Kandidaatide esitamine

Annex I - estimated EU wide capacities for EURLs.pdf

Annex I

Scopes of designation and estimated minimum EU-wide capacity for tasks in points (a)

and (b) of Article 100(2) of Regulation (EU) 2017/746

In 2022, the European Commission launched a first call for the designation of EU reference

laboratories in 8 categories of class D devices (see main text of the call for the list of

categories). Five laboratories were designed as EU reference laboratories covering four

device categories (categories: 1, 2, 3, 5). For the remaining 4 categories (categories 4, 6, 7, 8),

there were either no laboratories that satisfied the criteria or their combined capacity was

insufficient to cover the expected volume of requests for tasks referred to in Article 100(2)(a)

and (b) of Regulation (EU) 2017/746. Therefore, no EU reference laboratory was designated

for these categories of devices following the first call.

The current second call for applications will be run in two waves:

1) a first early application wave for the following currently not covered categories of

class D devices:

- detection or quantification of markers of arboviruses (category 4);

- detection or quantification of markers of parasite infection (category 7);

- detection of blood grouping markers (category 8);

2) a second wave open for all 8 categories of class D devices.

The tables below list the estimated minimum EU-wide capacities for each device category for

the two waves, for the EURL tasks referred to in Article 100(2) (a) and (b) of Regulation

(EU) 2017/746.

One or more of the categories 1-8 in these tables can constitute the scope of designation of

the EU reference laboratories. Each category includes several groups of devices listed as 1.1,

1.2, 1.3 etc. A laboratory must cover as a minimum all the groups in the category it is

designated for, and also any other devices falling in the category (with the exception of

category 8, where only the listed groups must be covered).

N.B.: It is possible for a device detecting/quantifying a given marker to fall into different risk

classes depending on its intended purpose. For example, a device detecting Treponema

pallidum can be class D if intended for screening blood donations or class C if intended to

diagnose syphilis in the individual. The below devices are in scope of the EURL only if they

fall in class D according to Annex VIII of Regulation (EU) 2017/746.

1. Categories and groups for the first application wave

Category

n°/ group

n°

Category or group Estimated minimum

capacity in terms of annual

EU-wide number of

submissions to EURL(s)

according to Article

100(2)(a) of Regulation

(EU) 2017/746

(performance verification)

Estimated minimum

capacity in terms of annual

EU-wide number of

submissions to EURL(s)

according to Article

100(2)(b) of Regulation (EU)

2017/746 (batch testing)

4 Detection or quantification

of markers of arbovirus

infection

14 200

4.1 West Nile virus 3 50

4.2 Dengue virus 5 50

4.3 Chikungunya virus 3 50

4.4 Zika virus 3 50

7 Detection or quantification

of markers of parasite

infection

15 190

7.1 Plasmodium spp. 5 30

7.2 Trypanosoma cruzi 5 60

7.3 Toxoplasma gondii 5 100

8 Detection of blood

grouping markers

78 3150

8.1 ABO system 30 1500

8.2 Rhesus system 30 1000

8.3 Kell system 6 450

8.4 Kidd system 6 100

8.5 Duffy system 6 100

2. Categories and groups for the second application wave

Category

n°/ group

n°

Category or group Estimated minimum

capacity in terms of annual

EU-wide number of

submissions to EURL(s)

according to Article

100(2)(a) of Regulation

(EU) 2017/746

(performance verification)

Estimated minimum

capacity in terms of annual

EU-wide number of

submissions to EURL(s)

according to Article

100(2)(b) of Regulation (EU)

2017/746 (batch testing)

1 Detection or quantification

of markers of hepatitis or

retrovirus infection

Detection: 84

Quantification: 29

Detection: 2705

Quantification: 1005

1.1 Human immunodeficiency

virus 1/2

Detection: 30

Quantification: 10

Detection: 800

Quantification: 350

1.2 Hepatitis B virus Detection: 20

Quantification: 8

Detection: 1000

Quantification: 350

1.3 Hepatitis C virus Detection: 20

Quantification: 10

Detection: 500

Quantification: 300

1.4 Hepatitis D virus Detection: 5

Quantification: 1

Detection: 100

Quantification: 5

1.5 Hepatitis E virus Detection: 1 Detection: 5

1.6 Human T-cell lymphotropic

virus I/II

Detection: 8 Detection: 300

2 Detection or quantification

of markers of herpesvirus

infection

16 500

2.1 Cytomegalovirus 8 250

2.2 Epstein-Barr virus 8 250

3 Detection or quantification

of markers of infection with

bacterial agents

8 200

3.1 Treponema pallidum 8 200

4 Detection or quantification

of markers of arbovirus

infection

14 200

4.1 West Nile virus 3 50

4.2 Dengue virus 5 50

4.3 Chikungunya virus 3 50

4.4 Zika virus 3 50

5

Detection or quantification

of markers of respiratory

virus infection

45 220

5.1 Highly virulent influenza

virus

20 100

5.2 Highly virulent coronavirus

(SARS, MERS)

25 120

6 Detection or quantification

of markers of infection with

haemorrhagic fever viruses

or other biosafety level 4

viruses

15 65

6.1 Ebola virus 3 15

6.2 Marburg virus 3 15

6.3 Lassa virus 3 15

6.4 Smallpox virus 3 10

6.5 Crimean-Congo

haemorrhagic fever virus

3 10

7 Detection or quantification

of markers of parasite

infection

15 190

7.1 Plasmodium spp. 5 30

7.2 Trypanosoma cruzi 5 60

7.3 Toxoplasma gondii 5 100

8 Detection of blood

grouping markers

78 3150

8.1 ABO system 30 1500

8.2 Rhesus system 30 1000

8.3 Kell system 6 450

8.4 Kidd system 6 100

8.5 Duffy system 6 100

Annex II - instructions for CIRCABC submissions.pdf

Annex II

Instructions for submitting the application

1. For the first application wave, Member States are requested to submit the applications

not later than 12:00 (midday) Central European Time on 6 June 2025. No extension of

the deadline is possible. Applications submitted after the deadline will be

considered in the second application wave.

It is highly recommended that candidate laboratories send their applications to their

Member States no later than 12:00 (midday) Central European Time on 15 April 2025.

2. For the second application wave, Member States are requested to submit the

applications not later than 12:00 (midday) Central European Time on 15 April 2026. No

extension of the deadline is possible. Applications submitted after the deadline will

not be considered.

It is highly recommended that candidate laboratories send their applications to their

Member States no later than 12:00 (midday) Central European Time on 15 January 2026.

3. Member States must carefully follow the instructions in this call.

4. Only applications submitted by the Member States or the European Commission’s Joint

Research Centre (JRC) and for which they have verified the compliance with selection

criteria will be considered.

5. Member States or the JRC must complete and submit the following documents:

• Application form (Annex III or Annex IV)

• Visa section Declaration on honour regarding exclusion criteria (Annex V)

• Visa section of Declaration of independence of the candidate laboratory (Annex

VII)

• Template for verification of compliance with selection criteria (Annex X)

• Confirmation of the Member States regarding the performance of tasks in the

public interest and in an independent manner (Annex XI)

In addition, Member States are responsible for submitting the supporting documents

referred to in sections 3 and 4 of this call, as prepared by the candidate laboratories.

Supporting documents for the selection criteria in section 3 are requested at the initial

application stage, by the above deadline. Supporting documents for the preference

criteria in section 4 might be requested by the European Commission at a later stage and

only in case of need.

6. The application must be submitted electronically via Secure CIRCABC. Each Member

State will have its own dedicated folder in the relevant Secure CIRCABC Interest Group.

Individual Member State representatives will need to have a personal EU Login account1

that will be granted for accessing this folder. To nominate up to 3 Member States

representatives for access to the CIRCABC Interest group, please send an email to: JRC-

1 EU Login accounts can be created at https://webgate.ec.europa.eu/cas/about.html

[email protected] with their name/surname and email addresses.

Accessing Secure CIRCABC requires EU Login with 2-factors authentication methods

(e.g. Mobile Phone + SMS)2. Then proceed with the following steps:

• Access the Secure CIRCABC Interest Group at https://classified.circabc.europa.eu/

• On the top Menu click Library, then click the folder of the Member State

• Click the Button ADD and select FILES

• Select the file(s) to be uploaded by clicking ADD FILES or simply dragging and

dropping the file(s) in the dashed area

• Click UPLOAD and then FINISH

Applications submitted by other means will not be considered. For technical assistance

during the submission, please send an email to: [email protected]

2 To add a mobile phone number to a EU Login account, login to https://webgate.ec.europa.eu/cas/about.html

Click to gear icon beside the user name (at the top right of the page). Click My Account page and then Manage

my mobile phone numbers

Annex III - knowledge and experience requirements for staff.pdf

Annex III

Overview tables for knowledge and experience requirements of staff (point 2.1 of the

selection criteria)

This table can be prepared in Word or Excel format. Supporting documents such as CVs,

university diplomas, certificates must be included with the application and assigned a

reference number in the overview table.

Director

Name: Martin Dupont

Position: Director

Requirement Means of proof

University degree : Certificate ref. no.12345

2 years of

professional

experience:

See CV ref. no.23456

…1

Scientific staff

Name: Clara Wittstock Karl Lehmann …

Position: Scientific officer Scientific officer …

Requirement Means of proof

PhD in virology: Certificate ref. no.34567 …

2 years of

professional

experience:

See CV ref. no.45678 …

…

Technical staff

Name: Mario Rossi Laszlo Molnar …

Position: Technician Technician …

Requirement Means of proof

University degree: Certificate ref. no.56789

2 years of

professional

experience:

See CV ref. no.67890 …

…

1 Add requirements from list of knowledge and experience requirements (selection criterion 1.1)

Annex IV - estimated capacity of candidates.docx

Annex IV
Template for estimated minimum capacity of the candidate laboratory for tasks referred to in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746 (points 3.1 and 3.2 of the selection criteria)

Please indicate the estimated minimum capacity of the candidate laboratory for tasks referred to in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746 for one or more categories of devices which will constitute the proposed scope of designation.

For applications submitted for a single laboratory: Please note that the candidate must cover all the groups within the category. Therefore all the individual group capacities within the selected category or categories must be filled in.

For applications submitted for a consortium: Individual consortium members may cover some or all of the groups within the category. The consortium as a whole must cover the entire selected category or categories.

Note: Table 1 refers to the first application wave, while Table 2 refers to the second application wave. Please fill in one of tables as applicable.

Table 1: Categories and groups applicable to the first application wave and estimated minimum capacity
No
Category or group
Estimated minimum capacity of the candidate laboratory for tasks referred to in point (a) of Article 100(2) of Regulation (EU) 2017/746 (performance verification)
Estimated minimum capacity of the candidate laboratory for tasks referred to in point (b) of Article 100(2) of Regulation (EU) 2017/746 (batch testing)
4
Detection or quantification of markers of arbovirus infection

4.1
West Nile virus

4.2
Dengue virus

4.3
Chikungunya virus

4.4
Zika virus

7
Detection or quantification of markers of parasite infection

7.1
Plasmodium spp.

7.2
Trypanosoma cruzi

7.3
Toxoplasma gondii

8
Detection of blood grouping markers

8.1
ABO system

8.2
Rhesus system

8.3
Kell system

8.4
Kidd system

8.5
Duffy system

Notes or comments concerning the testing capacity of the candidate laboratory (e.g. indicate if the testing capacity can potentially be increased in the future, or other considerations on capacity estimates).

Table 2: Categories and groups applicable to the second application wave and estimated minimum capacity
No
Category or group
Estimated minimum capacity of the candidate laboratory for tasks referred to in point (a) of Article 100(2) of Regulation (EU) 2017/746 (performance verification)
Estimated minimum capacity of the candidate laboratory for tasks referred to in point (b) of Article 100(2) of Regulation (EU) 2017/746 (batch testing)
1
Detection or quantification of markers of hepatitis or retrovirus infection

1.1
Human immunodeficiency virus 1/2
Detection:
Quantification:
Detection:
Quantification:
1.2
Hepatitis B virus
Detection:
Quantification:
Detection:
Quantification:
1.3
Hepatitis C virus
Detection:
Quantification:
Detection:
Quantification:
1.4
Hepatitis D virus
Detection:
Quantification:
Detection:
Quantification:
1.5
Hepatitis E virus
Detection:
Detection:
1.6
Human T-cell lymphotropic virus I/II
Detection:
Detection:
2
Detection or quantification of markers of herpesvirus infection

2.1
Cytomegalovirus

2.2
Epstein-Barr virus

3
Detection or quantification of markers of infection with bacterial agents

3.1
Treponema pallidum

4
Detection or quantification of markers of arbovirus infection

4.1
West Nile virus

4.2
Dengue virus

4.3
Chikungunya virus

4.4
Zika virus

5

Detection or quantification of markers of respiratory virus infection

5.1
Highly virulent influenza virus

5.2
Highly virulent coronavirus (SARS, MERS)

6
Detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses

6.1
Ebola virus

6.2
Marburg virus

6.3
Lassa virus

6.4
Smallpox virus

6.5
Crimean-Congo haemorrhagic fever virus

7
Detection or quantification of markers of parasite infection

7.1
Plasmodium spp.

7.2
Trypanosoma cruzi

7.3
Toxoplasma gondii

8
Detection of blood grouping markers

8.1
ABO system

8.2
Rhesus system

8.3
Kell system

8.4
Kidd system

8.5
Duffy system

Notes or comments concerning the testing capacity of the candidate laboratory (e.g. indicate if the testing capacity can potentially be increased in the future, or other considerations on capacity estimates).

Annex IX - application form consortia.docx

Annex IX
Application form for a consortium
Nominating Member State 1: ………………………………………………..
Competent authority 1: ………………………………………………………….
Contact person regarding this application in Member State 1:
Name: ………………………………………………………
Email:……………………………………………………
Phone number:…………………………………………..
If applicable1:
Nominating Member State 2: ………………………………………………..
Competent authority 2: ………………………………………………………….
Contact person regarding this application in Member State 2:
Name: ………………………………………………………
Email:……………………………………………………
Phone number:…………………………………………..
Consortium member 1
Full name of consortium member 1 in English: ………………………………………..
Full name of consortium member 1 in national language:………………………………………………………………………….
Address of consortium member 1: ……………………………………………………….
Consortium member 22
Full name of consortium member 2 in English: ………………………………………..
Full name of consortium member 2 in national language:………………………………………………………………………….
Address of consortium member 2: ……………………………………………………….

Please fill in either Table 1 or Table 2 depending on the application wave.
Table 1: Proposed scope of designation of the consortium as a whole, if applying as part of the first application wave:
No
Category
Please tick
4
Detection or quantification of markers of arbovirus infection

7
Detection or quantification of markers of parasite infection

8
Detection of blood grouping markers

Table 2: Proposed scope of designation of the consortium as a whole, if applying as part of the second application wave:
No
Category
Please tick
1
Detection or quantification of markers of hepatitis or retrovirus infection

2
Detection or quantification of markers of herpesvirus infection

3
Detection or quantification of markers of infection with bacterial agents

4
Detection or quantification of markers of arbovirus infection

5
Detection or quantification of markers of respiratory virus infection

6
Detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses

7
Detection or quantification of markers of parasite infection

8
Detection of blood grouping markers

Annex V - declaration on exclusion criteria.docx

Annex V
Declaration on honour regarding exclusion criteria (point 9.7 of the selection criteria)

Full official name of the candidate laboratory: ………………………….
Full address of the candidate laboratory: ……………………….

I, the undersigned, [insert name]……………………..……, [insert function of the undersigned in the laboratory]…………………………….., and thus legally authorised representative of the abovementioned laboratory vis-à-vis third parties and acting on behalf of that laboratory,
in the context of the call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices according to Article 100 of Regulation (EU) 2017/746,
declare that the candidate laboratory mentioned above is not in any of the following situations for exclusion set out in Article 136 of Regulation (EU) 2018/10461:
(a) the person or entity is bankrupt, subject to insolvency or winding-up procedures, its assets are being administered by a liquidator or by a court, it is in an arrangement with creditors, its business activities are suspended, or it is in any analogous situation arising from a similar procedure provided for under Union or national law;
(b) it has been established by a final judgment or a final administrative decision that the person or entity is in breach of its obligations relating to the payment of taxes or social security contributions in accordance with the applicable law;
(c) it has been established by a final judgment or a final administrative decision that the person or entity is guilty of grave professional misconduct by having violated applicable laws or regulations or ethical standards of the profession to which the person or entity belongs, or by having engaged in any wrongful conduct which has an impact on its professional credibility where such conduct denotes wrongful intent or gross negligence, including, in particular, any of the following:
(i) fraudulently or negligently misrepresenting information required for the verification of the absence of grounds for exclusion or the fulfilment of eligibility or selection criteria or in the implementation of the legal commitment;
(ii) entering into agreement with other persons or entities with the aim of distorting competition;
(iii) violating intellectual property rights;
(iv) attempting to influence the decision-making of the authorising officer responsible during the award procedure;
(v) attempting to obtain confidential information that may confer upon it undue advantages in the award procedure;
(d) it has been established by a final judgment that the person or entity is guilty of any of the following:
(i) fraud, within the meaning of Article 3 of Directive (EU) 2017/1371 of the European Parliament and of the Council and Article 1 of the Convention on the protection of the European Communities’ financial interests, drawn up by the Council Act of 26 July 1995;
(ii) corruption, as defined in Article 4(2) of Directive (EU) 2017/1371 or active corruption within the meaning of Article 3 of the Convention on the fight against corruption involving officials of the European Communities or officials of Member States of the European Union, drawn up by the Council Act of 26 May 1997, or conduct referred to in Article 2(1) of Council Framework Decision 2003/568/JHA, or corruption as defined in other applicable laws;
(iii) conduct related to a criminal organisation as referred to in Article 2 of Council Framework Decision 2008/841/JHA;
(iv) money laundering or terrorist financing within the meaning of Article 1(3), (4) and (5) of Directive (EU) 2015/849 of the European Parliament and of the Council;
(v) terrorist offences or offences linked to terrorist activities, as defined in Articles 1 and 3 of Council Framework Decision 2002/475/JHA, respectively, or inciting, aiding, abetting or attempting to commit such offences, as referred to in Article 4 of that Decision;
(vi) child labour or other offences concerning trafficking in human beings as referred to in Article 2 of Directive 2011/36/EU of the European Parliament and of the Council;
(e) the person or entity has shown significant deficiencies in complying with main obligations in the implementation of a legal commitment financed by the budget which has:
(i) led to the early termination of a legal commitment;
(ii) led to the application of liquidated damages or other contractual penalties; or
(iii) been discovered by an authorising officer, OLAF or the Court of Auditors following checks, audits or investigations;
(f) it has been established by a final judgment or final administrative decision that the person or entity has committed an irregularity within the meaning of Article 1(2) of Council Regulation (EC, Euratom) No 2988/95;
(g) it has been established by a final judgment or final administrative decision that the person or entity has created an entity in a different jurisdiction with the intent to circumvent fiscal, social or any other legal obligations in the jurisdiction of its registered office, central administration or principal place of business;
(h) it has been established by a final judgment or final administrative decision that an entity has been created with the intent referred to in point (g).

Full name: Date:
Signature:
__________________________________________________________________________
Visa of the Member State where the laboratory is located:
Member State:
Name of competent authority:
Name of contact person:
Signature:
Date:

Annex VI A - criteria for economic and financial viability.pdf

Criteria used for evaluation of economic and financial capacity

On the basis of the data from the 'Simplified Presentation' form in Annex VI B, a number of

values and ratios will be calculated in order to evaluate the economic and financial capacity of

the candidate.

The following values will be calculated:

Value Formula/source Unfavourable if:

own funds from the balance sheet negative

own funds - paid-up capital negative

working capital permanent capital - fixed assets negative

gross operating surplus from the P&L accounts negative

net result from the P&L accounts negative

self-financing capacity

(SFC)

net result after tax + amortization –

capitalized production negative

Following ratios are calculated:

Ratio Formula

Unfavourable

if Average if

Favourable

if

general

liquidity

current assets/short-

term debts below 1

between 1

and 1.25 Above 1.25

financial

independence

own funds/total

liabilities below 0.20

between 0.20

and 0.40 above 0.40

indebtedness

own funds/medium &

long-term debts

(MLT) below 0.30

between 0.30

and 0.60 above 0.60

coverage of

deposits and

borrowed funds

by the SFC SFC / MLT debts below 0.25

between 0.25

and 0.50 above 0.50

profitability

gross operating

surplus / turnover below 0.10

between 0.10

and 0.20 above 0.20

Each type of evaluation has a corresponding scoring (number of points) as follows:

Scoring

Unfavourable value/ratio 0 points

Favourable value 1 point

Average ratio 1 point

Favourable ratio 2 points

If, for some exceptional reason which the Commission considers justified, the candidate is

unable to provide the references requested by the Commission, or if he feels that the financial

viability check does not provide an accurate picture of his organisation's financial status, he

may prove his economic and financial capacity by any other means which the Commission

considers appropriate.

Annex VI B - simplified viability checks.xlsx

Annex VII - candidate declaration on independence.docx

Annex VII
Declaration of independence of the candidate laboratory (point 13.1 of the selection criteria)

Full name of the candidate laboratory: ………………………….
Full address of the candidate laboratory: ……………………….

I, the undersigned, [insert name]……………………..……, [insert function of the undersigned in the laboratory]…………………………….., and thus legally authorised representative of the abovementioned laboratory vis-à-vis third parties and acting on behalf of that laboratory,
in the context of the call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices according to Article 100 of Regulation (EU) 2017/746,
declare that the candidate laboratory mentioned above, if designated, will not:
1. be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices within the proposed scope of designation, nor the authorised representative of any of those parties;
2. be involved in the design, manufacture or construction, marketing, installation, use or maintenance of the devices within the proposed scope of designation;
3. be a notified body for devices within the proposed scope of designation;
4. perform any tasks related to conformity assessment under Regulation (EU) 2017/746 on request of a notified body, other than the tasks referred to in Article 100(2) of Regulation (EU) 2017/746, within the scope of designation of the laboratory.
5. enter into collaboration with a device manufacturer or a notified body concerning a joint commercial exploitation, if such collaboration falls within the scope of its designation.

Full name: Date:
Signature:
__________________________________________________________________________
Visa of the Member State where the laboratory is located:
Member State:
Name of competent authority:
Name of contact person:
Signature:
Date:

Annex VIII - application form single laboratories.docx

Annex VIII
Application form for single laboratories
Nominating Member State: ………………………………………………..
Competent authority: ………………………………………………………….
Contact person regarding this application in the Member State:
Name: ………………………………………………………
Email:……………………………………………………
Phone number:…………………………………………..
Full name of candidate laboratory in English: ………………………………………..
Full name of candidate laboratory in national language:……………………………………….
Address of candidate laboratory: ……………………………………………………….

Please fill in either Table 1 or Table 2 depending on the application wave.
Table 1: Proposed scope of designation for the laboratory applying as part of the first application wave
No
Category
Please tick
4
Detection or quantification of markers of arbovirus infection

7
Detection or quantification of markers of parasite infection

8
Detection of blood grouping markers

Table 2: Proposed scope of designation for the laboratory applying as part of the second application wave
No
Category
Please tick
1
Detection or quantification of markers of hepatitis or retrovirus infection

2
Detection or quantification of markers of herpesvirus infection

3
Detection or quantification of markers of infection with bacterial agents

4
Detection or quantification of markers of arbovirus infection

5
Detection or quantification of markers of respiratory virus infection

6
Detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses

7
Detection or quantification of markers of parasite infection

8
Detection of blood grouping markers

Annex X - verification template for MS.docx

Annex X
Template for verification of compliance with the selection criteria by the Member State

Nominating Member State: ………………………………………………..
Competent authority: ………………………………………………………….
 Single laboratory application
 Consortium application – Please fill a separate verification template for each member of the consortium
Full name of candidate laboratory in English: ………………………………………..
Full name of candidate laboratory in national language:……………………………………
The candidate laboratory is accredited in accordance with EN ISO/IEC 17025:
 No – Please fill Table 1 starting on page 2.
 Yes – Issuing entity, date and number of certificate: ………………………………………….
In accordance with the above accreditation and Article 8 of the Commission Implementing Regulation 2022/944, the nominating Member State may grant presumption of conformity to the candidate laboratory for certain requirements set out in the Regulation 2022/944.
Presumption of conformity is granted:
 Yes – Please fill Table 2 and 3 starting on page 7.
 No – Please fill Table 1 starting on page 2.
Table 1: Verification table for candidate laboratories without ISO 17025 accreditation in scope of the EURL application
Criterion No
Means of proof
Supporting documents provided.
Please tick if yes and specify the document name
Member State verification.
Are the documents compliant with the selection criteria?
Justification / Comments - if any
1.1
List of knowledge and experience requirements for the director, the scientific staff and the technical staff

document(s) name:

 yes  no

2.1
Overview tables for knowledge and experience of the staff and the supporting documents

document(s) name:

 yes  no

3.1
Estimate of minimum capacity regarding performance verification

document(s) name:

 yes  no

3.2
Estimate of minimum capacity regarding batch testing

document(s) name:

 yes  no

3.3
Justification regarding the number of staff

document(s) name:

 yes  no

4.1
Description of the continuous training and education programme for the staff

document(s) name:

 yes  no

5.1
Justification regarding equipment and reference materials

document(s) name:

 yes  no

5.2
Evidence of possession of equipment and reference materials

document(s) name:

 yes  no

5.3
Plan for procurement of specimens, control materials and reference materials

document(s) name:

 yes  no

6.1
List of international standards and best practices, including common specifications

document(s) name:

 yes  no

6.2
Evidence of integration international standards and best practices, including common specifications

document(s) name:

 yes  no

7.1
Identification of the person having overall responsibility

document(s) name:

 yes  no

8.1
Estimate regarding volume of administrative work

document(s) name:

 yes  no

8.2
Justification of the number of administrative staff

document(s) name:

 yes  no

9.1
Evidence of the laboratory’s status as a legal entity

document(s) name:

 yes  no

9.2
If the laboratory is part of a larger organisation, information related to that larger organisation
If applicable: 
document(s) name:

 yes  no

9.3
If the laboratory is, directly or indirectly, controlled by other entities, the identity of such entities and their controlling position
If applicable: 
document(s) name:

 yes  no

9.4
Description of the laboratory’s internal organisational structure

document(s) name:

 yes  no

9.5
Description of the operating procedures

document(s) name:

 yes  no

9.6
Evidence of sources of funding

document(s) name:

 yes  no

9.7
Declaration on honour regarding exclusion criteria
 Candidate declaration
 Member State visa
document(s) name:

 yes  no

9.8.1
Economic viability template

document(s) name:

 yes  no

9.8.2
Balance sheets, profit and loss accounts or annual reports for the last three financial years

document(s) name:

 yes  no

9.8.3
Audit reports from the last three financial years
Where available: 
document(s) name:

 yes  no

9.9
Proposed system for records of costs and fees

document(s) name:

 yes  no

10.1
Confidentiality policy including the following:

document(s) name:

 yes  no

10.1.1 the type of information that is considered confidential

document(s) name:

 yes  no

10.1.2 rules for the appropriate secure handling, storage and processing of confidential information and measures to prevent undue disclosure

document(s) name:

 yes  no

10.1.3 rules for sharing of confidential and non-confidential information with staff, and the public

document(s) name:

 yes  no

10.1.4 rules for granting access to confidential information to a competent authority of a Member State upon its request in the context of market surveillance or vigilance activities by the competent authority

document(s) name:

 yes  no

10.1.5 rules for sharing confidential information, on the initiative of the EU reference laboratory, with a competent authority of a Member State and with the European Commission where the EU reference laboratory has reason to believe that such sharing is in the interest of protection of public health

document(s) name:

 yes  no

10.2
List of measures to ensure that the staff complies with the confidentiality policy

document(s) name:

 yes  no

11.1
Confirmation by the Member States regarding the performance of tasks in the public interest and in an independent manner

document(s) name:

 yes  no

12.1
Policy for the management of conflict of interest

document(s) name:

 yes  no

13.1
Declaration of independence of the candidate laboratory
 Candidate declaration
 Member State visa
document(s) name:

 yes  no

14.1
List of requirements regarding the tasks covered by the contract
If applicable: 
document(s) name:

 yes  no

14.2
Declaration regarding the external laboratories
If applicable: 
document(s) name:

 yes  no

Table 2: Verification table 1 for candidate laboratories with ISO 17025 accreditation in the scope of the EURL application
Criterion No

Member State granted presumption of conformity for the following Articles of Regulation (EU) 2022/944 to the EN ISO/IEC 17025 accredited candidate laboratory
1.1
List of knowledge and experience requirements for the director, the scientific staff and the technical staff
Article 1(1)
2.1
Overview tables for knowledge and experience of the staff and the supporting documents
Article 1(2)
3.3
Justification regarding the number of staff
Article 1(3)
4.1
Description of the continuous training and education programme for the staff
Article 1(4)
5.2
Evidence of possession of equipment and reference materials
Article 2(1), point (b)
7.1
Identification of the person having overall responsibility
Article 4(1)
8.1
Estimate regarding volume of administrative work
Article 4(2)
8.2
Justification of the number of administrative staff
Article 4(2)
9.1
Evidence of the laboratory’s status as a legal entity
Article 4(3), point (a)
9.4
Description of the laboratory’s internal organisational structure
Article 4(3), point (d)
9.5
Description of the operating procedures
Article 4(3), point (e)
10.1
Confidentiality policy including the following:

10.1.1 the type of information that is considered confidential
Article 5(1), point (a)

10.1.2 rules for the appropriate secure handling, storage and processing of confidential information and measures to prevent undue disclosure
Article 5(1), point (b)

10.1.3 rules for sharing of confidential and non-confidential information with staff, and the public
Article 5(1), point (c)
10.2
List of measures to ensure that the staff complies with the confidentiality policy
Article 5(2)
12.1
Policy for the management of conflict of interest
Article 6(2)
14.2
Declaration regarding the external laboratories
Article 7(3), point (a), (b), (c)

Certificate of accreditation according to EN ISO/IEC 17025
 Certificate provided

Table 3 Verification table 2 for candidate laboratories with ISO 17025 accreditation in the scope of the EURL application
Criterion No
Means of proof
Supporting documents provided.
Please tick if yes and specify the document name
Member State verification.
Are the documents compliant with the selection criteria?
Justification / Comments - if any
3.1
Estimate of minimum capacity regarding performance verification

document(s) name:

 yes  no

3.2
Estimate of minimum capacity regarding batch testing

document(s) name:

 yes  no

5.1
Justification regarding equipment and reference materials

document(s) name:

 yes  no

5.3
Plan for procurement of specimens, control materials and reference materials

document(s) name:

 yes  no

6.1
List of international standards and best practices, including common specifications

document(s) name:

 yes  no

6.2
Evidence of integration international standards and best practices, including common specifications

document(s) name:

 yes  no

9.2
If the laboratory is part of a larger organisation, information related to that larger organisation
If applicable: 
document(s) name:

 yes  no

9.3
If the laboratory is, directly or indirectly, controlled by other entities, the identity of such entities and their controlling position
If applicable: 
document(s) name:

 yes  no

9.6
Evidence of sources of funding

document(s) name:

 yes  no

9.7
Declaration on honour regarding exclusion criteria
 Candidate declaration
 Member State visa
document(s) name:

 yes  no

9.8.1
Economic viability template

document(s) name:

 yes  no

9.8.2
Balance sheets, profit and loss accounts or annual reports for the last three financial years

document(s) name:

 yes  no

9.8.3
Audits reports from the last three financial years
Where available: 
document(s) name:

 yes  no

9.9
Proposed system for records of costs and fees

document(s) name:

 yes  no

10.1
Confidentiality policy including the following:

10.1.4 rules for granting access to confidential information to a competent authority of a Member State upon its request in the context of market surveillance or vigilance activities by the competent authority

document(s) name:

 yes  no

10.1.5 rules for sharing confidential information, on the initiative of the EU reference laboratory, with a competent authority of a Member State and with the European Commission where the EU reference laboratory has reason to believe that such sharing is in the interest of protection of public health

document(s) name:

 yes  no

11.1
Confirmation by the Member States regarding the performance of tasks in the public interest and in an independent manner

document(s) name:

 yes  no

13.1
Declaration of independence of the candidate laboratory
 Candidate declaration
 Member State visa
document(s) name:

 yes  no

14.1
List of requirements regarding the tasks covered by the contract
If applicable: 
document(s) name:

 yes  no

Annex XI - MS confirmation on public interest and independence.docx

Annex XI
Confirmation of the Member States regarding the performance of tasks in the public interest and in an independent manner (point 11.1 of the selection criteria)

Nominating Member State:…………………………..
Full name of the competent authority: ………………………….
Full address of the competent authority: ……………………….

I, the undersigned, [insert name]……………………..……, [insert function of the undersigned in the competent authority]…………………………….., and thus legally authorised representative of the abovementioned competent authority vis-à-vis third parties and acting on behalf of that competent authority,
in the context of the call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices according to Article 100 of Regulation (EU) 2017/746,
confirm that the candidate laboratory mentioned below, if designated, will perform its tasks as an EURL in the public interest and in an independent manner:

Full name of the candidate laboratory: ………………………….
Full address of the candidate laboratory: ……………………….

Full name: Date:
Signature:

Call for applications for EURLs in the area of IVDs .pdf

1

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

SECOND CALL FOR

APPLICATIONS FOR DESIGNATION OF EU REFERENCE LABORATORIES

IN THE FIELD OF IN VITRO DIAGNOSTIC MEDICAL DEVICES

TERMS OF REFERENCE

2

Contents

1 INTRODUCTION ........................................................................................................................................ 3

1.1 Purpose ................................................................................................................................................. 3

1.2 Legal framework ................................................................................................................................. 3

2 THE PROCEDURE FOR SUBMISSION OF APPLICATIONS AND SELECTION OF EU

REFERENCE LABORATORIES ....................................................................................................................... 6

2.1 General procedure ............................................................................................................................... 6

2.2 Modalities applicable in case of the expression of interest by a consortium .................................. 7

3 SELECTION CRITERIA ............................................................................................................................ 8

4 PREFERENCE CRITERIA .......................................................................................................................14

5 SELECTION................................................................................................................................................15

3

1 INTRODUCTION

1.1 Purpose

The purpose of this second call for applications is to invite Member States and the European

Commission’s Joint Research Centre (JRC) to submit applications for laboratories in the

respective Member State or at JRC in view of their possible designation as EU reference

laboratories in the area of in vitro diagnostic medical devices according to Article 100 of

Regulation (EU) 2017/7461.

In 2022, the European Commission launched a first call for the designation of EU reference

laboratories in 8 categories of class D devices:

1 - Detection or quantification of markers of hepatitis or retrovirus infection

2 - Detection or quantification of markers of herpesvirus infection

3 - Detection or quantification of markers of infection with bacterial agents

4 - Detection or quantification of markers of arbovirus infection

5 - Detection or quantification of markers of respiratory virus infection

6 - Detection or quantification of markers of infection with haemorrhagic fever viruses

or other biosafety level 4 viruses

7 - Detection or quantification of markers of parasite infection

8 - Detection of blood grouping markers

Following the evaluation process, the European Commission designated 5 EU reference

laboratories covering the categories 1, 2, 3 and 5.

For the remaining 4 categories (4, 6, 7 and 8) there were either no laboratories that satisfied the

criteria or their combined capacity was insufficient to cover the expected volume of requests

for tasks referred to in Article 100(2)(a) and (b) of Regulation (EU) 2017/746. Therefore, no

EU reference laboratory was designated for these categories of devices following the first call.

The current second call for applications will be run in two waves:

1) a first early application wave for the following currently not covered categories of class

D devices:

- detection or quantification of markers of arboviruses (category 4);

- detection or quantification of markers of parasite infection (category 7);

- detection of blood grouping markers (category 8);

2) a second wave open for all 8 abovementioned categories of class D devices.

Designated EU reference laboratories will address one or more of the specific categories of

class D in vitro diagnostic medical devices referred to in Annex I of this call. These categories

will constitute the scope of designation of the laboratories. Each category includes several

groups of devices also listed in Annex I. A laboratory must cover as a minimum all the listed

groups in the category it is designated for, and also any other devices falling in the category

(with the exception of category 8, where only the listed groups must be covered).

1 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

4

Candidate laboratories must provide evidence of compliance with the criteria set out in Article

100(4) of Regulation (EU) 2017/746, as further specified by Commission Implementing

Regulation (EU) 2022/944 on tasks and criteria of EU reference laboratories2, for the intended

scope of designation.

Please refer to Annex II for the timing of the waves for Member States and candidate

laboratories.

This call does not constitute an obligation on the European Commission to designate the EU

reference laboratories or award a financial contribution.

1.2 Legal framework

Tasks of EU reference laboratories

Pursuant to Article 100(2) of Regulation (EU) 2017/746, the tasks of EU reference laboratories,

within the scope of their designation, are the following:

(a) to verify the performance claimed by the manufacturer and the compliance of class D

devices with the applicable CS3, 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 the third subparagraph of Article 48(3);

(b) to carry out appropriate tests on samples of manufactured class D devices or batches of

class D devices, as provided for in the Section 4.12 of Annex IX and in Section 5.1 of

Annex XI;

(c) to provide scientific and technical assistance to the Commission, the MDCG4, the Member

States and notified bodies in relation to the implementation of this Regulation;

(d) to provide scientific advice regarding the state of the art in relation to specific devices, or

a category or group of devices;

(e) to set up and manage a network of national reference laboratories after consulting with the

national authorities and publish a list of the participating national reference laboratories

and their respective tasks;

(f) to contribute to the development of appropriate testing and analysis methods to be applied

for conformity assessment procedures and market surveillance;

(g) to collaborate with notified bodies in the development of best practices for the performance

of conformity assessment procedures;

2 Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of

Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for

European Union reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA

relevance) 3 CS: Common specifications. List of common specifications adopted under the Regulation (EU) 2017/746:

Commission Implementing Regulation (EU) 2022/1107 4 MDCG: Medical Device Coordination Group

5

(h) to provide recommendations on suitable reference materials and reference measurement

procedures of higher metrological order;

(i) to contribute to the development of CS and of international standards;

(j) to provide scientific opinions in response to consultations by notified bodies in accordance

with this Regulation and publish them by electronic means having considered national

provisions on confidentiality.

In addition, in accordance with Article 100(5) of Regulation (EU) 2017/746 the EU reference

laboratories must form a network in order to coordinate and harmonise their working methods

as regards testing and assessment. That coordination and harmonisation will involve:

(a) applying coordinated methods, procedures and processes;

(b) agreeing on the use of same reference materials and common test samples and

seroconversion panels;

(c) establishing common assessment and interpretation criteria;

(d) using common testing protocols and assessing the test results using standardised and

coordinated evaluation methods;

(e) using standardised and coordinated test reports;

(f) developing, applying and maintaining a peer review system;

(g) organizing regular quality assessment tests (including mutual checks on the quality and

comparability of test results);

(h) agreeing on joint guidelines, instructions, procedural instructions or standard operational

procedures;

(i) coordinating the introduction of testing methods for new technologies and according to

new or amended CS;

(j) reassessing the state of the art on the basis of comparative test results or by further studies,

as requested by a Member State or by the Commission.

Designation of EU reference laboratories

In accordance with Article 100(1) of Regulation (EU) 2017/746 the European Commission may

designate, by means of implementing acts, one or more EU reference laboratories for specific

devices, or a category or group of devices, or for specific hazards related to a category or group

of devices. The European Commission shall only designate the EU reference laboratories for

which a Member State or the European Commission’s Joint Research Centre has submitted an

application for designation.

6

The European Commission will designate the EU reference laboratories for a minimum period

of 5 years with extension subject to continued compliance with the criteria.

The European Commission may, by implementing act, suspend, withdraw or restrict the

designation in case of non-compliance (see Article 100(9) of Regulation (EU) 2017/746).

Financing of EU reference laboratories

According to Article 100(7) of Regulation (EU) 2017/746, where notified bodies or Member

States request scientific or technical assistance or a scientific opinion from an EU reference

laboratory, the EU reference laboratory may charge fees to cover the costs incurred by the

laboratory in carrying out the requested task according to predetermined and transparent terms

and conditions.

The Commission Implementing Regulation (EU) 2022/945 on the fees that may be levied by

EU reference laboratories5 identifies the categories of costs eligible to be covered by fees. Given

the wide variety of in vitro diagnostic devices on the EU market and the various tasks that can

be assigned to EU reference laboratories, the calculation of the exact fee for each task is at the

discretion of the EU reference laboratories.

The EU reference laboratories must determine the rules according to which they calculate the

fees for carrying out the requested tasks, including the rules for the estimation of incurred costs

based on average costs, and make them publicly available. The fee levying system and related

documentation will be subject to controls referred to in Article 100(9) of Regulation (EU)

2017/746.

As laid down in Article 100(6) of Regulation (EU) 2017/746, the EU reference laboratories

may be granted a Union financial contribution. The European Commission may set out detailed

arrangements and the amount of this contribution by means of implementing acts. The European

Commission will consider the establishment of the Union contribution following designation

of EU reference laboratories and evaluation of the needs for funding. It may in particular cover

the tasks of the EU reference laboratories not funded by fees and tasks of the network of EU

reference laboratories referred to in Article 100(5) of Regulation (EU) 2017/746.

2 THE PROCEDURE FOR SUBMISSION OF APPLICATIONS AND SELECTION OF EU REFERENCE

LABORATORIES

2.1 General procedure

1. The call is available in English only. English will be the working language for this call and

applications must be completed in English. Supporting documents should as much as

possible be provided in English, except where it would be inappropriate, such as national

accreditation certificates or other proof of competence in the form of certificates.

5 Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of

Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by

EU reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance)

7

2. The Member State and the candidate laboratory must decide on the proposed scope of

designation of the laboratory by selecting one or more categories of devices listed in Annex

I. The candidate laboratory must estimate its minimum capacity for tasks referred to in points

(a) and (b) of Article 100(2) of Regulation (EU) 2017/746 for each group of devices in the

selected category or categories. The Member State may submit the application if the

laboratory either partially or fully covers the estimated minimum EU-wide capacity for those

tasks as set out in Annex I. Please note that in case the laboratory only partially covers the

estimated minimum EU-wide capacity for a group of devices, its designation for the

corresponding category may also be conditional on availability of other candidates who fulfil

the selection criteria.

3. The selection criteria for EU reference laboratories in the field of in vitro diagnostic medical

devices are outlined in Section 3 of this call. The preference criteria are listed in Section 4.

4. As laid down in Article 100(1) of Regulation (EU) 2017/746, Member States are responsible

for submitting the completed application forms and supporting documentation for the

selection criteria for candidate laboratories they wish to propose to be designated as EU

reference laboratories to the European Commission. Supporting documentation for the

preference criteria must be submitted at a later stage only by those candidate laboratories for

which an assessment of preference criteria will be necessary, i.e. in case there are more

candidate laboratories for a category of devices with significantly higher collective capacity

than the estimated minimum EU-wide capacity. Please see Annex II for the detailed

instructions for submitting the application.

5. Before submitting the applications to the European Commission, the Member States must

verify that the candidate laboratory complies with the selection criteria in section 3. The

Member States must document the verification and its outcome in the template for

verification of compliance with the selection criteria, provided in Annex X.

6. A selection panel will be set up by the European Commission services. The panel will check

the verification of compliance with selection criteria performed by the Member States or the

European Commission’s Joint Research Centre for consistency and completeness. The panel

will also apply the preference criteria in case there are more candidate laboratories for a

category with considerably higher collective capacity than the estimated minimum EU-wide

capacity.

7. In case of need for minor clarification about the submitted application, supporting

documents or the verification template, the selection panel will contact the candidate

laboratory or the Member State, respectively.

8. In order to be designated, the candidates must satisfy all the selection criteria.

In addition, the European Commission will seek to ensure that for each group of devices

listed in Annex I, the collective capacity of the designated EU reference laboratories

corresponds to a reasonable extent to the estimated minimum EU-wide capacity for tasks

referred to in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746, as set out in

Annex I.

8

Where several candidates fulfil all the selection criteria, and whose collective capacity is

significantly higher than the estimated minimum EU-wide capacity for tasks referred to in

points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746, as set out in Annex I, then

the preference criteria will be used to select the laboratories with the highest scores whose

collective capacity corresponds to a reasonable extent to the estimated minimum EU-wide

capacity.

In cases where the preference criteria need to be applied, the European Commission will

contact the relevant Member States with a request for candidate laboratories to submit them

within a specified deadline.

9. The Member States will be informed about the outcome of the selection.

10. Thereafter, as laid down in Article 100(1) of Regulation (EU) 2017/746, the European

Commission will designate the selected EU reference laboratories by means of an

implementing act. The act will identify the laboratories and the scope of the designation, i.e.

the categories of devices each of them will cover.

11. During the evaluation period, only contacts between the European Commission services

and Member States will take place. Candidate laboratories must contact their Member States

for information.

12. Submission of an application following this call implies acceptance by the candidate

laboratory and Member State of all provisions and conditions stipulated in this call.

13. The European Commission services will not reimburse any expenses incurred in preparing

and submitting applications.

2.2 Modalities applicable in case of the expression of interest by a consortium

For the purpose of this call, a "consortium" is defined as 'two or more entities in one or more

Member States working together to perform the EU reference laboratory tasks for the same

category or categories of devices, as referred to in Annex I of the call'. Individual consortium

members may cover some of the groups within the category. The consortium as a whole must

cover the entire selected category or categories.

Specific requirements for consortia in addition to the ones foreseen for single entities:

1. A single application must be submitted for a consortium. In case the entities are located in

different EU Member States, the application must be submitted jointly by all relevant

Member States.

2. Each member of the consortium must meet all selection criteria.

3. The consortium must nominate a coordinator who will be the leading entity and general

contact point.

4. Consortium members must authorise the coordinator to represent the consortium on their

behalf.

9

5. Consortium members must authorise the coordinator to receive and distribute possible

financial contributions received from the European Commission according to a distribution

key agreed among consortium members, which will be described in the work programme.

6. Each member of the consortium must include in the application an accession letter with the

following:

• confirmation of its participation in the consortium;

• indication of the specific area of participation;

• statement as to which entity has been nominated as the coordinator of the consortium;

• indications that the authorisations referred to in points 4 and 5 above have been granted.

7. Each member of the consortium must submit all documents requested for the selection

criteria as part of the single application.

8. For the preference criteria only, the consortium must submit a single jointly elaborated set

of documents. The work programme of the consortium has to contain a demonstration of

coherence and complementarity within the consortium members including task division,

decision-making process and the exchange of knowledge.

9. Technical liability: the consortium members are jointly and severally liable for carrying out

the tasks of the EU reference laboratory. If a consortium member fails to implement its part

of the tasks, the other members become responsible for implementing this part.

10. Financial liability: the consortium members maintain individual financial liability.

3 SELECTION CRITERIA

Candidate laboratories must satisfy the following selection criteria as demonstrated by the

corresponding means of proof and supporting documents.

No Criterion Means of proof

1 The candidate laboratories must document

and justify the knowledge and experience

requirements for staff, including the

director, the scientific and the technical

staff, needed to fulfil the EU reference

laboratory tasks in the scope of

designation.

1.1 List of knowledge and experience

requirements and the justification

thereof for the director, the scientific

staff and the technical staff, and any

relevant sub-categories of staff if the

candidate deems this necessary

2 The candidate laboratories must have staff

that fulfils the requirements referred to in

point 1.1 and document how those

requirements are fulfilled.

2.1 Overview tables for knowledge and

experience of staff referred to in

Annex III and the numbered

supporting documents

3 The candidate laboratories must have a

sufficient number of staff in relation to the

volume of the tasks they are to carry out.

3.1 Estimate of minimum capacity of the

candidate laboratory for task

referred to in Article 100(2) (a) of

Regulation (EU) 2017/746 (number

of notified body requests processed

10

per year per device group referred to

in Annex I, see template in Annex

IV)

3.2 Estimate of minimum capacity of the

candidate laboratory for task

referred to in Article 100(2) (b) of

Regulation (EU) 2017/746 (number

of notified body requests processed

per year per device group referred to

in Annex I, see template in Annex

IV)

3.3 Justification of the number of staff to

cover the above capacities and the

other tasks of EU reference

laboratories referred to in Article

100(2) of Regulation (EU) 2017/746

4 The candidate laboratories must put in

place a continuous training and education

programme for their staff.

4.1 Description of the continuous

training and education programme

for staff

5 The candidate laboratories must possess

the equipment, including specimens and

control materials, and sufficient quantity

of reference materials, necessary to carry

out the tasks in the scope of designation of

the EU reference laboratory.

5.1 Justification as to which equipment

and reference materials are

necessary to carry out the tasks

within the proposed scope of

designation. The justification must

also cover specimens and control

materials

5.2 Evidence that the candidate

laboratory possesses the equipment

referred to in point 5.1 and a

sufficient quantity of the reference

materials referred to in that point

5.3 A plan for the procurement of the

specimens, control materials and

reference materials referred to in

point 5.1

6 The candidate laboratories must have up-

to-date documentation on international

standards and best practices that apply to

the tasks within their proposed scope of

designation.

6.1 A list of international standards and

best practices, including common

specifications, that apply to the tasks

within the proposed scope of

designation, and justification of their

relevance

6.2 Evidence that the laboratory has

integrated the international

standards and best practices

referred to in point 6.1 into the

operating procedures for the

relevant tasks

11

7 The candidate laboratories must identify at

least one person within their management

as having overall responsibility for the

performance of the tasks set out in Article

100(2) of Regulation (EU) 2017/746.

7.1 Identification of the person having

overall responsibility for the

performance of the tasks set out in

Article 100(2) of Regulation (EU)

2017/746

8 The candidate laboratories must have

sufficient administrative staff to provide

the necessary administrative support for

performance of the tasks set out in Article

100(2) of Regulation (EU) 2017/746, in

relation to the volume of those tasks.

8.1 Estimate of the expected volume of

administrative work related to the

tasks referred to in Article 100(2) of

Regulation (EU) 2017/746

8.2 Justification of the number of

administrative staff to cover the

volume of work referred to in point

8.1

9 The candidate laboratories must have an

appropriate administrative organisation

and structure.

9.1 Evidence of the laboratory’s status

as a legal entity

9.2 If the laboratory is part of a larger

organisation, a description of the

activities of that organisation, its

organisational structure and

governance

9.3 If the laboratory is, directly or

indirectly, controlled by other

entities, the identity of such entities

and their controlling position

9.4 A description of the laboratory’s

internal organisational structure

with clearly allocated

responsibilities and reporting lines

9.5 A description of its operating

procedures including management

and performance of tasks,

management of staff, a staff

substitution plan, as well as

registration of documentation and

correspondence with external

entities

9.6 Evidence of its sources of funding

9.7 Declaration that none of the

exclusion situations referred to in

Article 136 of Regulation (EU,

Euratom) 2018/10466 apply to the

6 Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the

financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No

1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No

223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No

966/2012

12

candidate laboratory (template in

Annex V)

9.8 Evidence of economic viability

without financial assistance from the

Union, including:

9.8.1 Economic viability template in

Annex VI B

9.8.2 Balance sheets, profit and loss

accounts or annual reports for

the last three financial years

9.8.3 Where available, audits

reports from the last three

financial years

9.9 Proposed system for detailed

records of the calculation of the costs

and the corresponding fees levied

(for the tasks that may be covered by

fees)

10 The candidate laboratories must have a

confidentiality policy and put in place and

document measures to ensure that the staff

complies with the confidentiality policy.

10.1 Confidentiality policy including the

following:

10.1.1 the type of information that

shall be considered

confidential;

10.1.2 rules for the appropriate

secure handling, storage

and processing of

confidential information

and measures to prevent

undue disclosure;

10.1.3 rules for sharing of

confidential and non-

confidential information

with staff, and the public;

10.1.4 rules for granting access to

confidential information to

a competent authority of a

Member State upon its

request in the context of

market surveillance or

vigilance activities by the

competent authority;

10.1.5 rules for sharing

confidential information, on

the initiative of the EU

reference laboratory, with a

competent authority of a

Member State and with the

13

European Commission

where the EU reference

laboratory has reason to

believe that such sharing is

in the interest of protection

of public health.

10.2 List of measures to ensure that the

staff complies with the

confidentiality policy

11 The candidate laboratories must have the

confirmation of their respective Member

State that they will perform their tasks as

EU reference laboratories in the public

interest and in an independent manner

within their proposed scopes of

designation.

11.1 Confirmation by the Member State

that the candidate laboratory will

perform its tasks as the EU reference

laboratory in the public interest and

in an independent manner within the

proposed scope of designation

(template in Annex XI)

12 The candidate laboratories must have a

policy to ensure that the members of their

staff do not have financial or other interests

in the in vitro medical device industry,

which could affect their impartiality with

regard to the performance of their tasks.

12.1 Policy for the management of

conflict of interest of laboratory

staff, including steps to prevent,

identify and resolve conflicts of

interest

13 If designated, the candidate laboratory

must not be the designer, manufacturer,

supplier, installer, purchaser, owner or

maintainer of devices within its scope of

designation, nor the authorised

representative of any of those parties and

shall not be involved in the design,

manufacture or construction, marketing,

installation, use or maintenance of the

devices within its scope of designation.

If designated, the candidate laboratory

must not act as a notified body for devices

within its scope of designation.

If designated, the candidate laboratory

must not perform any tasks related to

conformity assessment under Regulation

(EU) 2017/746 on request by a notified

body, other than the tasks referred to in

Article 100(2) of Regulation (EU)

2017/746.

If designated, the candidate laboratory

must not enter into collaboration with a

device manufacturer or a notified body

concerning a joint commercial exploitation

if such collaboration falls within its scope

of designation.

13.1 A declaration as follows (template

in Annex VII):

13.1.1 if designated, the candidate

laboratory will not be the

designer, manufacturer,

supplier, installer,

purchaser, owner or

maintainer of devices within

the proposed scope of

designation, nor the

authorised representative of

any of those parties;

13.1.2 if designated, the candidate

laboratory will not be

involved in the design,

manufacture or

construction, marketing,

installation, use or

maintenance of the devices

within the proposed scope of

designation;

13.1.3 if designated, the candidate

laboratory will not be a

notified body for devices

within the proposed scope of

designation;

14

13.1.4 if designated, the candidate

laboratory will not perform

any tasks related to

conformity assessment

under Regulation (EU)

2017/746 on request of a

notified body, other than the

tasks referred to in Article

100(2) of Regulation (EU)

2017/746, within the scope

of designation of the

laboratory.

13.1.5 if designated, the candidate

laboratory will not enter

into collaboration with a

device manufacturer or a

notified body concerning a

joint commercial

exploitation, if such

collaboration falls within

the scope of its designation.

14 In case the candidate laboratory already

foresees outsourcing of testing to an

external laboratory according to Article 7

of the Commission Implementing

Regulation (EU) 2022/944.

If applicable:

14.1 A list of requirements set by the

candidate laboratory regarding the

competence for fulfilling the tasks

covered by the contract, including

staff and equipment

14.2 Declaration by the candidate

laboratory that the external

laboratory:

14.2.1 satisfies the requirements in

point 14.1

14.2.2 has in place and documents

the measures referred to in

point 10.2 regarding

confidentiality policy;

14.2.3 confirms the absence of

conflict of interest in

accordance with the policy

referred to in point 12.1 as

regards the activities

covered by the contract.

4 PREFERENCE CRITERIA

These additional criteria are intended to allow evaluating the scientific excellence of the

candidate laboratory. Up to 100 points may be awarded for the four criteria below.

15

Submission of the supporting documents for the preference criteria is not necessary at the initial

application stage. Candidate laboratories that are required to prepare this additional

documentation will be informed by their Member State at a later stage. The Annexes to be

completed will be provided together with the notification.

Criterion

Means of proof

15 Team composition (exceptional level

of experience and knowledge relevant

to the proposed scope of designation) –

up to 35 points

15.1 Key scientific publications (up to

10); references of research and other

activities of proposed EU reference

laboratory staff members, relevant

for the proposed scope of designation

and the tasks of an EU reference

laboratory

15.2 A justification as to why these

publications and activities show

excellence of the candidate

laboratory

16 Evidence of understanding of the

mission as a EU reference laboratory

and capacity to develop a work

program as an EU reference laboratory

– up to 35 points

16.1 A simulation of a Work Programme

of activities that could be undertaken

by the laboratory on its own initiative

(description of the activities,

objectives, expected outputs in line

with Articles 100(2) and 100(5) of

Regulation (EU) 2017/746) for three

years (maximum ten pages, assuming

a maximum budget of 200.000€ per

year, template in Annex XII to be

provided at a later stage in the

application process if necessary)

17 International collaboration – up to 15

points

17.1 Evidence of activities at

international level relevant for the

proposed scope of designation and

the tasks of an EU reference

laboratory, e.g. involvement and

participation in international

standardisation activities and

networks (e.g. CEN, ISO),

involvement and participation in

other multinational activities (e.g.

research projects), reliable and

proven procedures for dispatching

and receiving relevant materials

from manufacturers, laboratories,

hospitals situated in the EU & third

countries (e.g. batches, samples,

infectious material for diagnostic

and research purposes)

16

18 Coordination – up to 15 points 18.1 Evidence of coordination activities

e.g. organisation of conferences,

workshops, training activities etc.,

close working relations with other

laboratories in the same area of

competence

5 SELECTION

For each scope of designation, the applications selected will be the ones that comply with the

selection criteria and, collectively, cover the estimated minimum EU-wide capacity as referred

to in Annex I. In case of evaluation of the preference criteria, the applications selected will be

the ones with the highest score.

Cover letter 2nd call EURLs Regulation (EU) 2017 746.pdf

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.DDG1.D.3/OT/

Subject: Call for applications for designation of EU reference laboratories in

the field of in vitro diagnostic medical devices

Your Excellency,

I am pleased to inform you that, with this letter, the Directorate General for Health

and Food Safety is formally launching a call for applications for designation of EU

reference laboratories (EURLs) in the field of in vitro diagnostic medical devices,

under Regulation (EU) 2017/746. The call will be run in two waves and covers

various categories of devices of risk class D.

I would be grateful if you could forward the attached documentation to all relevant

authorities in your country. I would like to draw your attention to the fact that

applications must be submitted by the Member States.

Let me stress that the requirements in the call must be strictly complied with,

including the deadlines for submission of applications.

I look forward to the possible submission of applications for candidate EURLs by

your country.

Please contact the following e-mail addresses: [email protected]; SANTE-

[email protected] for further information (subject: Call for applications for

designation of EURLs). For technical assistance during the submission of

applications, please send an email to: [email protected].

For background, this is the second call for EURLs under Regulation (EU) 2017/746.

The first call was carried out in 2022, following which five EURLs were designated

covering the following categories of class D devices: detection or quantification of

markers of hepatitis and retroviruses, herpesviruses, bacterial agents and respiratory

viruses that cause life-threatening diseases. More information can be found here: https://health.ec.europa.eu/medical-devices-vitro-diagnostics/eu-reference-

laboratories-eurls_en

Yours faithfully,

2

Sandra GALLINA

By email to:

Permanent Representations of all EU Member States

Missions of Norway, Iceland, Liechtenstein and Turkey to the EU

Copy to:

Members and observer countries of the Medical Device Coordination Group

Enclosure: Call for applications for designation of EU reference laboratories in

the field of in vitro diagnostic medical devices, with 12 annexes

E-kiri.eml

Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.
Tundmatu saatja korral palume linke ja faile mitte avada.

Tere!

Edastan Komisjoni kirja, registreeritud EV AEEL juures 18.02.2025, nr 10.2-11/140.

Parimate soovidega

Tiiu Noobel

Sekretär

Eesti Vabariigi alaline esindus EL juures

Rue Guimard 11/13, 1040 Brüssel

Tel: + 32 2227 4337, tiiu.noobel@mfa.ee

https://eu.mfa.ee/et/

From: Esindus EL juures üldaadress <[email protected]>
Sent: Tuesday, February 18, 2025 9:42 AM
To: Tiiu Noobel <[email protected]>
Subject: FW: Call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices - Ares(2025)1258969

From: [email protected] <[email protected]>
Sent: Monday, February 17, 2025 7:39 PM
To: Marten Kokk <[email protected]>
Cc: Esindus EL juures üldaadress <[email protected]>; Agne Nettan-Sepp <[email protected]>; Kadi Avingo <[email protected]>
Subject: Call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices - Ares(2025)1258969

Your Excellency,

On behalf of Sandra Gallina, please find enclosed the formal launch of a call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

Looking forward to the possible submission of applications for candidate EURLs by your country .

Yours sincerely,

SANTE Medical devices