagraph is added:

‘By way of derogation from the first subparagraph, the Commission may decide that

one or more of the electronic systems referred to in that subparagraph are not to be

included in Eudamed. In that case, the Commission shall ensure that the electronic

system is interoperable with Eudamed.’;

(24) Article 31 is replaced by the following:

‘Article 31

Application of Chapter IV of Regulation (EU) 2017/745

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Article 35 and Articles 37 to 50 of Regulation (EU) 2017/745 shall apply, mutatis

mutandis, to the following:

(a) the authorities responsible for notified bodies to be appointed by Member

States for the purpose of this Regulation and their exchange of experience;

(b) the conformity assessment bodies applying for designation under this

Regulation and the assessment of their applications;

(c) the nomination of experts for joint assessment and the funding of activities

related to the designation and monitoring of notified bodies;

(d) the designation and notification procedure regarding notified bodies under this

Regulation, their subsidiaries and subcontracting, and their identification

number;

(e) the language requirements;

(f) the monitoring of notified bodies;

(g) changes to the designation and notification of notified bodies and challenges to

their competence;

(h) the coordination of notified bodies;

(i) the access to notified bodies and fees.’;

(25) Article 32 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. Notified bodies shall fulfil the tasks for which they are designated in

accordance with this Regulation in the public interest. They shall satisfy

the organisational and general requirements and the quality management,

resource and process requirements, as set out in Annex VII, that are

necessary to fulfil those tasks in an effective, independent, diligent and

expeditious manner.

Notified bodies designated for conformity assessment activities relating

to devices that are high-risk AI systems as referred to in Article 6(1) of

Regulation (EU) 2024/1689, or that use high-risk AI systems as safety

components, shall also meet the requirements set out in Article 31(4), (5),

(10) and (11) of that Regulation.’;

(b) the following paragraph 4 is added:

‘4. The Commission is empowered to adopt delegated acts in accordance

with Article 108 to amend Annex VII in order to adapt to technical and

scientific progress regarding conformity assessment in the field of in

vitro diagnostic medical devices, including developments at international

level.’;

(26) Articles 33 to 46 are deleted;

(27) Article 47 is amended as follows:

(a) paragraph 2 is replaced by the following:

‘2. The competent authorities shall coordinate their activities when

determining the classification of a device, or a category or group of

devices. The results of the coordination activities of the competent

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authorities, including the result of any decision or measure adopted by a

competent authority in accordance with Article 47a or 47b and any

opinion issued by an expert panel in relation to classification shall be

made publicly available, without disclosing any confidential information

as referred to in Article 102.’;

(b) in paragraph 3, point (b), is replaced by the following :

‘(b) that a device, or category or group of devices, shall for reasons of public

health based on new scientific evidence, or based on any information

which becomes available in the course of the vigilance and market

surveillance activities be reclassified, by way of derogation from Annex

VIII, taking into consideration the principle of proportionality and

classification of devices at international level.’;

(c) paragraph 5 is replaced by the following:

‘5. In order to ensure the uniform application of the rules set out in Annex

VIII, and taking account of the relevant scientific opinions of the relevant

scientific committees or expert panels, the Commission may adopt

implementing acts to the extent necessary to resolve issues of divergent

interpretation and of practical application.’;

(d) the following paragraph 7 is added:

‘7. The Commission is empowered to adopt delegated acts in accordance

with Article 108 to amend Annex VIII in order to adapt it to technical or

scientific progress or to take into account developments regarding

classification of devices at international level.’;

(28) the following Articles 47a and 47b are inserted:

‘Article 47a

Classification in the event of a dispute between manufacturer and notified body

1. A manufacturer or a notified body may refer any dispute between them arising

from the application of Annex VIII to the competent authority of the Member

State in which the manufacturer has its registered place of business. In cases

where the manufacturer has no registered place of business in the Union and

has not yet designated an authorised representative, the matter shall be referred

to the competent authority of the Member State in which the authorised

representative referred to in Section 2.2., second paragraph, point (b), last

indent, of Annex IX has its registered place of business.

The competent authority of the Member State in which the manufacturer has its

registered place of business shall notify the MDCG and the Commission of its

decision. The decision shall be made available upon request.

2. Within 30 days of receipt of the referral referred to in paragraph 1, the

competent authority shall consult the other Member States regarding its draft

classification decision.

3. Where, within 30 days of receipt of the consultation referred to in the

paragraph 2, no substantiated disagreement is raised by a Member State, the

competent authority shall adopt its decision within 90 days of receipt of the

referral referred to in paragraph 1.

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4. Where, within 30 days of receipt of the consultation referred to in paragraph 2,

a substantiated disagreement is raised by a Member State regarding the notified

envisaged decision on the classification, the matter shall be referred to an

expert panel as referred to in Article 106 of Regulation (EU) 2017/745. That

expert panel shall deliver an opinion on the classification of the device within

30 days. The competent authority may ask the expert panel for clarifications on

its opinion.

5. Within 30 days of receipt of the expert panel opinion, or any requested

clarification, the competent authority shall adopt its decision, giving utmost

consideration to the expert panel opinion. It shall notify the other Member

States and the Commission of its decision without undue delay.

6. The Commission may, by means of implementing acts, lay down further details

of the procedure for the application of this Article and of Article 47b. Those

implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 107(3).

Article 47b

Challenges to the classification of CE marked devices

1. Where a competent authority, after having performed an evaluation in

accordance with Article 89, considers that a device that is CE marked in

accordance with Article 18, is not classified in accordance with Annex VIII, it

shall consult the other Member States regarding its envisaged measure on the

classification of the device.

2. Where, within 30 days of receipt of the consultation referred to in paragraph 1,

no substantiated disagreement is raised by a Member State, the competent

authority may adopt the measure on the classification of the device in question

and shall notify the other Member States and the Commission of its decision

giving the reasons for the decision.

3. Where, within 30 days of receipt of the consultation referred to in paragraph 1,

a substantiated disagreement is raised by a Member State regarding the notified

envisaged measure on the classification, the matter shall be referred to an

expert panel referred to in Article 106 of Regulation (EU) 2017/745, which

shall deliver an opinion on the classification of the device within 30 days. The

competent authority may ask the expert panel for clarifications on its opinion.

4. The competent authority shall give utmost consideration to the expert panel

opinion. Where the competent authority adopts a measure on the classification,

it shall notify the other Member States and the Commission of its measure

without undue delay.’;

(29) Article 48 is amended as follows:

(a) in paragraph 3, the second and third subparagraphs are deleted;

(b) in paragraph 4, the second subparagraph is deleted;

(c) paragraphs 5 and 6 are deleted;

(d) paragraph 7 is replaced by the following:

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‘7. Manufacturers of class C devices, other than devices for performance

study, shall be subject to a conformity assessment as specified in

Chapters I and III of Annex IX.’;

(e) in paragraph 8, the second subparagraph is deleted;

(f) paragraph 9 is replaced by the following:

‘9. Manufacturers of class B devices, other than devices for performance

study, shall be subject to a conformity assessment as specified in

Chapters I and III of Annex IX.’;

(g) the following paragraph 9a is inserted:

‘9a. Manufacturers of class B devices, other than devices for performance

study, may, instead of the conformity assessment procedure referred to in

paragraph 9, choose to apply a conformity assessment as specified in

Annex X coupled with a conformity assessment as specified in Annex XI

with the exception of its Section 5.’;

(h) in paragraph 10, the second subparagraph is deleted;

(i) the following paragraphs 10a and 10b are inserted:

‘10a. In the case of devices for self-testing, in addition to the procedures

applicable pursuant to paragraph 3, 7 or 9, the procedure specified in

Section 5.1 of Annex IX shall also apply.

10b. In the case of companion diagnostics, in addition to the procedures

applicable pursuant to paragraph 3, 4, 7 or 8, the procedure specified in

Section 5.2 of Annex IX or in Section 3, point (k), of Annex X, as

applicable, shall also apply.’;

(j) paragraphs 12 and 13 are replaced by the following:

‘12. The documents relating to the procedures referred to in paragraphs 1 to 4

and 7 to 10b shall be available in any official language of the Union

acceptable to the notified body.

13. The Commission may, by means of implementing acts, specify the

detailed arrangements and procedural aspects of the conformity

assessment procedures with regard to any of the following aspects:

(a) in respect of class B and class C devices, the basis for the selection

of the representative device for the assessment of the technical

documentation as referred to in Section 2.3 of Annex IX;

(b) the modalities of unannounced on-site audits and sample tests to be

conducted by notified bodies in accordance with Section 3.4 of

Annex IX, taking into account the risk-class and the type of

device;

(c) the frequency of samples of the manufactured devices or batches of

class D devices to be sent to an EU reference laboratory designated

pursuant to Article 100, in accordance with Section 4.12 of Annex

IX and Section 5.1 of Annex XI;

(d) the physical, laboratory or other tests to be carried out by notified

bodies in the context of sample tests, assessment of technical

documentation and type;

EN 106 EN

(e) the modalities of the conformity assessment procedures regarding

breakthrough devices and orphan devices set out in Article 48a.

The implementing acts referred to in the first subparagraph shall be

adopted in accordance with the examination procedure referred to

in Article 107(3).’;

(k) the following paragraph 14 is added:

‘14. The Commission is empowered to adopt delegated acts in accordance

with Article 108 to amend Annexes IX, X and XI in order to adapt those

Annexes to technical or scientific progress or to developments regarding

conformity assessment of devices at international level and to take into

account the needs of particular devices in view of their special

characteristics.’;

(30) the following Articles 48a and 48b are inserted:

‘Article 48a

Conformity assessment of breakthrough devices and of orphan devices

1. For the conformity assessment of breakthrough devices and orphan devices, for

which a notified body is involved in the conformity assessment, the procedures

laid down in Article 48 shall apply subject to the specific arrangements set out

in this Article.

2. A device shall be considered a breakthrough device if it meets the following

criteria:

(a) the device is expected to introduce in the Union a high degree of novelty

with respect to the device technology or the related clinical procedure or

the application of the device in clinical practice;

(b) the device is expected to provide a significant positive clinical impact on

patient or public health, for a life-threatening or irreversibly debilitating

disease or condition, by either of the following: 

(i) offering a significant positive clinical or health impact compared to

available alternatives and the state of the art;

(ii) fulfilling an unmet medical need where there is an absence or

insufficiency of available alternative options for that purpose.

3. A device shall be considered an orphan device if it meets the following

criteria:

(a) the device is intended to provide information on a disease or condition

that presents in not more than 12 000 individuals in the Union per year;

(b) at least one of the following criteria is met:

(i) there are insufficient available alternatives;

(ii) the device is expected to provide a clinical benefit compared to

available alternatives or the state of the art.

4. Upon a duly substantiated request by a manufacturer or a notified body, an

expert panel as referred to in Article 106 of Regulation (EU) 2017/745 shall

provide an opinion as to whether the criteria set out in paragraph 2 or 3 of this

EN 107 EN

Article, as applicable, are fulfilled. That opinion shall be published on a

dedicated website without disclosing any confidential information as referred

to in Article 102 and shall be duly taken into consideration by the manufacturer

and the notified body.

5. Where the opinion of the expert panel confirms the fulfilment of the criteria set

out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough

device or of an orphan device, as applicable, may request advice from the

expert panels referred to in Article 106 of Regulation (EU) 2017/745 regarding

its performance evaluation strategy and appropriate analytical or clinical

performance data for the performance evaluation of the device.

6. For a confirmed breakthrough device or an orphan device, as applicable, the

notified body involved in the conformity assessment procedure set out in

Article 48 shall prioritise the conformity assessment and apply, where

appropriate, a rolling review with a view to reduce assessment timelines.

The notified body shall give due consideration to an opinion or advice provided

by the expert panel in accordance with paragraph 4 or 5 and, where it does not

follow such opinion or advice, it shall provide duly justified reasons. The

notified body may ask the expert panel to clarify the opinion it has provided.

7. The notified body shall issue a certificate pursuant to Article 51 where the pre-

market clinical evidence, even if based on limited clinical performance data, is

deemed adequate, provided that either of the following conditions is fulfilled:

(a) the benefit of the immediate availability on the market of the device

outweighs the risk associated with the fact that additional clinical

performance data are still required;

(b) the benefit-risk ratio of the device is favourable and the manufacturer

commits to providing additional data from post-market performance

follow-up activities.

Where appropriate, the notified body shall limit the validity of the certificate

and specify any conditions for or limitations to the certificate’s validity in

accordance with Article 51, such as specific post-market performance follow-

up activities to be conducted within a specified period of time.

8. The Commission is empowered to adopt delegated acts in accordance with

Article 108 in order to amend this Article to adapt to technical and scientific

progress and to take into account developments regarding conformity

assessment of breakthrough devices or orphan devices at international level.

9. The Commission may, by means of implementing acts, lay down further details

of the procedure for the conformity assessment of breakthrough devices or

orphan devices set out in this Article. Those implementing acts shall be

adopted in accordance with the examination procedure referred to in Article

107(3).

Article 48b

Digitalisation of technical documentation, conformity assessment and reports

1. The manufacturer may draw up and make available the technical

documentation and any reports or other documents required pursuant to this

EN 108 EN

Regulation in digital format, in particular structured machine-readable format,

provided that it is possible to transform it into human-readable format, and that

there is version-control to enable the conduct of retrospective conformity

checks. Where the technical documentation, reports or other documents are to

be submitted to and assessed by a notified body, the manufacturer shall agree

with the notified body on the digital format.

2. Where necessary to ensure that the digital format of the technical

documentation, reports or other documents is reliable, interoperable and

standardised, the Commission may, by means of CS as referred to in Article 9,

lay down minimum requirements or functional specifications for the digital

format.’;

(31) in Article 49, paragraph 5 of is replaced by the following:

‘5. Notified bodies and the personnel of notified bodies shall carry out their

conformity assessment activities in the public interest and with the highest

degree of professional integrity and the requisite technical and scientific

competence in the specific field and shall be free from all pressures and

inducements, particularly financial, which might influence their judgement or

the results of their conformity assessment activities, especially as regards

persons or groups with an interest in the results of those activities.’;

(32) Article 50 is replaced by the following:

‘Article 50

Mechanism for scrutiny of conformity assessments

1. The MDCG or the Commission may, based on reasonable concerns, request

advice from an expert panel in relation to the safety and performance of any

device. For that purpose, the MDCG or the Commission may request the

notified body that issued the certificate for the device in question to submit to

the expert panel its performance evaluation assessment report and any

subsequent surveillance assessment reports regarding that device. The expert

panel may request the notified body or the manufacturer to submit any

additional information needed for its assessment.

2. The MDCG or the Commission may, based on reasonable concerns, request

advice from one or more EU reference laboratories, on the basis of laboratory

testing, in relation to the safety and performance of any device, provided that

the device falls within the scope of designation of those EU reference

laboratories. For that purpose, the MDCG or the Commission may request the

notified body that issued the certificate for the device in question to submit to

the EU reference laboratories its performance evaluation assessment report and

any subsequent surveillance assessment reports regarding that device. The EU

reference laboratories may request the notified body or the manufacturer to

submit samples of the device or any additional information needed for their

assessment.

3. The notified body shall give utmost consideration to the advice of the expert

panel or the EU reference laboratory, as applicable, and, where needed, take

any appropriate measures, including those referred to in Article 51(3) and (4)’;

(33) Article 51 is amended as follows:

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(a) paragraphs 1 and 2 are replaced by the following:

‘1. The notified bodies shall issue certificates in accordance with Annexes

IX, X and XI in an official language of the Union and immediately

upload them in Eudamed. The minimum content of the certificates shall

be as set out in Annex XII.

‘2. The validity of certificates shall not be limited in time, unless in

exceptional cases where the notified body considers it necessary to limit

the period of validity based on duly justified grounds. In those cases, the

notified body shall indicate the period of validity on the certificate. If the

period of validity of the certificate is limited, on application by the

manufacturer, the notified body may, following an assessment performed

in accordance with Annex VII, Section 4.11, extend the validity of the

certificate. Any supplement to a certificate shall remain valid as long as

the certificate which it supplements is valid.’;

(b) the following paragraph 2a is inserted:

‘2a. During the validity of the certificate, the notified body shall carry out

appropriate surveillance activities, including periodic reviews taking into

consideration developments of the state of the art. Those reviews shall be

proportionate to the risk class of the device.’;

(c) paragraph 3 is replaced by the following:

‘3. Notified bodies may impose conditions on the certificate’s validity, such

as limiting the intended purpose of a device or requiring the manufacturer

to undertake specific PMPF studies pursuant to Part B of Annex XIII.’;

(d) in paragraph 4, the first sentence is replaced by the following:

‘Where a notified body finds that the requirements of this Regulation are no

longer met by the manufacturer, it shall, taking account of the principle of

proportionality, suspend or withdraw the certificate issued or impose any

conditions on it unless compliance with such requirements is ensured by

appropriate corrective action taken by the manufacturer within an appropriate

deadline set by the notified body.’;

(e) in paragraph 5, the first sentence is replaced by the following:

‘The notified body shall enter in the electronic system referred to in Article 52

any information regarding certificates issued, including amendments and

supplements thereto, and regarding suspended, reinstated, withdrawn or

refused certificates and conditions imposed on certificates.’;

(34) in Article 52, points (f) and (i) are deleted;

(35) Article 54 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. By way of derogation from Article 48, on a duly justified request, any

competent authority may authorise for a limited period of time the

placing on the market or putting into service within the territory of the

Member State concerned of a specific device for which the applicable

conformity assessment procedures have not been carried out, provided

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the use of that device is in the interest of public health, patient safety or

patient health.’;

(b) the following paragraph 1a is inserted:

‘1a. By way of derogation from Article 6(2) and on a duly justified request,

any competent authority may authorise for a limited period of time the

provision of a diagnostic or therapeutic service referred to in that Article

to a natural or legal person established within the territory of the Member

State concerned, using a device for which the applicable conformity

assessment procedures set out in this Regulation have not been carried

out, provided the provision of such service is in the interest of public

health, patient safety or patient health.’;

(c) paragraph 2 is replaced by the following:

‘2. The Member State shall inform the Commission, the other Member

States and the relevant expert panels referred to in Article 106 of

Regulation (EU) 2017/745 of any decision to authorise the placing on the

market or putting into service of a device, or the provision of a service, in

accordance with paragraph 1 or paragraph 1a of this Article, where such

authorisation is granted for use other than for a single patient.

The Member State shall make information about such authorisations

publicly available.’;

(d) in paragraph 3, the first subparagraph is replaced by the following:

‘Where a request pursuant to paragraph 1 or paragraph 1a has been submitted

to competent authorities in more than one Member State and based on an

opinion of an expert panel referred to in Article 106 of Regulation (EU)

2017/745, the Commission, in exceptional cases relating to public health,

patient safety or patient health, may, by means of implementing acts, extend

for a limited period of time the validity of an authorisation granted by a

Member State in accordance with paragraph 1 or paragraph 1a of this Article to

the territory of the Union, or provide an authorisation referred to in paragraph 1

or paragraph 1a of this Article for the territory of the Union. The Commission

may set the conditions under which the device may be placed on the market or

put into service, or under which the diagnostic or therapeutic service may be

provided. Those implementing acts shall be adopted in accordance with the

examination procedure referred to in Article 107(3).’;

(e) the following paragraphs 4 and 5 are added:

‘4. In the event of a public health emergency at Union level recognised in

accordance with Article 23 of Regulation (EU) 2022/2371 of the

European Parliament and of the Council*****, the Commission may, by

means of implementing acts, on its own initiative after consulting the

MDCG, authorise the placing on the market or putting into service of a

device in accordance with paragraph 3. The authorisation shall cease to

apply at the latest when the recognition of the public health emergency is

terminated pursuant to Article 23(2) of Regulation (EU) 2022/2371.

Those implementing acts shall be adopted in accordance with the

examination procedure referred to in Article 107(3). 

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On duly justified imperative grounds of urgency relating to the health and

safety of humans, the Commission shall adopt immediately applicable

implementing acts in accordance with the procedure referred to in

Article 107(4).

5. The Commission may, by means of implementing acts, lay down rules

further specifying the procedure set out in this Article. Those

implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 107(3).

____________________

***** Regulation (EU) 2022/2371 of the European Parliament and of the

Council of 23 November 2022 on serious cross-border threats to health

and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26,

ELI: http://data.europa.eu/eli/reg/2022/2371/oj).’;

(36) the following Articles 54a, 54b and 54c are inserted:

‘Article 54a

Derogations from certain requirements in the event of a serious cross-border threat to

health, disaster or crisis

1. Upon a duly justified request by a manufacturer, a competent authority may

authorise for a limited period of time, by way of derogation from the relevant

provisions in Annexes II, III, IX, X and XI, an exemption from the

requirements related to changes to the manufacturing, design or intended

purpose of a CE marked device, where it is in the interest of public health,

patient safety or patient health in either of the following circumstances:

(a) a serious cross-border threat to health as defined in Article 3, point (1) of

Regulation (EU) 2022/2371;

(b) a disaster or a crisis within the meaning of Regulation (EU) ../…. of the

European Parliament and of the Council******+.

2. The manufacturer shall ensure that the manufactured devices remain in

conformity with the relevant general safety and performance requirements set

out in Annex I.

3. The competent authority may request the notified body that issued a certificate

for the device in question to assist it in the assessment of the request referred to

in paragraph 1.

+ OJ: Please insert in the text the number of the Regulation contained in 2025/0223(COD) (Proposal for a

Regulation on the Union Civil Protection Mechanism and Union support for health emergency

preparedness and response, and repealing Decision No 1313/2013/EU) and insert the number, date, title

and OJ reference of that Regulation in the footnote.

EN 112 EN

4. Where applicable, the manufacturer shall keep the notified body that issued a

certificate for the device in question informed about any changes made

regarding the manufacturing, design or intended purpose of a CE marked

device in accordance with the authorisation referred to in paragraph 1.

5. Where a request pursuant to paragraph 1 has been submitted to competent

authorities in more than one Member State, the Commission, in exceptional

cases relating to public health, patient safety or patient health, may, by means

of implementing acts, extend for a limited period of time the validity of an

exemption granted by a Member State in accordance with paragraph 1 to the

territory of the Union, or provide an exemption referred to in paragraph 1 for

the territory of the Union. Those implementing acts shall be adopted in

accordance with the examination procedure referred to in Article 107(3). 

On duly justified imperative grounds of urgency relating to the health and

safety of humans, the Commission may adopt immediately applicable

implementing acts in accordance with the procedure referred to in

Article 107(4).

_______________

****** Regulation (EU) .../... of the European Parliament and of the Council of

... on ... (OJ ..., ELI ).

Article 54b

Regulatory sandboxes at national level

1. Member States, on their own initiative or upon a substantiated request by

manufacturer or a prospective manufacturer, may establish one or more

regulatory sandboxes to which the application of certain requirements of

Chapters V or VI or of Annexes I, VIII, IX, X, XI, XIII or XIV would not be

appropriate. The Member States shall designate the competent authority that is

responsible for the supervision of the regulatory sandbox.

Member States may also establish regulatory sandboxes jointly with other

Member States.

2. The activities within a regulatory sandbox shall take place pursuant to a

specific sandbox plan that clearly identify the requirements of this Regulation

referred to in paragraph 1, which are temporarily adapted or waived in the

regulatory sandbox, a justification that the application of those requirements is

not considered to be appropriate and an explanation as to how potential risks

related to the adaptation or waiver are to be controlled and mitigated. The plan

shall also identify the reasonable duration of the regulatory sandbox necessary

to achieve its objectives and the participants in the regulatory sandbox and their

respective roles.

3. A regulatory sandbox shall be set up only if the following conditions are met:

(a) the device is expected to address unmet medical needs or to provide a

significant clinical benefit to patients or to the health system compared

with similar existing alternatives or the state of the art;

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(b) the application of the requirements of this Regulation referred to in

paragraph 1 would impede or significantly delay the development of the

device and access by healthcare professionals or lay users to such device.

4. The Member State may request an expert panel referred to in Article 106 of

Regulation (EU) 2017/745 to provide scientific, technical or regulatory advice

on the design of the draft sandbox plan.

5. Any participant in the regulatory sandbox shall, without undue delay, inform

the competent authority that is responsible for the supervision of the regulatory

sandbox about any harm occurred in relation to the implementation of the

regulatory sandbox. The competent authority shall take immediate and

adequate corrective measures, including to suspend, revoke or restrict the scope

of the regulatory sandbox.

6. Manufacturers and prospective manufacturers participating in a regulatory

sandbox shall remain liable under applicable Union and national law for any

damage inflicted on third parties as a result of their activities taking place in the

regulatory sandbox.

7. The Member State shall inform the Commission and the MDCG about the

establishment of a regulatory sandbox and keep them informed about its

implementation and outcome.

Article 54c

Union regulatory sandboxes

1. The Commission, on its own initiative or upon a substantiated request by a

Member State, may establish by means of implementing acts for a limited time

and pursuant to a specific plan, Union regulatory sandboxes, which shall

inform whether the existing requirements appropriately regulate a specific type

of device with particular characteristics or emerging technologies, and there is

a risk that the existing requirements:

(a) would impede or significantly delay the development of such devices and

access by healthcare professionals or patients to those devices; or

(b) would not adequately protect the health and safety of patients, users or

other persons or other aspects of public health.

Union regulatory sandboxes shall not involve the placing on the market or

putting into service of devices which do not comply with this Regulation.

2. The Commission shall request an expert panel referred to in Article 106 of

Regulation (EU) 2017/745 to provide scientific, technical or regulatory advice

on the design of a Union regulatory sandbox.

3. The Commission shall inform the MDCG about the establishment of a

regulatory sandbox and keep it informed about its outcome.

4. The Commission may, by means of implementing acts, specify common

principles or the detailed arrangements for the establishment, operation and

supervision of regulatory sandboxes pursuant to Article 54b or of Union

regulatory sandboxes pursuant to this Article. Those implementing acts shall be

adopted in accordance with the examination procedure referred to in Article

107(3).

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5. The Commission is empowered to adopt delegated acts in accordance with

Article 108 to amend this Article or Article 54b in order to adapt to scientific,

technical or regulatory progress and to take into account developments

regarding regulatory sandboxes, including in areas other than in vitro

diagnostic medical devices.’;

(37) in Article 55, the following paragraph 1a is inserted:

‘1a. The competent authority of the Member State which issued the certificate of

free sale in accordance with paragraph 1 shall make that certificate publicly

available in Eudamed.’;

(38) Article 56 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. Manufacturers shall plan, conduct and document a performance

evaluation in accordance with this Article and with Part A of Annex XIII

to confirm the safety and performance of the device, in particular those

concerning the performance characteristics referred to in Chapter I and

Section 9 of Annex I, under normal conditions of use according to the

intended purpose of the device, and shall evaluate the acceptability of the

benefit-risk ratio referred to in Sections 1 and 8 of Annex I.

The performance evaluation shall follow a defined and methodologically

sound procedure for the demonstration of the following, in accordance

with this Article and with Part A of Annex XIII:

(a) scientific validity;

(b) analytical performance;

(c) clinical performance.

The data and conclusions drawn from the assessment of those elements

shall constitute sufficient clinical evidence for the device.

The manufacturer shall specify and justify the level of the clinical

evidence necessary to confirm the safety and performance of the device.

That level of clinical evidence shall be appropriate in view of the

characteristics of the device and its intended purpose.

The performance evaluation, its results and the clinical evidence derived

from it shall be documented in a performance evaluation report as

referred to in Section 1.3 of Annex XIII, which shall be part of the

technical documentation referred to in Annex II relating to the device

concerned.’;

(b) paragraphs 2 to 5 are deleted.

(c) paragraph 6 is replaced by the following:

‘6. The performance evaluation, its documentation and, where applicable

and needed, the summary of safety and performance referred to in Article

29 shall be updated throughout the life cycle of the device concerned

with data and findings obtained from implementation of the

manufacturer’s PMPF plan in accordance with Part B of Annex XIII and

the post-market surveillance plan referred to in Article 79, whenever

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those data and findings provide information relevant for the confirmation

of safety and performance of the device.’;

(d) the following paragraph 8 is added:

‘8. The Commission is empowered to adopt delegated acts in accordance

with Article 108 to amend Annex XIII in the light of technical and

scientific progress and developments at international level having due

regard to the protection of the health and safety of patients, users or other

persons and other aspects of public health.’;

(39) the following Article 56a is inserted:

‘Article 56a

Advice from expert panels

For class C and class D devices, a manufacturer may, prior to its performance study

or clinical performance evaluation, consult an expert panel as referred to in

Article 106 of Regulation (EU) 2017/745, with the aim of reviewing the

manufacturer’s intended strategy for demonstrating clinical performance or proposals

for any clinical performance study. The manufacturer and the notified body involved

in any future conformity assessment procedure shall, in the performance evaluation

report and the performance evaluation assessment report, give due consideration to

the advice of the expert panel, and where they do not follow that advice, they shall

provide duly justified reasons.’;

(40) Article 58 is amended as follows:

(a) in paragraph 1, point (a) is deleted;

(b) in paragraph 1, point (c) is replaced by the following:

‘(c) where the conduct of the study involves additional invasive procedures,

including high-risk procedures for collection of specimens, or other risks

for the subjects of the studies,’;

(c) paragraph 2 is deleted;

(d) in paragraph 5, point (a) is replaced by the following:

‘(a) the performance study is the subject of an authorisation by the Member

State(s) in which the specimens for the performance study are to be

collected, in accordance with this Regulation, unless otherwise stated;’;

(41) in Article 64(1), point (b) is replaced by the following:

‘(b) there are scientific grounds to expect that participation of the subject in the

performance study will have the potential to produce:

(i) a direct clinically relevant benefit for the subject resulting in a

measurable health-related improvement alleviating the suffering or

improving the health of the subject, or in the diagnosis of his or her

condition; or

(ii) a benefit for the population represented by the subject, provided that the

performance study poses only minimal risk to, and imposes minimal

burden on, the subject in comparison with the standard treatment of the

subject’s condition;’;

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(42) Article 66 is amended as follows:

(a) in paragraph 1, the first subparagraph is replaced by the following:

‘The sponsor of a performance study referred to in Article 58(1) and (2) shall

enter and submit an application to the Member State(s) in which the specimens

for the performance study are to be collected (referred to for the purposes of

this Article and Article 71 as ‘Member State concerned’) accompanied by the

documentation referred to in Sections 2 and 3 of Annex XIII and in

Annex XIV.’;

(b) paragraph 7 is replaced by the following:

‘7. The sponsor may start the performance study as soon as the Member

State concerned has notified the sponsor of its authorisation and provided

that a negative opinion which is valid for the entire Member State, under

national law, has not been issued by an ethics committee in the Member

State concerned in respect of the performance study. The Member State

shall notify the sponsor of the authorisation within 45 days of the

validation date of the application referred to in paragraph 5. The Member

State may extend this period by a further 20 days for the purpose of

consulting with experts.’;

(43) in Article 67, paragraph 2 is replaced by the following:

‘2. Member States shall ensure that the assessment is done jointly by an

appropriate number of persons who collectively have the necessary

qualifications and experience.’;

(44) in Article 68, the following paragraph 7 is added:

‘7. The processing of personal data in the context of a performance study,

including the secondary use of personal data initially collected for other

studies, shall be deemed to be carried out for scientific research purposes as

referred to in Article 9(2), point (j), of Regulation (EU) 2016/679 of the

European Parliament and of the Council *******.

_________________

*******Regulation (EU) 2016/679 of the European Parliament and of the Council of

27 April 2016 on the protection of natural persons with regard to the

processing of personal data and on the free movement of such data, and

repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119,

4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj).’;

(45) in Article 70(1), the second and third sentences are replaced by the following:

‘The sponsor shall include the documentation referred to in Part A, Section 2, of

Annex XIII and in Chapter I, Sections 1, 3 and 4, of Annex XIV. Article 58(5),

points (b) to (l) and (p), Article 71(1), Articles 72 and 73, and Article 76(5) and (6),

and the relevant provisions of Annexes XIII and XIV shall apply to PMPF studies

involving additional invasive or burdensome procedures.’;

(46) in Article 71, paragraphs 1 and 2, and paragraph 3, introductory wording and point

(a), are replaced by the following:

‘1. If a sponsor intends to introduce modifications to a performance study that are

likely to have a substantial impact on the safety, health or rights of the subjects

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or on the robustness or reliability of the data generated by the study, it shall

notify, by means of the electronic system referred to in Article 69, the Member

State(s) concerned of the reasons for and the nature of those modifications. The

sponsor shall include an updated version of the relevant documentation referred

to in Annex XIV as part of the notification. Changes to the relevant

documentation shall be clearly identifiable.

2. Where the performance study has been the subject of an authorisation in

accordance with Article 58(5), point (a), the Member State shall assess any

substantial modification to the performance study in accordance with the

procedure laid down in Article 67.

3. The sponsor may implement the modifications referred to in paragraph 1 if the

Member State concerned has notified the sponsor of its authorisation, or

without such authorisation at the earliest 38 days after the notification referred

to in paragraph 1, unless:

(a) the Member State concerned has notified the sponsor of its refusal based

on the grounds referred to in Article 67(4) or on considerations of public

health, of subject and user safety or health, or of public policy; or’;

(47) in Article 73(1), the first sentence is replaced by the following:

‘If the sponsor has temporarily halted a performance study or has terminated a

performance study early, it shall, within 15 days of the temporary halt or early

termination, inform the Member State in which that performance study has been

temporarily halted or terminated early, by means of the electronic system referred to

in Article 69, providing a justification.’;

(48) Article 74 is amended as follows:

(a) in paragraph 4, the second subparagraph is replaced by the following

‘The final assessment report shall be taken into account by all Member States

concerned when deciding on the sponsor's application in accordance with

paragraph 11’;

(b) in paragraph 5, the first and second sentence are replaced by the following:

‘Each Member State concerned may request, on a single occasion, additional

information from the sponsor. The sponsor shall submit the requested

additional information within 12 days of receipt of the request.’;

(c) in paragraph 6, the words ‘50 days’ are replaced by the words ‘20 days’;

(d) the following paragraph 15 is added:

‘15. The Commission is empowered to adopt delegated acts in accordance

with Article 108 to amend this Article in light of experience gained from

the practical application of the coordinated assessment procedure, in

particular as regards timelines and the authorisation of performance

studies subject to a coordinated assessment.’;

(49) Article 75 is deleted;

(50) the following Article 75a is inserted:

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‘Article 75a

Performance studies in combined studies

Performance studies that are part of combined studies, and which are subject to

authorisation in accordance with Article 58, may be carried out in accordance with

Article 14c of Regulation (EU) No 536/2014.

If the sponsor chooses to apply Article 14c of Regulation (EU) No 536/2014, the

requirements laid down therein and in any implementing and delegated acts adopted

in accordance with that Article shall apply in place of the corresponding

requirements laid down in this Regulation.’;

(51) in Article 78(4), the first sentence is replaced by the following:

‘If, in the course of the post-market surveillance, a need for preventive or corrective

action, or both, is identified, the manufacturer shall implement the appropriate

measures. The competent authorities concerned may request the manufacturer to

inform them when such action is taken to reduce a risk that may compromise the

safety or performance of the device.’;

(52) in Article 79, the second sentence is deleted;

(53) Article 81 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) in the first subparagraph, the first sentence is replaced by the following:

‘Manufacturers of class C and class D devices shall prepare a periodic

safety update report (‘PSUR’) for each device, or where relevant, for

each category or group of devices, summarising the results and

conclusions of the analyses of the post-market surveillance data gathered

as a result of the post-market surveillance plan referred to in Article 79,

together with a description of any preventive and corrective actions

taken, including their rationale.’;

(ii) the second subparagraph is replaced by the following:

‘Manufacturers of class C and class D devices shall update the PSUR in

the first year after the certificate is issued and every two years thereafter

or when there is a significant change in the benefit-risk determination or

in the acceptability of erroneous results. That PSUR shall be part of the

technical documentation specified in Annex III.’;

(b) paragraph 2 is replaced by the following:

‘2. For class D devices, the notified body shall review the PSUR during the

surveillance assessment. The manufacturer and notified body shall make

such PSURs and the evaluation by the notified body available to the

competent authorities through the electronic system referred to in Article

87.’;

(54) Article 82 is amended as follows:

(a) in paragraph 1, the second subparagraph is replaced by the following:

‘The reports referred to in the first subparagraph shall be submitted without

undue delay through the electronic system referred to in Article 87.’;

(b) paragraph 3 is replaced by the following:

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‘3. Manufacturers shall report any serious incident as referred to in

paragraph 1, first subparagraph, point (a), immediately after they have

established that there is a causal relationship between that incident and

their device or that such causal relationship is reasonably possible, and

not later than 30 days after they become aware of the incident.’;

(55) The following Article 82a is inserted:

‘Article 82a

Reporting of actively exploited vulnerabilities and severe incidents related to devices

1. Without prejudice to the reporting obligations regarding serious incidents and

field safety corrective actions set out in Article 82, the manufacturer of a

device shall report to the computer security incident response teams

(‘CSIRTs’), designated as coordinators of the Member States where a device

has been made available, and to the European Union Agency for Cybersecurity

(ENISA), either of the following:

(a) any actively exploited vulnerability as defined in Article 3, point (42), of

Regulation (EU) 2024/2847 of the European Parliament and of the

Council******** contained in the device;

(b) any severe incident as referred in Article 14(5) of Regulation (EU)

2024/2847 having an impact on the security of the device.

2. The manufacturer shall submit the report referred to in paragraph 1 through the

electronic system referred to in Article 87 not later than 30 days after it

becomes aware of the actively exploited vulnerability or the severe incident.

3. The report referred to in paragraph 1, as well as any report submitted by a

manufacturer in accordance with Article 82 that also qualifies as actively

exploited vulnerability or severe incident, shall be made available

simultaneously to the CSIRTs designated as coordinators of the Member States

in which the device has been made available and to ENISA

4. For the purposes of this Article, the CSIRTs designated as coordinators and

ENISA shall have access to Eudamed.

_____________

******** Regulation (EU) 2024/2847 of the European Parliament and of the

Council of 23 October 2024 on horizontal cybersecurity requirements for

products with digital elements and amending Regulations (EU) No 168/2013

and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ

L, 2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj).’;

(56) in Article 83(1), the first subparagraph is replaced by the following:

‘Manufacturers shall report by means of the electronic system referred to in Article

87 any statistically significant increase in the frequency or severity of incidents that

are not serious incidents, which could have a significant impact on the benefit-risk

analysis referred to in Sections 1 and 8 of Annex I or of any significant increase in

expected erroneous results established in comparison with the stated performance of

the device as referred to in Section 9.1, points (a) and (b), of Annex I and specified in

the technical documentation and product information.’;

(57) Article 84 is amended as follows:

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(a) in paragraph 1, the second subparagraph is replaced by the following:

‘The manufacturer shall cooperate with the competent authorities during the

investigations referred to in the first subparagraph and shall not perform any

investigation which involves altering the device or a sample of the batch

concerned in a way which may affect any subsequent evaluation of the causes

of the incident, prior to informing the competent authorities of such action.’;

(b) paragraph 2 is replaced by the following:

‘2. Member States shall take the necessary steps to ensure that any

information regarding a serious incident that has occurred within their

territory, or a field safety corrective action that has been or is to be

undertaken within their territory, and that is brought to their knowledge

in accordance with Article 82 is evaluated centrally at national level by

their competent authority, if possible together with the manufacturer.’;

(c) the following paragraph 3a is inserted:

‘3a. The competent authority may request the notified body that issued a

certificate in accordance with Article 51 for the device in question for

assistance in evaluating a corrective action related to a serious incident or

a field safety corrective action.’;

(d) paragraphs 6 and 7 are replaced by the following:

‘6. In the case of a companion diagnostic and where the manufacturer

confirms that the serious incident or field safety corrective action may

affect the safe and efficient use of the corresponding medicinal product,

the evaluating competent authority or the coordinating competent

authority referred to in paragraph 9 shall inform the national competent

authority or the EMA, which was consulted by the notified body in

accordance with the procedures set out in Section 5.2 of Annex IX and

Section 3, point (k), of Annex X.

7. If, after carrying out the evaluation in accordance with paragraph 3, the

evaluating competent authority identifies the need for additional

corrective actions from the manufacturer to minimise the risk of

recurrence of the serious incident, it shall, through the electronic system

referred to in Article 87, inform without delay the other competent

authorities of the corrective action taken or envisaged by the

manufacturer or required of it to minimise the risk of recurrence of the

serious incident, including information on the underlying serious

incidents and the outcome of its assessment.’;

(e) in paragraph 9, the introductory sentence is replaced by the following:

‘The competent authorities shall actively participate in a procedure in order to

coordinate their assessments referred to in paragraph 3 whenever such

coordination is needed to ensure a high level of protection of the health and

safety of patients, users and other persons or the protection of public health

throughout the Union, and in particular in the following cases:’;

(58) Article 86 is amended as follows:

(a) in the first subparagraph, the reference to ‘Articles 80 to 85 and 87’ is replaced

by ‘Articles 79 to 85 and 87’;

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(b) in the first subparagraph, point (b) is replaced by the following:

‘(b) the reporting of serious incidents and field safety corrective actions and

field safety notices, and the provision and content of the post-market

surveillance plan, periodic summary reports, post-market surveillance

reports, PSURs and trend reports by manufacturers as referred to in

Articles 79, 80, 81, 82, 83 and 84 respectively;’;

(59) in Article 87(2), second sentence, the reference to ‘Article 49’ is replaced by ‘Article

51’;

(60) Article 88 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. The competent authorities shall perform appropriate checks on the

conformity characteristics and performance of devices and on the

compliance of economic operators with the obligations set out in this

Regulation including, where appropriate, a review of documentation and

physical or laboratory checks on the basis of adequate samples. The

competent authorities shall, in particular, take account of established

principles regarding risk assessment and risk management, vigilance data

and complaints.’;

(b) the following paragraph 1a is inserted:

‘1a. Member States shall ensure that their national competent authorities are

provided with adequate and sufficient technical, financial and human

resources, and with infrastructure to fulfil their tasks effectively under

this Regulation.’;

(c) paragraph 2 is replaced by the following:

‘2. The competent authorities shall draw up annual surveillance activity

plans, taking into account the European market surveillance programme,

which shall be developed and maintained by the MDCG, and local

circumstances.’;

(d) the following paragraph 12 is added:

‘12. In respect of devices that are high-risk AI systems as referred to in

Article 6(1) of Regulation (EU) 2024/1689, the competent authorities

shall cooperate with market surveillance authorities of their Member

State designated in accordance with Article 70 of Regulation (EU)

2024/1689.’:

(61) Article 89 is replaced by the following:

‘Article 89

Evaluation of devices suspected of presenting an unacceptable risk or other non-

compliance

The competent authorities of a Member State, either alone or in cooperation with the

competent authorities of other Member States, shall carry out an evaluation of a

device or of an economic operator covering the relevant requirements laid down in

this Regulation relating to the risk presented by the device or to any other non-

compliance of the device or of the economic operator, where they, based on data

EN 122 EN

obtained by vigilance or market surveillance activities or on other information, have

reason to believe either of the following:

(a) a device may present an unacceptable risk to the health or safety of patients,

users or other persons, or to other aspects of the protection of public health;

(b) a device or an economic operator otherwise does not comply with the

requirements laid down in this Regulation.

The relevant economic operators and, where applicable and requested, the notified

body that issued a certificate for the device in question shall cooperate with the

competent authorities.’;

(62) Article 90 is amended as follows:

(a) paragraph 3 is replaced by the following:

‘3. The economic operators referred to in paragraph 1 shall, without delay,

ensure that all appropriate corrective action is taken within the period

referred to in that paragraph throughout the Union in respect of all the

devices concerned that they have made available on the market.’;

(b) paragraph 7 is amended as follows:

(i) the first sentence is replaced by the following:

‘Where, within two months of receipt of the notification referred to in

paragraph 4, no objection has been raised by either a Member State or the

Commission in respect of the notified measures taken by a Member

State, those measures shall be deemed to be justified.’;

(ii) the following subparagraph is added:

‘Paragraph 4 shall not apply to such measures adopted by the Member

States.’;

(63) Article 91 is amended as follows:

(a) in paragraph 1, the third sentence is deleted;

(b) in paragraph 2, the first subparagraph is replaced by the following:

‘Where the Commission considers the national measure to be justified as

referred to in paragraph 1 of this Article, Article 90(7), second sentence, shall

apply. If the Commission considers the national measure to be unjustified, the

Member State concerned, as well as any Member State that has taken

corresponding restrictive or prohibitive measures, shall withdraw the

measure.’;

(64) Article 92 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. Where, having performed an evaluation pursuant to Article 89, the

competent authorities of a Member State find that a device or an

economic operator does not comply with the requirements laid down in

this Regulation but does not present an unacceptable risk to the health or

safety of patients, users or other persons, or to other aspects of the

protection of public health, they shall require the relevant economic

operator to bring the non-compliance concerned to an end within a

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reasonable period that is clearly defined and communicated to the

economic operator and that is proportionate to the non-compliance.’;

(b) in paragraph 2, the first sentence is replaced by the following:

‘Where the economic operator does not bring the non-compliance to an end

within the period referred to in paragraph 1, the Member State concerned shall,

without delay, take all appropriate measures to restrict or prohibit the product

being made available on the market or to ensure that it is recalled or withdrawn

from the national market.’;

(c) the following paragraph 2a is inserted:

‘2a. The economic operator shall take any appropriate corrective action

pursuant to paragraph 1 or paragraph 2 throughout the Union in respect

of all the devices concerned that they have made available on the market,

unless a competent authority takes other appropriate measures.’;

(65) in Article 93(3), the fourth sentence is deleted;

(66) the heading of Chapter VIII is replaced by the following:

‘COOPERATION BETWEEN MEMBER STATES AND EU REFERENCE

LABORATORIES’;

(67) in Article 96, the first and second sentences are replaced by the following:

‘The Member States shall designate the competent authority or authorities

responsible for the implementation and practical application of this Regulation. They

shall ensure that those authorities are entrusted with sufficient powers, resources,

equipment and knowledge necessary for the effective and efficient performance of

their tasks pursuant to this Regulation’;

(68) in Article 97, paragraph 2 is deleted;

(69) Articles 98 and 99 are deleted;

(70) Article 100 is amended as follows:

(a) paragraph 2 is amended as follows:

(i) point (a) is replaced by the following:

‘(a) to verify the performance claimed by the manufacturer and the

compliance of class D devices with the applicable CS, when available, or

with other solutions chosen by the manufacturer to ensure a level of

safety and performance that is at least equivalent, as provided for in

Section 4.9 of Annex IX and in Section 3, point (j), of Annex X;’;

(ii) point (d) is replaced by the following:

‘(d) to provide scientific advice regarding the state of the art in relation

to specific devices, or a category or group of devices, where

requested on the basis of comparative test results or other studies’;

(iii) points (e) and (j) are deleted;

(iv) the following subparagraph is added:

‘The Commission is empowered to adopt delegated acts in accordance

with Article 108 to amend the first subparagraph by adding, adapting or

removing tasks from the list of tasks of the EU reference laboratories.’;

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(b) paragraph 3 is deleted;

(c) in paragraph 4, point (b) is replaced by the following:

‘(b) have at their disposal the necessary equipment and reference material to

carry out the tasks assigned to them’;

(d) in paragraph 5, point (j) is deleted;

(e) paragraph 7 is replaced by the following:

‘7. Where notified bodies or Member States request scientific or technical

assistance or a scientific opinion from an EU reference laboratory, they

may be required to pay fees to wholly or partially cover the costs

incurred by that laboratory in carrying out its tasks according to

predetermined and transparent terms and conditions.’;

(71) Article 101 is deleted;

(72) Article 103 is amended as follows:

(a) in paragraph 1, the reference to ‘Directive 95/46/EC’ is replaced by

‘Regulation (EU) 2016/679’;

(b) in paragraph 2, the reference to ‘Regulation (EC) No 45/2001’ is replaced by

‘Regulation (EU) 2018/1725 of the European Parliament and of the

Council*********.

______________________

********* Regulation (EU) 2018/1725 of the European Parliament and of the

Council of 23 October 2018 on the protection of natural persons with regard to

the processing of personal data by the Union institutions, bodies, offices and

agencies and on the free movement of such data, and repealing Regulation

(EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p.

39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj).’;

(73) the following Article 103a is inserted:

‘Article 103a

Submission of information or documents

The submission of information or documents in accordance with this Regulation

shall take place electronically. ’;

(74) Article 104 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. This Regulation shall be without prejudice to the possibility for Member

States and the Commision to levy fees for the activities set out in this

Regulation, provided that the level of the fees is set in a transparent

manner and on the basis of cost-recovery principles.’;

(b) in paragraph 2, second sentence, the words ‘on request’ are deleted;

(75) Article 105 is deleted;

(76) in Article 108(6), first and second sentences, the words ‘three months’ are replaced

by the words ‘two months’;

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(77) Article 109 is deleted;

(78) in Article 110, the following paragraphs 12 and 13 are added:

‘12. By way of derogation from Article 5 and from paragraphs 3 to 3e of this

Article, a device as referred to in paragraph 3a or paragraph 3b of this Article

that meets the criteria for an orphan device set out in Article 48a(3) may be

placed on the market or put into service beyond the dates referred to in

paragraphs 3a and 3b if the following conditions are met:

(a) an expert panel referred to in Article 106 of Regulation (EU) 2017/745

has issued an opinion confirming the fulfilment of the criteria for an

orphan device set out in Article 48a(3);

(b) there are no significant changes to the design and intended purpose of the

device;

(c) the device does not present an unacceptable risk to the health or safety of

patients, users or other persons, or to other aspects of the protection of

public health.

The requirements of this Regulation, with the exception of Chapters IV, V and

VI, shall apply to the device referred to in the first subparagraph. By way of

derogation from Article 81(1), manufacturers of class C and class D devices

placed on the market or put into service in accordance with this paragraph shall

update the PSUR at least annually. On an annual basis, the manufacturer shall

submit the PSUR and, where applicable, an update of the summary of safety

and performance to the competent authority of the Member State in which it is

established.

The competent authority of the Member State may require the manufacturer to

conduct defined post-market surveillance or PMPF activities within a specified

period of time to generate additional data to confirm the safety and

performance of the device and to evaluate the acceptability of the benefit-risk

ratio.

Devices placed on the market or put into service in accordance with this

paragraph, which do not have a valid certificate in accordance with paragraph

2, shall not bear the CE marking. In its EU declaration of conformity, the

manufacturer shall make reference to the fact that the device is an orphan

device placed on the market or put into service in accordance with this

paragraph.

The manufacturer shall inform the intended users that the device is an orphan

device placed on the market or put into service in accordance with this

paragraph, where applicable, in the summary of safety and performance and in

the instructions for use or any other accompanying documentation.

At least every 10 years, the manufacturer shall request an opinion from an

expert panel referred to in Article 106 of Regulation (EU) 2017/745 confirming

the fulfilment of the criteria for an orphan device set out in Article 48a(3) of

this Regulation.

13. As regards devices for which a conformity assessment procedure is pending on

…[OP please insert the date = six months after the date of entry into force of

this Regulation] or for which a certificate is issued by a notified body before

that date, the manufacturer and the notified body may agree to continue

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applying the provisions of this Regulation in the form applicable before …[OP

please insert the date = six months after the date of entry into force of this

Regulation] until the conformity assessment procedure is finalised or until the

certificate is renewed.’;

(79) Article 111 is amended as follows:

(a) in the first sentence, the date ‘27 May 2027’ is replaced by the date …‘[OP,

please insert the date = five years after the date of entry into force of this

Regulation]’;

(b) the second sentence is deleted;

(80) in Article 113(3), point (f), the following subparagraph is added:

‘After the date of application of the provisions referred to in the first subparagraph of

this point, where Member States maintain national databases, the relevant

information available in Eudamed for those national databases shall be retrieved

from Eudamed.’;

(81) Annexes I, II, III, VI, VII, IX, X, XI, XII, XIII, and XIV to Regulation (EU)

2017/746 are amended in accordance with Annex II to this Regulation.

Article 3

Amendments to Regulation (EU) 2022/123

Article 30 of Regulation (EU) 2022/123 is amended as follows:

(1) the first subparagraph is replaced by the following:

‘The Agency shall provide the secretariat for the expert panels designated in

accordance with Article 106(1) of Regulation (EU) 2017/745 (the ‘expert panels’)

and shall provide the support necessary to ensure that those expert panels can

efficiently perform the tasks set out in that Regulation and in Regulation (EU)

2017/746.’;

(2) the second subparagraph is amended as follows:

(a) the introductory wording is replaced by the following: ‘The Agency shall, in

particular,’:

(b) point (a) is replaced by the following:

‘(a) select and appoint the experts in accordance with Article 106(2) and (5)

of Regulation (EU) 2017/745 and provide administrative and technical

support to the expert panels for the provision of opinions and advice;’;

(c) points (c), (d) and (e) are replaced by the following:

‘(c) ensure that the work of the expert panels is carried out in an independent

manner in accordance with Article 106(3) and Article 107 of Regulation

(EU) 2017/745. For that purpose, the Agency shall establish systems and

procedures to actively manage and prevent potential conflicts of interest;

(d) maintain and regularly update a webpage for the expert panels and make

all necessary information not already publicly available in Eudamed

publicly available on that webpage;

EN 127 EN

(e) publish the opinions of the expert panels in accordance with Regulation

(EU) 2017/745 or Regulation (EU) 2017/746, while ensuring

confidentiality in accordance with Article 109 of Regulation (EU)

2017/745 or Article 102 of Regulation (EU) 2017/746;’;

(d) in point (f), the reference to ‘Article 106(14)’ is replaced by the reference to

‘Article 106(10)’;

(e) the following point (i) is added:

‘(i) submit to the Commission a substantiated recommendation for the fees to

be paid by manufacturers or notified bodies for the opinions or advice

provided by expert panels, as referred to in Article 106(9) and (10) of

Regulation (EU) 2017/745.’.

Article 4

Amendments to Regulation (EU) 2024/1689

Annex I to Regulation (EU) 2024/1689 is amended as follows:

(1) in Section A, points 11 and 12 are deleted;

(2) in Section B, the following points are added:

‘21. Regulation (EU) 2017/745 of the European Parliament and of the Council of

5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC)

No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives

90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p.1);

22. Regulation (EU) 2017/746 of the European Parliament and of the Council of

5 April 2017 on in vitro diagnostic medical devices and repealing Directive

98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).’.

Article 5

Entry into force and application

1. This Regulation shall enter into force on the twentieth day following that of its

publication in the Official Journal of the European Union.

2. It shall apply from …[OP please insert the date = six months after the date of entry

into force of this Regulation].

3. By way of derogation from paragraph 2:

(a) Article 1, points (47) and (95), Article 2, points (33), (40) and (78), Article 3

and Article 4 shall apply from …[OP please insert the date = the date of entry

into force of this Regulation];

(b) Article 1, points (27) to (40) and Article 2, points (24), (25) and (26), shall

apply from… [OP please insert the date = 12 months after the date of entry into

force of this Regulation];

(c) Article 1, point (69), and Article 2, point (55), shall apply from …[ OP please

insert the date = three years after date of entry into force of this Regulation];

(d) Article 1, point (15), shall apply from …[OP please insert the date = five years

after the date of entry into force of this Regulation].

EN 128 EN

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg,

For the European Parliament For the Council

The President The President

EN 1 EN

LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 3

1.1. Title of the proposal/initiative ...................................................................................... 3

1.2. Policy area(s) concerned .............................................................................................. 3

1.3. Objective(s) .................................................................................................................. 3

1.3.1. General objective(s) ..................................................................................................... 3

1.3.2. Specific objective(s) ..................................................................................................... 3

1.3.3. Expected result(s) and impact ...................................................................................... 3

1.3.4. Indicators of performance ............................................................................................ 3

1.4. The proposal/initiative relates to: ................................................................................. 4

1.5. Grounds for the proposal/initiative .............................................................................. 4

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative ............................................................ 4

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities). For

the purposes of this section 'added value of EU involvement' is the value resulting

from EU action, that is additional to the value that would have been otherwise

created by Member States alone. ................................................................................. 4

1.5.3. Lessons learned from similar experiences in the past .................................................. 4

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments ....................................................................................... 5

1.5.5. Assessment of the different available financing options, including scope for

redeployment ................................................................................................................ 5

1.6. Duration of the proposal/initiative and of its financial impact .................................... 6

1.7. Method(s) of budget implementation planned ............................................................. 6

2. MANAGEMENT MEASURES................................................................................... 8

2.1. Monitoring and reporting rules .................................................................................... 8

2.2. Management and control system(s) ............................................................................. 8

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed .................. 8

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them............................................................................................................ 8

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure) ........................................... 8

2.3. Measures to prevent fraud and irregularities ................................................................ 9

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 10

3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s)

affected ....................................................................................................................... 10

EN 2 EN

3.2. Estimated financial impact of the proposal on appropriations ................................... 12

3.2.1. Summary of estimated impact on operational appropriations.................................... 12

3.2.1.1. Appropriations from voted budget ............................................................................. 12

3.2.1.2. Appropriations from external assigned revenues ....................................................... 17

3.2.2. Estimated output funded from operational appropriations......................................... 22

3.2.3. Summary of estimated impact on administrative appropriations ............................... 24

3.2.3.1. Appropriations from voted budget .............................................................................. 24

3.2.3.2. Appropriations from external assigned revenues ....................................................... 24

3.2.3.3. Total appropriations ................................................................................................... 24

3.2.4. Estimated requirements of human resources.............................................................. 25

3.2.4.1. Financed from voted budget....................................................................................... 25

3.2.4.2. Financed from external assigned revenues ................................................................ 26

3.2.4.3. Total requirements of human resources ..................................................................... 26

3.2.5. Overview of estimated impact on digital technology-related investments ................ 28

3.2.6. Compatibility with the current multiannual financial framework.............................. 28

3.2.7. Third-party contributions ........................................................................................... 28

3.3. Estimated impact on revenue ..................................................................................... 29

4. DIGITAL DIMENSIONS .......................................................................................... 29

4.1. Requirements of digital relevance .............................................................................. 30

4.2. Data ............................................................................................................................ 30

4.3. Digital solutions ......................................................................................................... 31

4.4. Interoperability assessment ........................................................................................ 31

4.5. Measures to support digital implementation .............................................................. 32

EN 3 EN

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1. Title of the proposal/initiative

Proposal for a Regulation of the European Parliament and of the Council amending

Regulation (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing

the burden of the rules on medical devices and in vitro diagnostic medical devices,

and amending Regulation (EU) 2022/123 as regards the support of the European

Medicines Agency for the expert panels on medical devices and Regulation (EU)

2024/1689 as regards the list of Union harmonisation legislation referred to in its

Annex I

1.2. Policy area(s) concerned

Competitiveness, prosperity and security

1.3. Objective(s)

1.3.1. General objective(s)

Simplify the rules on medical devices and in vitro diagnostic medical devices, reduce

the administrative burden on manufacturers, and enhance the predictability and cost-

efficiency of the certification procedure by notified bodies, while preserving a high

level of public health protection and patient safety.

In doing so, these measures will support the growth and development of companies -

- boosting their competitiveness and their contribution to European welfare and

prosperity - and promote a more favorable business environment that reduces

administrative burdens and strengthens companies’ ability to innovate, create jobs,

and drive economic growth, fostering a high level of patients’ care.

1.3.2. Specific objective(s)

Specific objective 1: To increase the cost-effectiveness and overall competitiveness

of the EU medical devices and in vitro diagnostic medical devices industry by

supporting innovation (including through adaptive regulatory pathways for

breakthrough technologies, and through further digitalisation), while ensuring a high

level of protection of human health for patients and users.

Specific objective 2: To simplify and streamline certain requirements and

procedures for medical devices and in vitro diagnostic medical devices identified as

particularly burdensome and disproportionate, especially for low and medium risk

devices and for orphan devices.

Specific objective 3: Improve the coordination between national competent

authorities, Commission/EMA and Notified Bodies, i.e. the governance and

organisation of the EU regulatory system, and enable the EU medical devices sector

to benefit from international cooperation including reliance mechanisms.

EN 4 EN

1.3.3. Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.

The proposal aims to improve the functioning of the current regulatory framework, in

particular with regard to the smooth functioning of the internal market, while

ensuring a high level of health protection for patients.

It builds on the existing key features of the framework, notably the decentralised

approach with responsibilities allocated to the Member States and the involvement of

Notified Bodies in the conformity assessment procedure. The aim of this revision is

to ensure a leaner and more cost-effective regulatory framework and further

strengthen the existing level of harmonisation, creating a more competitive and

innovative EU market.

The impact of the current proposal is expected to materialise on several actors.

Manufacturers

• Benefit from increased legal clarity and certainty through clearer scope and

definitions, including published outcomes of classification disputes.

• Operate under a more flexible and proportionate framework for clinical

evaluation and clinical investigations (expert panel advice, proportionate

clinical updates, use of non-clinical data, clearer rules for vulnerable

populations).

• Face simplified and less burdensome classification and conformity assessment

procedures, supporting innovation (e.g. dedicated pathways for breakthrough

devices, regulatory sandboxes).

• Benefit from streamlined re-certification procedures and reduced associated

costs.

• Experience reduced administrative burden in post-market surveillance,

vigilance and market surveillance.

• Gain access to expert panels for early advice, improving predictability (with

some additional costs/time).

• SMEs benefit from more proportionate fees and tailored support schemes,

including support offered by the EMA.

Notified Bodies

• Benefit from improved legal clarity and certainty due to clearer scope and

definitions.

• Operate within a more efficient and predictable regulatory system.

• May experience adjustment of fee revenues due to simplified procedures, and a

more streamlined framework reducing complexity and administrative load.

EN 5 EN

Distributors

• Gain from clearer obligations and improved legal certainty.

• Benefit from more stable and reliable supply chains due to reduced risks of

device shortages.

• Face lower administrative burden thanks to streamlined procedures.

National Competent Authorities

• Gain from clearer scope, definitions and legal certainty.

• Benefit from simplified governance structures, reinforced coordination

mechanisms and international cooperation.

• Achieve more efficient oversight through clearer procedures.

Patients, users and healthcare systems

• Benefit from sustained availability of safe, high-quality and innovative devices.

• Increased availability of information on the regulatory process

• Experience reduced risks of shortages, securing continuity of care.

• Gain from improved public health outcomes due to safety, availability and

innovation.

1.3.4. Indicators of performance

– Sustained availability of critical devices (target: no shortages due to regulatory

causes) (measure availability and continuity of supply)

– Reduced time for conformity assessment

– Reduced administrative burden for manufacturers (target: measurable annual

reduction).

– Increased number of innovative devices entering the market

– Maintain the availability of orphan devices and devices intended for small size

populations.

– Stable or improved safety indicators (no increase in serious incidents).

– Improved predictability and consistency in regulatory decisions (e.g. number of

expert panel opinions).

– Higher SME participation in the EU medical device market (support to SMEs

for the use of the EU regulatory framework).

– Use of dedicated pathways for breakthrough devices (measure the support for

innovation)

– Participation in international cooperation mechanisms

EN 6 EN

1.4. The proposal/initiative relates to:

 a new action

 a new action following a pilot project / preparatory action52

the extension of an existing action

 a merger or redirection of one or more actions towards another/a new action

1.5. Grounds for the proposal/initiative

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative

The adoption of the Regulation by the co-legislators is expected for Q2 2027. It will

enter into force on 20th day following that of its publication in the OJEU.

Transitional periods are foreseen for those measures that require procedural or

technical adaptations by manufacturers to ensure a smooth transition to the modified

regulatory framework.

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities). For

the purposes of this section 'added value of EU involvement' is the value resulting

from EU action, that is additional to the value that would have been otherwise

created by Member States alone.

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in

vitro diagnostic medical devices aimed to establish a robust, transparent, predictable

and sustainable regulatory framework for medical and in vitro diagnostic devices,

ensuring a high level of safety and health whilst supporting innovation. They have

been applicable since 26 May 2021 and 26 May 2022 respectively.

However, the much more demanding requirements stemming from these

Regulations, including for existing devices, combined with the limited capacities of

notified bodies and the insufficient preparedness of manufacturers, have resulted in

the risk of shortages and even the disappearance of critical devices from the market.

In practice, these challenges have revealed that certain elements of the Regulations

themselves created structural obstacles that the system has been unable to absorb.

Consequently, the transitional periods have been repeatedly extended, yet these

extensions have provided only short-term relief and could not address the underlying

issues embedded in the current regulatory framework. To resolve these structural

problems and to achieve a streamlined, predictable and future-proof system,

coordinated action at EU level is required through this proposed act.

52 As referred to in Article 58(2), point (a) or (b) of the Financial Regulation.

EN 7 EN

1.5.3. Lessons learned from similar experiences in the past

This proposal stems from the results of the targeted evaluation.

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments

• The initiative will be fully financed via redeployments from programmes under

the 2028-2034 MFF.

• Strategic Projects that address a vulnerability in the supply chains of critical

medicinal devices will be deemed to contribute to the STEP objectives and

may benefit from facilitation of the financial support when granted the STEP

seal on the basis of Regulation (EU) 2024/795 establishing the Strategic

Technologies for Europe Platform (STEP).

1.5.5. Assessment of the different available financing options, including scope for

redeployment

n/a

EN 8 EN

1.6. Duration of the proposal/initiative and of its financial impact

 limited duration

–  in effect from [DD/MM]YYYY to [DD/MM]YYYY

–  financial impact from YYYY to YYYY for commitment appropriations and

from YYYY to YYYY for payment appropriations.

unlimited duration

– Implementation with a start-up period from YYYY to YYYY,

– followed by full-scale operation.

1.7. Method(s) of budget implementation planned53

 Direct management by the Commission

–  by its departments, including by its staff in the Union delegations;

–  by the executive agencies

 Shared management with the Member States

 Indirect management by entrusting budget implementation tasks to:

–  third countries or the bodies they have designated

–  international organisations and their agencies (to be specified)

–  the European Investment Bank and the European Investment Fund

–  bodies referred to in Articles 70 and 71 of the Financial Regulation

–  public law bodies

–  bodies governed by private law with a public service mission to the extent that

they are provided with adequate financial guarantees

–  bodies governed by the private law of a Member State that are entrusted with

the implementation of a public-private partnership and that are provided with

adequate financial guarantees

–  bodies or persons entrusted with the implementation of specific actions in the

common foreign and security policy pursuant to Title V of the Treaty on

European Union, and identified in the relevant basic act

– bodies established in a Member State, governed by the private law of a

Member State or Union law and eligible to be entrusted, in accordance with

53 Details of budget implementation methods and references to the Financial Regulation may be found on

the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-

implementation/Pages/implementation-methods.aspx.

EN 9 EN

sector-specific rules, with the implementation of Union funds or budgetary

guarantees, to the extent that such bodies are controlled by public law bodies or

by bodies governed by private law with a public service mission, and are provided

with adequate financial guarantees in the form of joint and several liability by the

controlling bodies or equivalent financial guarantees and which may be, for each

action, limited to the maximum amount of the Union support.

Comments

The budget will be implemented by the European Commission, by HaDEA and by the

European Medicines Agency (EMA).

EN 10 EN

2. MANAGEMENT MEASURES

2.1. Monitoring and reporting rules

All Union agencies work under a strict monitoring system involving an internal control

coordinator, the Internal Audit Service of the Commission, the Management Board, the

Commission, the Court of Auditors and the Budgetary Authority. This system is

reflected and laid down in the EMA’s founding regulation. In accordance with the Joint

Statement on the EU decentralised agencies (the ‘Common Approach’), the framework

financial regulation (2019/715) and related Commission Communication C(2020)2297,

the annual work programme and Single Programming Document of the Agency

comprise detailed objectives and expected results, including a set of performance

indicators. The Single Programming Document combines multiannual and annual

programming as well as “strategy documents”, e.g. on independence. DG SANTE

comments through the Agency’s Management Board and prepares a formal

Commission Opinion on the Single Programming Document. The activities of the

Agency will be measured against these indicators in the Consolidated Annual Activity

Report. The Agency will monitor periodically the performance of its internal control

system to ensure that data is collected efficiently, effectively and timely and to identify

internal control deficiencies, register and assess the results of controls, control

deviations and exceptions. The results of the internal control assessments, including

significant weaknesses identified and any differences as compared to internal and

external audit findings will be disclosed in the Consolidated Annual Activity report.

2.2. Management and control system(s)

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed

The annual EU subsidy will be transferred to the Agency in accordance with its

payment needs and upon its request. The Agency will be subject to administrative

controls including budgetary control, internal audit, annual reports by the European

Court of Auditors, the annual discharge for the execution of the EU budget and

possible investigations conducted by OLAF to ensure, in particular, that the resources

allocated to the Agency are put to proper use. Through its representation in the

Agency's Management Board and Audit Committee, the Commission will receive

audit reports and will ensure that adequate actions are defined and timely

implemented by the Agency to address the issues identified. All payments will

remain pre-financing payments until the Agency’s accounts have been audited by the

European Court of Auditors and the Agency has submitted its final accounts. If

necessary, the Commission will recover unspent amounts of the instalments paid to

the Agency. The activities of the Agency will also be subject to the supervision of the

Ombudsman in accordance with Article 228 of the Treaty. These administrative

controls provide a number of procedural safeguards to ensure that account is taken of

the interests of the stakeholders.

EN 11 EN

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them

The main risks relate to the Agency’s performance and independence in

implementing the tasks entrusted to it. Underperformance or impaired independence

could hamper the achievement of the objectives of this initiative and also reflect

negatively on the Commission’s reputation. The Commission and the Agency have

put in place internal procedures that aim at covering the risks identified above. The

internal procedures are in full compliance with the Financial Regulation and include

anti-fraud measures and cost-benefit considerations. First and foremost, sufficient

resources should be made available to the Agency in both financial and staffing

terms to achieve the objectives of this initiative. Furthermore, quality management

will include both the integrated quality-management activities and risk-management

activities within the Agency. A risk review is conducted annually, with risks being

assessed at a residual level, i.e. taking into account controls and mitigations already

in place. Conducting self-assessments (as part of the EU Agencies benchmarking

programme), annual reviews of sensitive functions and ex-post controls also fall

within this area, as does maintaining a register of exceptions. To preserve

impartiality and objectivity in every aspect of the Agency’s work, a number of

policies and rules on management of competing interests have been put in place and

will be regularly updated, describing specific arrangements, requirements and

processes applying to the Agency’s Management Board, scientific committee

members and experts, the Agency’s staff and candidates, as well as consultants and

contractors. The Commission will be informed in a timely manner of relevant

management and independence issues encountered by the Agency and will react

upon notified issues in a timely and adequate manner.

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure)

The Commission’s and the Agency’s internal control strategies take into

consideration the main cost drivers, and the efforts already taken over several years

to reduce the cost of controls, without compromising the effectiveness of controls.

The existing control systems proved to be able to prevent and/or to detect errors

and/or irregularities, and in case of errors or irregularities, to correct them. In the past

five years, the Commission’s yearly costs of controls under indirect management

represented less than 1% of the annual budget spent on subsidies paid to the Agency.

The Agency allocated less than 0,5% of its total annual budget on control activities

centering around integrated quality management, audit, anti-fraud measures, finance

and verification processes, corporate risk management and self-assessment activities.

EN 12 EN

2.3. Measures to prevent fraud and irregularities

As for its activities in indirect management, the Commission shall take appropriate

measures ensuring that the financial interests of the European Union are protected by

the application of preventive measures against fraud, corruption and any other illegal

activities, by effective checks and, if irregularities are detected, by the recovery of

the amounts wrongly paid and, where appropriate, by effective, proportional and

deterrent penalties. To this effect, the Commission adopted an anti-fraud strategy,

latest update of April 2019 (COM(2019)196)54, covering preventive, detective and

corrective measures. The Commission or its representatives and the European Court

of Auditors shall have the power of audit, on the basis of documents and on-the-spot,

over all grant beneficiaries, contractors and subcontractors who have received Union

funds. OLAF shall be authorised to carry out on-the-spot checks and inspections on

economic operators concerned indirectly by such funding. As regards the European

Medicines Agency, the anti-fraud measures are provided for in Article 69 of

Regulation (EC) No 726/2004 and the framework financial Regulation (2019/715).

The Executive Director and the Management Board of the Agency will take the

appropriate measures in accordance with the Internal Control Principles applied

across all EU institutions. In line with the Common Approach and Article 42 of the

framework financial Regulation, an anti-fraud strategy has been developed and is

followed by the Agency. The Agency’s Anti-fraud strategy covers 3-year period and

is accompanied by a corresponding action plan, outlining both specific focus areas

and actions for the next years, and several continuous actions that are carried out

every year, such as a specific standalone fraud risk assessment, with the identified

fraud risks included in the overall Agency risk register. Anti-fraud trainings are

organised as part of the induction training and via mandatory anti-fraud e-learning

training for newcomers. Staff are made aware of how to report any suspects of

wrongdoings and disciplinary procedures are in place as per the rules of the Staff

Regulations.

54 Commission Anti-Fraud Strategy: enhanced action to protect the EU budget.

EN 13 EN

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

3.1. Heading(s) of the multiannual financial framework and expenditure budget

line(s) affected

• Existing budget lines

In order of multiannual financial framework headings and budget lines.

Heading of

multiannual

financial

framework

Budget line Type of

expenditure Contribution

Number

Diff./Non-

diff.55

from

EFTA

countries 56

from

candidate

countries

and

potential

candidates 57

From

other

third

countries

other assigned

revenue

2 Operational expenditure Diff YES YES YES NO

2 Support expenditure Non-diff. YES YES YES NO

2 Union contribution to the European

Medicines Agency Non-diff. YES YES YES NO

4 Headquarters and Representation offices -

officials and temporary staff

Non-

diff. NO NO NO NO

4

External personnel – Headquarters and

Representation offices

Non-

diff. NO NO NO NO

4 Conference and meeting costs Non-

diff. NO NO NO NO

4 Missions, conferences and representation

expenses

Non-

diff. NO NO NO NO

55 Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 56 EFTA: European Free Trade Association. 57 Candidate countries and, where applicable, potential candidates from the Western Balkans.

EN 14 EN

3.2. Estimated financial impact of the proposal on appropriations

3.2.1. Summary of estimated impact on operational appropriations

–  The proposal/initiative does not require the use of operational appropriations

–  The proposal/initiative requires the use of operational appropriations, as explained below

Amounts are indicative and do not prejudge the outcome of the ongoing negotiations on the next MFF.

3.2.1.1. Appropriations from voted budget

EUR million (to three decimal places)

Heading of multiannual financial

framework Number 2

DG: <SANTE.> Year Year Year Year Year Year Year TOTAL

MFF

2028-2034

POST 2024 2028 2029 2030 2031 2032 2033 2034

Operational appropriations

TBA Commitments (1a) 0,297 0,303 0,309 0,315 0,322 0,328 0,335 2,210 0,335

Payments (2a) 0,059 0,209 0,303 0,309 0,315 0,321 0,694 2,210 0,694

Appropriations of an administrative nature financed from the envelope of specific programmes

Support expenditure (3) 1,010 1,010 1,010 1,010 1,010 1,010 1,010 7,070 1,010

TOTAL appropriations Commitments =1a+1b+3 1,307 1,313 1,319 1,325 1,332 1,338 1,345 9,280 1,345

for DG <SANTE> Payments =2a+2b+3 1,069 1,219 1,313 1,319 1,325 1,331 1,704 9,280 1,704

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged.

EN 15 EN

EUR million (to three decimal places)

[Agency]:

<EMA>

Year Year Year Year Year Year Year TOTAL

2028 - 2034

POST

2028 2029 2030 2031 2032 2033 2034 2034(annual

expenditure)

TBA /

Union

contribution

to the

European

Medicines

Agency

3,209 4,689 4,782 4,878 4,976 5,075 5,177 32,785 5,280

Without prejudice to the negotiations on the next MFF, the appropriations allocated to the agency from 2028 onwards will be compensated via

redeployments from applicable programmes of the same heading as the agency under the 2028-2034 MFF. If a compensatory reduction is

needed, the resources allocated to the agencies and their funding streams may need to be revised.

Year Year Year Year Year Year Year TOTAL

MFF

2028-2034

POST 2034

2028 2029 2030 2031 2032 2033 2034 Annual

expenditure

TOTAL

operational

appropriations

(including

contribution to decentralised

agency)

Commitments (4) 3,506 4,992 5,092 5,193 5,297 5,403 5,511 34,995 5,615

Payments (5) 3,268 4,898 5,085 5,187 5,290 5,396 5,870 34,995 5,974

EN 16 EN

TOTAL appropriations of an

administrative nature financed

from the envelope for specific

programmes

(6) 1,010 1,010 1,010 1,010 1,010 1,010 1,010 7,070 1,010

TOTAL

appropriations

under

HEADING

<SANTE>

Commitments =4+6 4,516 6,002 6,102 6,203 6,307 6,413 6,521 42,065 6,6256

of the

multiannual

financial

framework

Payments =5+6 4,278 5,908 6,095 6,197 6,300 6,406 6,880 42,065 6,984

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged.

====================================================================================================

==================================================================================================

EN 17 EN

Heading of multiannual financial framework 4 ‘Administrative expenditure’58

VOTED APPROPRIATIONS

Year Year Year Year Year Year Year TOTAL

2028 -

2034

POST

2028 2029 2030 2031 2032 2033 2034 2034(annual

expenditure)

HEADING 4

Human resources 2,820 2,820 2,820 2,820 2,820 2,820 2,820 19,740 2,820

Other administrative expenditure 0,108 0,110 0,113 0,115 0,117 0,120 0,122 0,805 0,122

Subtotal HEADING 4 2,928 2,930 2,933 2,935 2,937 2,940 2,942 20,545 2,942

Outside HEADING 4

Human resources 1,010 1,010 1,010 1,010 1,010 1,010 1,010 7,070 1,010

Other expenditure of an administrative nature 0,000 0,000 0,000 0,000 0,000 0,000 0,000 0,000 0,000

Subtotal outside HEADING 4 1,010 1,010 1,010 1,010 1,010 1,010 1,010 7,070 1,010

TOTAL 3,938 3,940 3,943 3,945 3,947 3,950 3,952 27,615 3,952

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged.

58 The necessary appropriations should be determined using the annual average cost figures available on the appropriate BUDGpedia webpage.

EN 18 EN

EUR million (to three decimal places)

TOTAL HEADING 1 to 4

Year Year Year Year Year Year Year TOTAL MFF

2028-2034 2028 2029 2030 2031 2032 2033 2034

TOTAL

appropriations

under

HEADINGS 1

to 4

Commitments 7,444 8,932 9,034 9,138 9,244 9,353 9,463 62,610

of the

multiannual

financial

framework

Payments 7,207 8,838 9,028 9,132 9,238 9,346 9,822 62,610

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged.

EN 19 EN

3.2.2. Estimated output funded from operational appropriations

Commitment appropriations in EUR million (to three decimal places)

Indicate

objectives and

outputs Year Year Year Year Year Year Year

TOTAL

2028-2034

POST

 2028 2029 2030 2031 2032 2033 2034 2034

OUTPUTS

Type

Average

cost No Cost No Cost No Cost No Cost No Cost No Cost No Cost No Cost No Cost

SPECIFIC OBJECTIVE No 1, No 2 and No3

- Eudamed-

maintenance and

adaptation of the

system to the new

requirements 0,297 0,303 0,309 0,315 0,322 0,328 0,335 2,210 0,335

Subtotal for specific objective No 1 0,297 0,303 0,309 0,315 0,322 0,328 0,335 2,210 0,335

TOTALS 0,297 0,303 0,309 0,315 0,322 0,328 0,335 2,210 0,335

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged.

EN 20 EN

3.2.3. Summary of estimated impact on administrative appropriations

–  The proposal/initiative does not require the use of appropriations of an

administrative nature

–  The proposal/initiative requires the use of appropriations of an administrative

nature, as explained below

3.2.3.1. Appropriations from voted budget

VOTED

APPROPRIATIONS

Year Year Year Year Year Year Year TOTA

L

2028 -

2034

POST

2028 2029 2030 2031 2032 2033 2034

2034

Annual

expenditure

)

HEADING 4

Human resources 2,820 2,820 2,820 2,820 2,820 2,820 2,820 19,740 2,820

Other administrative expenditure 0,108 0,110 0,113 0,115 0,117 0,120 0,122 0,805 0,122

Subtotal HEADING 4 2,928 2,930 2,933 2,935 2,937 2,940 2,942 20,545 2,942

Outside HEADING 4

Human resources 1,010 1,010 1,010 1,010 1,010 1,010 1,010 7,070 1,010

Other expenditure of an

administrative nature 0,000 0,000 0,000 0,000 0,000 0,000 0,000 0,000 0,000

Subtotal outside HEADING 4 1,010 1,010 1,010 1,010 1,010 1,010 1,010 7,070 1,010

TOTAL 3,938 3,940 3,943 3,945 3,947 3,950 3,952 27,615 3,952

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034

MFF negotiations which cannot be prejudged.

The appropriations required for human resources and other expenditure of an administrative nature

cannot be met by redeployment within DG SANTE and will be met by redeployement within the

Commission under the annual allocation procedure and in the light of budgetary constraints.

3.2.4. Estimated requirements of human resources

–  The proposal/initiative does not require the use of human resources

–  The proposal/initiative requires the use of human resources, as explained

below

EN 21 EN

3.2.4.1. Financed from voted budget

Estimate to be expressed in full-time equivalent units (FTEs)59

VOTED APPROPRIATIONS

Year Year Year Year Year Year Year POST

2028 2029 2030 2031 2032 2033 2034 2034

 Establishment plan posts (officials and temporary staff)

20 01 02 01 (Headquarters and Commission’s

Representation Offices) 15 15 15 15 15 15 15 15

20 01 02 03 (EU Delegations) 0 0 0 0 0 0 0 0

01 01 01 01 (Indirect research) 0 0 0 0 0 0 0 0

01 01 01 11 (Direct research) 0 0 0 0 0 0 0 0

Other budget lines (specify) 0 0 0 0 0 0 0 0

• External staff (in Full Time Equivalent unit: FTE)

20 02 01 (AC, END from the ‘global envelope’) 0 0 0 0 0 0 0 0

20 02 03 (AC, AL, END and JPD in the EU Delegations) 0 0 0 0 0 0 0 0

Admin. Support

line

[XX.01.YY.YY]

[2]

- at Headquarters 0 0 0 0 0 0 0 0

- in EU Delegations 0 0 0 0 0 0 0 0

01 01 01 02 (AC, END - Indirect research) 0 0 0 0 0 0 0 0

01 01 01 12 (AC, END - Direct research) 0 0 0 0 0 0 0 0

Other budget lines (specify) - Heading 4 0 0 0 0 0 0 0 0

Other budget lines (Support Credits budget line of the Health programme) - Outside Heading 4

10 10 10 10 10 10 10 10

TOTAL 25 25 25 25 25 25 25 25

59 Please specify below the table how many FTEs within the number indicated are already assigned to the

management of the action and/or can be redeployed within your DG and what are your net needs.

EN 22 EN

Considering the overall strained situation in Heading 4, in terms of both staffing and the level of appropriations,

the human resources required will be met by staff from the DG who are already assigned to the management of

the action and/or have been redeployed within the DG or other Commission services.

The internal staff (15 FTEs) required to implement the proposal (in FTEs) will be covered with

additional staff to be financed under heading 4. The additional external staff(10 FTEs) will be

financed from the Support expenditure of the programme budget line.

To be covered by

current staff

available in the

Commission

services

Exceptional additional staff*

To be financed

under Heading 4

or Research

To be financed

from BA line

To be financed

from fees

Establishment

plan posts

15 N/A

External staff

(CA, SNEs, INT)

10

* The tasks included in the proposal at stake cannot be covered fully by existing HR

resources and internal redeployments within DG SANTE because the existing resources are

already allocated to tasks stemming from the current legislative framework and cannot

therefore be redeployed. Moreover, new different profiles will be needed for the

implementation of the proposal.

Description of tasks to be carried out by:

Officials and temporary staff 1. Additional 13 FTEs (5 AD + 2 AST + 6 CA FG IV) will be needed to

support joint assessments of notified bodies, the new joint monitoring

activities and enhanced coordination efforts.

2. Additional 12 FTEs (8 AD and 4 CA FG IV) are needed to secure

implementation, in view of the stronger EU oversight of Notified Bodies and

other relevant regulatory activities (i.e. strengthening coordination, delegated

and implementing acts, activities of the NBO Working Group to resolve

divergent opinions and disputes, participation in international/reliance

programmes, the resolution of qualification and classification disputes).

External staff Please see above

3.2.5. Overview of estimated impact on digital technology-related investments

Compulsory: the best estimate of the digital technology-related investments entailed

by the proposal/initiative should be included in the table below.

Exceptionally, when required for the implementation of the proposal/initiative, the

appropriations under Heading 4 should be presented in the designated line.

The appropriations under Headings 1-3 should be reflected as “Policy IT expenditure

on operational programmes”. This expenditure refers to the operational budget to be

used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation

of the initiative and their associated investments (e.g. licences, studies, data storage

EN 23 EN

etc). The information provided in this table should be consistent with details

presented under Section 4 “Digital dimensions”.

TOTAL Digital

and IT

appropriations

Year Year Year Year Year Year Year TOTAL

MFF

2028 -

2034 2028 2029 2030 2031 2032 2033 2034

HEADING 4

IT expenditure (corporate)

0 0 0 0 0 0 0 0

Subtotal

HEADING 4 0 0 0 0 0 0 0 0

Outside HEADING 4

Policy IT expenditure on operational programmes

0,297 0,303 0,309 0,315 0,322 0,328 0,335 2,210

Subtotal outside

HEADING 4 0 0 0 0 0 0 0 0

TOTAL 0,297 0,303 0,309 0,315 0,322 0,328 0,335 2,210

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034

MFF negotiations which cannot be prejudged.

3.2.6. Compatibility with the current multiannual financial framework

The proposal/initiative:

–  can be fully financed through redeployment within the relevant heading of the

multiannual financial framework (MFF)

The initiative will be fully financed via redeployments from programmes under the

2028-2034 MFF.60

3.2.7. Third-party contributions

The proposal/initiative:

–  does not provide for co-financing by third parties

–  provides for the co-financing by third parties estimated below:

60

EN 24 EN

Appropriations in EUR million (to three decimal places)

Year Year Year Year Year Year Year

Total 2028 2029 2030 2031 2032 2033 2034

Specify the co-

financing body

TOTAL

appropriations

co-financed

3.2.8. Estimated human resources and the use of appropriations required in a

decentralised agency

Staff requirements (full-time equivalent units)

[Agency]: <EMA> Year Year Year

Year Year Year Year POST

2028 2029 2030 2031 2032 2033 2034 2034(annual

number)

Temporary agents (AD Grades) 5 5 5 5 5 5 5 5

Temporary agents (AST grades) 3 3 3 3 3 3 3 3

Temporary agents (AD+AST) subtotal 8 8 8 8 8 8 8 8

Contract staff 16 16 16 16 16 16 16 16

Seconded National Experts

Contract agents and SNE subtotal 16 16 16 16 16 16 16 16

TOTAL staff 24 24 24 24 24 24 24 24

Appropriations covered by the EU budget contribution in EUR million (to three decimal places)

[Agency]: Year Year Year Year Year Year Year TOTAL POST

EN 25 EN

<EMA>

2028 2029 2030 2031

2032 2033 2034 2028 -

2034

2034(an

nual

expendi

ture)

Title 1: Staff

expenditure 1,808 3,688 3,762 3,837 3,914 3,992 4,072 25,075 4,154

Title 2:

Infrastructur

e and

operating

expenditure

0,000

Title 3:

Operational

expenditure

1,401 1,000 1,020 1,041 1,061 1,083 1,104 7,710 1,126

TOTAL of

appropriati

ons covered

by the EU

Budget

3,209 4,698 4,782 4,878 4,976 5,075 5,177 32,785 5,280

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034

MFF negotiations which cannot be prejudged.

Appropriations covered by fees, if applicable, in EUR million (to three decimal places)

[Agency]: <EMA> Year Year Year Year Year Year Year TOTAL

2028 -

2034

POST

2028 2029 2030 2031 2032 2033 2034 2034(annual

expenditure)

Title 1: Staff

expenditure 0,000

Title 2: Infrastructure

and operating

expenditure

0,000

Title 3: Operational

expenditure

0,600 0,610 0,650 0,750 0,770 0,800 4,180 0,816

TOTAL of

appropriations

covered by fees

0,000 0,600 0,610 0,650 0,750 0,770 0,800 4,180 0,816

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034

MFF negotiations which cannot be prejudged.

Overview/summary of human resources and appropriations (in EUR million) required by the

proposal/initiative in a decentralised agency

[Agency]: Year Year Year Year Year Year Year TOTAL POST

EN 26 EN

<EMA> 2028 2029 2030 2031 2032 2033 2034

2028 -

2034

2034(annual

expenditure)

Temporary

agents

(AD+AST)

8 8 8 8 8 8 8 8

Contract agents 16 16 16 16 16 16 16 16