ED Decision 2024/002/R Design or production organisations of ATM/ANS equipment

Annex to ED Decision 2024/002/R Page 1 of 12

Acceptable Means of Compliance and Guidance Material for the technical

requirements and administrative procedures for the organisations involved in the design or production of air traffic management/air navigation services systems and air traffic

management/air navigation services constituents

AMC & GM to Annex II (Part-DPO.OR) to Commission Implementing Regulation (EU)

2023/1769

Issue 1

22 March 20241

1 For the date of entry into force of this Issue, kindly refer to ED Decision 2024/002/R at the Official Publication of EASA.

AMC & GM to Part-DPO.OR — Issue 1

Annex to ED Decision 2024/002/R Page 2 of 12

Table of contents

Acceptable Means of Compliance and Guidance Material for the technical requirements and administrative procedures for the organisations involved in the design or production of air traffic management/air navigation services systems and air traffic management/air navigation services constituents ................................................................................................................................. 1

AMC & GM to Annex II (Part-DPO.OR) to Commission Implementing Regulation (EU) 2023/1769 ... 1

AMC1 DPO.OR.A.010(a) Application for a design or production organisation approval and demonstration of capability ............................................................................................................ 3 AMC1 DPO.OR.A.045(a)(1) Failures, malfunctions, and defects ..................................................... 3 GM1 DPO.OR.A.045(a)(1) Failures, malfunctions, and defects ....................................................... 3 GM1 DPO.OR.A.045(c) Failures, malfunctions, and defects ............................................................ 3 GM1 DPO.OR.A.045(c);(d) Failures, malfunctions and defects ....................................................... 4 AMC1 DPO.OR.A.045(e) Failures, malfunctions and defects .......................................................... 4 GM1 DPO.OR.B.001 Management system ...................................................................................... 5 GM1 DPO.OR.B.001(a) Management system .................................................................................. 5 AMC1 DPO.OR.B.001(c) Management system ................................................................................ 5 AMC1 DPO.OR.B.005(b) Change management ............................................................................... 6 GM1 DPO.OR.B.005(b) Change management ................................................................................. 7 GM2 DPO.OR.B.005(b) Change management ................................................................................. 8 GM3 DPO.OR.B.005(b) Change Management ................................................................................. 8 AMC1 DPO.OR.B.015 Contracted activities ..................................................................................... 8 AMC2 DPO.OR.B.015 Contracted activities ..................................................................................... 9 GM1 DPO.OR.B.015 Contracted activities ....................................................................................... 9 AMC1 DPO.OR.C.001(b) Organisations involved in the design or production of ATM/ANS equipment ....................................................................................................................................... 9 AMC1 DPO.OR.C.001(c) Organisations involved in the design or production of ATM/ANS equipment ..................................................................................................................................... 10 GM1 DPO.OR.C.001(c) Organisations involved in the design or production of ATM/ANS equipment ..................................................................................................................................... 10 AMC1 DPO.OR.C.001(d) Organisations involved in the design or production of ATM/ANS equipment ..................................................................................................................................... 11 GM1 DPO.OR.C.001(d) Organisations involved in the design or production of ATM/ANS equipment ..................................................................................................................................... 11 AMC1 DPO.OR.C.001(e) Organisations involved in the design or production of ATM/ANS equipment ..................................................................................................................................... 11

AMC & GM to Part-DPO.OR — Issue 1

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AMC1 DPO.OR.A.010(a) Application for a design or production organisation approval and demonstration of capability

FORM

The dedicated EASA application form (FO.AOA.00085) should be obtained from the EASA website2 and

completed and signed by the accountable manager of the design or production organisation (DPO).

The completed form should be submitted to EASA, accompanied by a copy of the organisation

exposition and the company’s registration, in accordance with the instructions included in the form.

AMC1 DPO.OR.A.045(a)(1) Failures, malfunctions, and defects

COLLECTION, INVESTIGATION AND ANALYSIS OF OCCURRENCES

The ‘collection’, ‘investigation’ and ‘analysis’ functions of the DPO’s reporting system should include

means to:

— analyse occurrences, and related available information;

— identify adverse trends;

— investigate associated root cause(s); and

— establish any necessary corrective action(s).

GM1 DPO.OR.A.045(a)(1) Failures, malfunctions, and defects COLLECTION FUNCTION

The word ‘collection’ refers to the setting up of procedures which will enable relevant failures,

malfunctions and defects or other occurrences to be properly collected when they occur.

As the collection system needs to accept reports that originate outside the organisation (from

ATM/ANS providers, suppliers, etc.), it is necessary to inform possible reporters of the existence of

the DPO’s reporting system and the appropriate means to submit reports into it. This does not

presume that direct access to the system is to be granted if other mechanisms are more appropriate.

GM1 DPO.OR.A.045(c) Failures, malfunctions, and defects

REPORTING TO EASA

The reporting process could include:

— a description of the applicable requirements for the reporting;

— a description of the reporting mechanism, including forms, means and deadlines;

— the personnel responsible for reporting.

2 https://www.easa.europa.eu/en/document-library/application-forms/foaoa00085

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GM1 DPO.OR.A.045(c);(d) Failures, malfunctions and defects REPORTING TO EASA — ‘AWARE’

The reference to being ‘aware’ of an occurrence implies that the organisation identifies the event as

one that falls into the category of occurrences to be reported. The 72-hour period starts when the

possible unsafe condition is identified by the DPO.

AMC1 DPO.OR.A.045(e) Failures, malfunctions and defects

FOLLOW-UP AND CLOSURE OF REPORTED OCCURRENCES

(a) The organisation should transmit the following information to EASA within 30 days from the

date of notification of the occurrence to EASA:

(1) the latest position of the organisation responsible for design as to whether an unsafe,

insecure or under-performing condition is confirmed;

(2) the results of the occurrence analysis and of the first investigation — including the

cause(s) of the occurrence and missing information, if known; and

(3) the measures it has taken, intends to take or proposes to take, including an assessment

evaluating whether the product can be operated safely until the corrective action is

defined and implemented, or that immediate mitigation measures need to be

implemented until a more refined assessment can be provided.

(b) The final (close-out) report, as soon as available and, in principle, no later than 3 months after

the occurrence notification, should include:

— the final position of the organisation involved in the design as to whether an unsafe,

insecure or under-performing condition exists;

— the results of the occurrence analysis and of the final investigation — including the

cause(s) of the occurrence and missing information;

— any corrective and preventive measures taken by the reporting organisation; and

— an assessment evaluating whether these corrective and preventive measures allow the

product to be operated as intended.

(c) Notwithstanding point (a), when the organisation identifies that no unsafe, insecure or under-

performing condition exists as a result of their analysis of a voluntarily reported occurrence, it

can delay further communication to EASA up to the issuance of the final report and report the

occurrence as closed upon issue (data exchange). In such cases, no follow-up report should be

submitted. The final report to EASA should include confirmation and justification that no unsafe,

insecure or under-performing condition exists. The organisation is requested to provide

information on the cause(s) of the occurrence and on the corrective or preventive measures

that were taken by the organisation.

This way of reporting should not be understood as an accepted deviation from the applicable

requirements. If, at any stage during the investigation, the organisation identifies that a possible

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unsafe, insecure or under-performing condition exists, it should be communicated to EASA via

a mandatory report within 72 hours.

GM1 DPO.OR.B.001 Management system QUALITY MANAGEMENT ELEMENTS OF THE MANAGEMENT SYSTEM — ISO 9001

CERTIFICATE

An ISO 9001 certificate, relevant to the scope of the approval being requested, issued by an

appropriately accredited organisation, covers some quality management elements of the

management system, but it does not address other system engineering and safety processes required

by this Regulation. EASA may accept ISO 9001 certificates as evidence during compliance

investigations for those elements covered. Other elements required by this Regulation in reference to

the management system that are not covered by the ISO 9001 certificate issued by an appropriately

accredited organisation will be subject to oversight by EASA.

GM1 DPO.OR.B.001(a) Management system

The management system should include:

(a) an organisational structure to:

(1) control the design, including demonstration of compliance with the applicable detailed

specifications;

(2) independently check demonstrations of compliance;

(3) liaise with EASA;

(4) continuously evaluate the organisation;

(5) manage contracted activities;

(b) procedures and responsibilities associated with the functions listed above, taking due account

of the requirements applicable to design and approval of changes to ATM/ANS equipment

design.

AMC1 DPO.OR.B.001(c) Management system

COMPLIANCE MONITORING

(a) The monitoring of compliance of the management system with the applicable requirements and

the adequacy of the established procedures should be performed by systematic means. These

systematic means of compliance monitoring may include structured experience exchanges,

regular design meetings, brainstorming or lessons-learned sessions, project reviews at

appropriate phases of the development, or other similar means.

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Annex to ED Decision 2024/002/R Page 6 of 12

(b) Audits should be one element of compliance monitoring. When implemented, audits should be

conducted as combined process/product (project) audits that focus on the implemented key

processes or methods practised. In addition, audits should also allow the design or production

organisation to find ways to become more efficient by continuous improvement.

AMC1 DPO.OR.B.005(b) Change management

PROCEDURE TO MANAGE CHANGES TO ATM/ANS EQUIPMENT

(a) A procedure should be established for the classification and approval of design changes to the

ATM/ANS equipment. The procedure should define criteria for classifying a change as minor or

major, taking into account points ATM/ANS.EQMT.CERT.020 and ATM/ANS.EQMT.DEC.020 of

Delegated Regulation (EU) 2023/1768, and the following key aspects:

(b) The change is classified as major when:

(1) the change includes one of the following evolutions:

(i) new concept of operation of the equipment;

(ii) new technologies or techniques used in the ATM/ANS equipment development

(e.g. used in design or verification);

(iii) changes to the ATM/ANS equipment that could significantly impact its functions

and its reverification;

(iv) changes to the software that significantly impact a software function and induce

subsequent reverification and reinvestigation;

(v) changes to the hardware that significantly impact a hardware function and induce

subsequent reverification and reinvestigation; or

(vi) modified ATM/ANS equipment architecture

(2) the change introduces the need to add requirements to or remove requirements from:

(i) the previously approved certification basis (for ATM/ANS equipment subject to

certification); or

(ii) the detailed specifications referred to in the declaration (for ATM/ANS equipment

subject to declaration of design compliance); for instance, addition or removal of

a function addressed in the detailed specifications;

(3) the change introduces a new limitation to or a new deviation from:

(i) the previously approved certification basis (for ATM/ANS equipment subject to

certification); or

(ii) the detailed specifications referred to in the declaration (for ATM/ANS equipment

subject to declaration of design compliance); and

(4) the change introduces a new or modified means of compliance used by the DPO, not

previously investigated by EASA, to demonstrate compliance with the certification basis

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(for ATM/ANS equipment subject to certification) or with detailed specifications referred

to in the declaration (for ATM/ANS equipment subject to declaration of design

compliance).

(c) The procedure for change management should be defined in coordination with the procedure

for configuration of the ATM/ANS equipment, i.e. the part numbering system of DPO equipment

should incorporate how minor changes will be reflected in the configuration of the equipment,

and more particularly in the part number structure. In the case of a major change, a new model

designation / part number may need to be defined.

(d) Minor changes should be processed in accordance with the privileges of the approved DPO. For

minor changes, the approved DPO should:

(1) record the change description and the justification for the change classification;

(2) update all related technical documents including the user manual;

(3) record continuous compliance with the ATM/ANS equipment certificate or ATM/ANS

equipment declaration of design compliance;

(4) notify EASA of the minor changes. When the change is managed in accordance with the

change management procedure approved by EASA, the notification can be sent after the

change is introduced.

(e) Major changes should be notified to EASA prior to their introduction by submission of one of

the following:

(1) an application for the issue of a new certificate, in accordance with point

ATM/ANS.EQMT.CERT.020 of Implementing Regulation (EU) 2023/1768, for ATM/ANS

equipment subject to Article 4 of that Regulation; or

(2) a new declaration of design compliance, in accordance with point

ATM/ANS.EQMT.DEC.020(b) of Implementing Regulation (EU) 2023/1768, for ATM/ANS

equipment subject to Article 5 of that Regulation.

GM1 DPO.OR.B.005(b) Change management GENERAL

When performing changes to ATM/ANS equipment, a change impact analysis is performed to assess

and document the impact of the change on the requirements, design, verification and its associated

life cycle data, used for demonstration of compliance.

The communication regarding major changes to ATM/ANS equipment will indicate:

(a) the description of the change;

(b) the impact on the equipment and its associated life cycle data for demonstration of compliance;

(c) the impact on the demonstration of compliance with the EASA applicable detailed specifications

and certification basis, identifying in particular:

(1) the compliance demonstration with any new detailed specifications, not subject to the

initial certificate or declaration;

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(2) any new limitations;

(3) any new deviations;

(4) changes in the means of compliance with the applicable detailed specifications; and

(d) the proposed EASA level of involvement, in the case of ATM/ANS equipment subject to

certification.

GM2 DPO.OR.B.005(b) Change management REACTION BY THE DPO TO AN UNPLANNED (MAJOR) CHANGE

The procedure may also include the process for the reaction by the DPO to an unplanned (major)

change that may arise with the need for urgent action that would normally require prior approval by

the Agency.

GM3 DPO.OR.B.005(b) Change Management CASES IN WHICH THE DPO REACTS TO AN UNPLANNED (MAJOR) CHANGE

The cases in which the DPO reacts to an unplanned (major) change usually are when the DPO responds

immediately to a safety, security or interoperability problem or when an emergency situation arises

in which the DPO has to take immediate action (e.g. security patches) to ensure the safety, security or

interoperability of its equipment in operation.

AMC1 DPO.OR.B.015 Contracted activities

DPO RESPONSIBILITY WHEN CONTRACTING ACTIVITIES

(a) A DPO, responsible for ensuring that the design of the ATM/ANS equipment complies with the

applicable certification basis requirements or detailed specifications used for the declaration of

design compliance, as applicable, should ensure that components designed, or tasks performed,

by external parties are acceptable. To discharge this responsibility, the DPO should implement

documented methods that ensure the compliance of the finished (ready to be delivered)

ATM/ANS equipment, and that make use of these components or task results, prior to issuing

the final EASA release form.

(b) As the responsibility for verification of compliance remains with the DPO, no specific

qualification measures are required other than to pragmatically verify the capabilities of the

external party, and to ensure that the required level of detail is met to enable the task results

to be adequately verified.

(c) If a DPO subcontracts the compliance monitoring function to an external party that conducts

the task, but does not hold its own DPO approval, then the same requirements for the

qualification, nomination and documentation apply to the person who is nominated and

indicated in the DPO handbook of the contracting DPO.

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(d) Alternatively, if an organisation with a DPO approval obtains design substantiation data from a

subcontractor that also holds a DPO approval, and the work that is conducted is within the

approved scope of this subcontractor DPO, the subcontractor’s design data becomes acceptable

when the contracting DPO has verified that the results adequately meet the needs of the

ATM/ANS equipment under development. Additional formal compliance verification by the

contracting DPO is not required if the person responsible for compliance verification of the

contracted DPO signs and approves the document under its DPO approval.

AMC2 DPO.OR.B.015 Contracted activities

RESPONSIBILITY WHEN CONTRACTING ACTIVITIES

(a) A contract should exist between the DPO and the contracted organisation clearly defining the

contracted activities and the applicable requirements.

(b) The contracted activities, performed by an organisation that is not itself approved in accordance

with this Regulation to carry out such activity, should be included in the DPO’s oversight

process.

(c) A DPO should ensure that the contracted organisation has the necessary authorisation,

declaration or approval when required, and commands the resources and competence to

undertake the task.

GM1 DPO.OR.B.015 Contracted activities

RESPONSIBILITY WHEN CONTRACTING ACTIVITIES

Regardless of the approval status of the contracted organisation, the DPO is responsible for ensuring

that all contracted activities are subject to compliance monitoring.

AMC1 DPO.OR.C.001(b) Organisations involved in the design or production of ATM/ANS equipment

DESIGN ACTIVITIES

(a) Specifying, developing, and testing the ATM/ANS equipment before production should be

considered design activities.

(b) When components designed by contracted organisations are integrated into the ATM/ANS

equipment, design activities by the DPO should also include the requirements specification

(functional, performance, interfaces, adaptation) of these components at the level of their

integration and corresponding verifications to ensure the overall compliance.

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AMC1 DPO.OR.C.001(c) Organisations involved in the design or production of ATM/ANS equipment

PRODUCTION ACTIVITIES

The following should be considered production activities:

(a) manufacturing/acquisition;

(b) conformance to design data;

(c) release process; and

(d) delivery to customers.

GM1 DPO.OR.C.001(c) Organisations involved in the design or production of ATM/ANS equipment PRODUCTION ACTIVITIES

Figure 1 — Production activities

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AMC1 DPO.OR.C.001(d) Organisations involved in the design or production of ATM/ANS equipment

EASA RELEASE FORM

(a) An EASA release form should be issued for ATM/ANS equipment produced by the DPO as per

the organisation’s scope of work relevant to the terms of approval.

(b) Each organisation involved in the production of ATM/ANS equipment subject to conformity

assessment under this Regulation should issue a statement of conformity regarding its

production, using an EASA release form (see AMC1 DPO.OR.C.001(e)). This statement should be

signed by an authorised person involved in the production of the ATM/ANS equipment.

(c) An EASA release form should contain a statement that:

(1) the finished (ready to be delivered) ATM/ANS equipment conforms to the approved

design data of the ATM/ANS equipment subject to certification or declaration in

accordance with Article 4 or Article 5 of Delegated Regulation (EU) 2023/1768

respectively;

(2) the ATM/ANS equipment has been manufactured in compliance with Implementing

Regulation (EU) 2023/1769.

GM1 DPO.OR.C.001(d) Organisations involved in the design or production of ATM/ANS equipment EASA RELEASE FORM

The term ‘produced’ should be considered as ‘released’ for ATM/ANS equipment that has a software

component.

AMC1 DPO.OR.C.001(e) Organisations involved in the design or production of ATM/ANS equipment

EASA RELEASE FORM | STANDARD FORM

ATM/ANS EQUIPMENT RELEASE FORM

1. DPO reference 2. Statement ref No:

3. ATM/ANS equipment serial number

4. ATM/ANS equipment model name

5. Part number 6. Certificate ref No: / Declaration ref No:

7. Description of the ATM/ANS equipment

8. Concessions

9. Exemptions, waivers or derogations

10. Remarks

11. Statement of Conformity

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It is hereby certified that this ATM/ANS equipment conforms fully to the certificated design/the declaration of design compliance and to the items above in boxes 7, 8, 9 and 10. The ATM/ANS equipment is manufactured in compliance with Implementing Regulation (EU) 2023/1769.

12. Signed 13. Name 14. Date (d/m/y)

15. DPO Approval Reference

Block 1: The full name and the address of the location of the DPO that issues the statement. This block

may be preprinted. Logos, etc. are permitted if the logo, etc. can be contained within the block.

Block 2: A unique form tracking number established by the numbering system/procedure of the DPO

must be indicated.

Block 3: The serial number identification linked to a specific item assigned by the organisation involved

in the production for control and traceability and product support purposes.

Block 4: The ATM/ANS equipment model name in full as specified in the certificate or declaration of

design compliance.

Block 5: The part number identification of the ATM/ANS equipment, as it appears on the equipment

marking, and on the certificate/declaration of design compliance.

Block 6: Reference to the certificate or declaration of design compliance reference numbers for the

subject ATM/ANS equipment.

Block 7: Brief description of the ATM/ANS equipment, including its main functionalities.

Block 8: Unintentional differences from the approved design, referred to as ‘concessions’.

Block 9: Only agreed3 exemptions, waivers or derogations may be included here.

Block 10: Any statement, information, particular data or limitation which may affect the compliance

of the ATM/ANS equipment. If there is no such information or data, state ‘NONE’. List the design

changes to the ATM/ANS equipment, under approved design data, and reference all the applicable

ATM/ANS equipment directives (or equivalent) that have been applied on the equipment.

Block 11: The validity of the EASA release form is subject to the full completion of all the blocks on the

form.

Block 12: The EASA release form is signed by an authorised person.

Block 13: The name of the person that signs the statement.

Block 14: The date on which the EASA release form is signed should be given.

Block 15: The EASA DPO approval reference should be quoted.

3 ‘agreed’ refers to agreement between the approved DPO and EASA.

ED Decision 2024/002/R

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An agency of the European Union

Executive Director Decision

2024/002/R

of 22 March 2024

issuing the following:

Issue 1 of the Acceptable Means of Compliance and Guidance Material

to Annex II (Part-DPO.OR) of Commission Implementing Regulation (EU) 2023/1769

‘AMC & GM to Part-DPO.OR — Issue 1’

— — —

‘Design or production organisations of ATM/ANS equipment’

THE EXECUTIVE DIRECTOR OF THE EUROPEAN UNION AVIATION SAFETY AGENCY (EASA),

Having regard to Regulation (EU) 2018/11391, and in particular Articles 76(3) and 104(3)(a) thereof,

Whereas:

(1) Acceptable means of compliance are non-binding standards issued by EASA, which are used by

persons and organisations to show compliance with Regulation (EU) 2018/1139 and with the

delegated and implementing acts adopted on the basis thereof.

(2) Guidance material is non-binding material issued by EASA, which helps to illustrate the meaning

of delegated or implementing acts or certification specifications and detailed specifications, and

which is used to support the interpretation of Regulation (EU) 2018/1139, of the delegated and

implementing acts adopted on the basis thereof, and of certification specifications and detailed

specifications.

(3) Commission Implementing Regulation (EU) 2023/17692 of 12 September 2023 lays down

technical requirements and administrative procedures for the approval of organisations

involved in the design or production of air traffic management/air navigation services systems

1 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of

civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1) (https://eur- lex.europa.eu/legal-content/EN/TXT/?qid=1535612134845&uri=CELEX:32018R1139).

2 OJ L 228, 15.9.2023, p. 19.

ED Decision 2024/002/R

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An agency of the European Union

and constituents. Annex II (Part-DPO.OR) establishes the common requirements as regards the

rights and obligations of an applicant for, and a holder of, an organisation approval for the

design or production of ATM/ANS equipment.

(4) EASA shall, pursuant to Article 4(1)(a) of Regulation (EU) 2018/1139, reflect the state of the art

and the best practices in the field of aviation, taking into account worldwide aviation experience

and scientific and technical progress in the respective fields.

This Decision issues the acceptable means of compliance and guidance material to facilitate the

application of Commission Implementing Regulation (EU) 2023/1769.

(5) EASA, pursuant to Article 115(1)(c) of Regulation (EU) 2018/1139 and Article 6 of the EASA

Rulemaking Procedure3, widely consulted the interested parties on the content of this Decision,

considered the comments received, and provided thereafter a written response to the

comments received through the consultation4,

HAS DECIDED:

Article 1

The Acceptable Means of Compliance and Guidance Material to Annex II (Part-DPO-OR) to

Commission Implementing Regulation (EU) 2023/1769 are laid down in the Annex to this Decision.

Article 2

This Decision shall enter into force on the day following that of its publication in the Official Publication

of EASA.

Cologne, 22 March 2024

For the European Union Aviation Safety Agency

The Acting Executive Director

Luc TYTGAT

3 EASA is bound to follow a structured rulemaking process as required by Article 115(1) of Regulation (EU) 2018/1139.

Such a process has been adopted by the EASA Management Board (MB) and is referred to as the ‘Rulemaking Procedure’. See MB Decision No 01-2022 of 2 May 2022 on the procedure to be applied by EASA for the issuing of opinions, certification specifications and other detailed specifications, acceptable means of compliance and guidance material ('Rulemaking Procedure'), and repealing Management Board Decision No 18-2015 (https://www.easa.europa.eu/the- agency/management-board/decisions/easa-mb-decision-01-2022-rulemaking-procedure-repealing-mb).

4 http://easa.europa.eu/document-library/comment-response-documents

European Union Aviation Safety Agency

Explanatory Note to ED Decisions 2024/001/R and 2024/002/R

in accordance with Article 4(2) of MB Decision 01-2022

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An agency of the European Union

2nd set of acceptable means of compliance and guidance material supporting the new regulatory framework on the

conformity assessment of ATM/ANS systems and ATM/ANS constituents

Acceptable means of compliance and guidance material as regards organisations involved in

the design or production of ATM/ANS systems and ATM/ANS constituents

RMT.0161 (SUBTASK 3)

EXECUTIVE SUMMARY

These Decisions establish the acceptable means of compliance (AMC) and guidance material (GM) associated

with the applicable requirements on the approval of organisations involved in the design or production

(hereafter ‘DPOs’) of air traffic management/air navigation services systems and air traffic management/air

navigation services constituents (hereafter ‘ATM/ANS equipment’). These AMC & GM also complement the 1st

set of AMC & GM established with ED Decision 2023/016/R for the application of the conformity assessment

framework for ATM/ANS equipment.

Due to the novelty of the subject, it is important to provide the necessary means for demonstration of

compliance by the DPOs and for the application of the above-mentioned framework.

This regulatory material is expected to further facilitate the effective modernisation of the European air traffic

management network (EATMN), ensuring more streamlined conformity assessment mechanisms and

increased harmonisation and interoperability of ATM/ANS equipment brought to the EU market.

REGULATION(S) TO BE AMENDED/ISSUED

N/A

ED DECISIONS TO BE ISSUED/AMENDED/REPEALED — ED Decision 2023/016/R — AMC & GM to to the Articles of

Commission Delegated Regulation (EU) 2023/1768 — ED Decisions — AMC & GM to support the application of

Commission Delegated Regulation (EU) 2023/1768 and Commission Implementing Regulation (EU) 2023/1769

AFFECTED STAKEHOLDERS: Organisations involved in the design and/or production of ATM/ANS equipment, ATM/ANS

providers, national competent authorities (NCAs), and EASA.

WORKING METHODS

Development Impact assessment(s) Consultation

By EASA with external support Light NPA — Public Workshop — Focused

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Table of contents

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Table of contents

1. About these Decisions ............................................................................................. 3

2. In summary — why and what .................................................................................. 4

2.1. Why we need to act............................................................................................................ 4

2.2. What we want to achieve — objectives ............................................................................. 5

2.3. How we want to achieve it — overview of the Decisions .................................................. 5

2.3.1. Additional AMC & GM to Commission Delegated Regulation (EU) 2023/1768 ................. 6

2.3.2. AMC & GM to Commission Implementing Regulation (EU) 2023/1769 ............................ 6

2.4. What are the stakeholders’ views ...................................................................................... 7

3. Expected benefits and drawbacks of the regulatory material.................................... 8

4. Monitoring and evaluation ...................................................................................... 9

5. Proposed actions to support implementation ........................................................ 10

6. References............................................................................................................. 11

6.1. Related EU regulations ..................................................................................................... 11

6.2. Related EASA decisions .................................................................................................... 12

6.3. Other references .............................................................................................................. 12

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1. About these Decisions

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1. About these Decisions

The European Union Aviation Safety Agency (EASA) identified the need for certification or declaration

of certain ATM/ANS equipment as provided for in Regulation (EU) 2018/11391 (the EASA Basic

Regulation). Recognising that in the future the provision of ATM/ANS will rely more heavily on new

digital technologies and ATM/ANS systems than today, action at European Union level is required to

ensure the safety and interoperability of such systems. Moreover, ATM/ANS systems and ATM/ANS

constituents (hereafter ‘ATM/ANS equipment’) are key and integral elements of the European ATM

network (EATMN) and form a fundamental component to ensure safe flight operations within the

single European sky (SES) airspace (as described in Chapter 2). EASA published Opinion No 01/2023

on the basis of which the European Commission adopted the new conformity assessment framework

for ATM/ANS equipment.

This rulemaking activity is a subsequent step of the newly established framework for ATM/ANS

equipment. Due to the novelty of the subject, it is important to provide the necessary means for

demonstration of compliance by the DPOs and for the application of the above-mentioned recently

adopted framework.

EASA developed the regulatory material in question in line with the Basic Regulation and the

Rulemaking Procedure2, as well as in accordance with the objectives and working methods described

in the ToR for RMT.01613. EASA developed this regulatory material with the support of Rulemaking

Group (RMG) RMT.0161. Thereafter, the draft regulatory material was publicly consulted through NPA

2023-054 and through a focused consultation workshop held on 4 July 2023. Recognising the

importance of the timely implementation, EASA issued on 26 October 2023 the 1st set of the

associated Decisions with a view to effectively supporting the implementation of the new framework

addressing the detailed specifications (DSs) and the most essential set of AMC & GM related to

measures during the transitional period; in particular, this concerned the issue of statement of

compliance (SoC) by ATM/ANS providers and their oversight. The regulatory material introduced with

these Decisions constitutes the 2nd set of the stepped-approach publication. EASA reviewed the

comments received through the NPA consultation as well as those through the workshop and duly

considered them for the preparation of the regulatory material presented here.

1 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of

civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1) (https://eur- lex.europa.eu/legal-content/EN/TXT/?qid=1535612134845&uri=CELEX:32018R1139).

2 EASA is bound to follow a structured rulemaking process as required by Article 115(1) of Regulation (EU) 2018/1139. Such a process has been adopted by the EASA Management Board (MB) and is referred to as the ‘Rulemaking Procedure’. See MB Decision No 01-2022 of 2 May 2022 on the procedure to be applied by EASA for the issuing of opinions, certification specifications and other detailed specifications, acceptable means of compliance and guidance material ('Rulemaking Procedure'), and repealing Management Board Decision No 18-2015 (https://www.easa.europa.eu/the- agency/management-board/decisions/easa-mb-decision-01-2022-rulemaking-procedure-repealing-mb).

3 https://www.easa.europa.eu/document-library/terms-of-reference-and-group-compositions/tor-rmt0161 4 https://www.easa.europa.eu/en/document-library/notices-of-proposed-amendment/npa-2023-05

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2. In summary — why and what

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2. In summary — why and what

2.1. Why we need to act

The Basic Regulation lays down interoperability requirements for the EATMN and mandates the

development of the related delegated and implementing acts as regards the certification or

declaration of ATM/ANS equipment as well as of the organisations involved in their design,

production, and maintenance.

The interoperability Regulation (Regulation (EC) No 552/20045) was repealed by the Basic Regulation,

whose Article 139 establishes the transitional provisions whereby certain articles of said

interoperability Regulation and its Annexes III and IV remain applicable until the date of application of

the new framework, and in any case not later than 12 September 2023.

In this context, the new regulatory framework on the ATM/ANS equipment proposed with EASA

Opinion No 01/2023 was adopted by the European Commission. The new framework consists of five

Regulations:

— Commission Delegated Regulation (EU) 2023/17686 of 14 July 2023 laying down detailed rules

for the certification and declaration of air traffic management/air navigation services systems

and air traffic management/air navigation services constituents;

— Commission Implementing Regulation (EU) 2023/17697 of 12 September 2023 laying down

technical requirements and administrative procedures for the approval of organisations

involved in the design or production of air traffic management/air navigation services systems

and constituents and amending Implementing Regulation (EU) 2023/203;

— Commission Implementing Regulation (EU) 2023/17708 of 12 September 2023 laying down

provisions on aircraft equipment required for the use of the Single European Sky airspace and

operating rules related to the use of the Single European Sky airspace and repealing Regulation

(EC) No 29/2009 and Implementing Regulations (EU) No 1206/2011, (EU) No 1207/2011 and

(EU) No 1079/2012;

— Commission Implementing Regulation (EU) 2023/17719 of 12 September 2023 amending

Implementing Regulation (EU) 2017/373 as regards air traffic management and air navigation

services systems and constituents and repealing Regulations (EC) No 1032/2006, (EC) No

633/2007 and (EC) No 262/2009; and

— Commission Implementing Regulation (EU) 2023/177210 of 12 September 2023 amending

Implementing Regulation (EU) No 923/2012 as regards the operating rules related to the use of

5 Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of

the European Air Traffic Management network (the interoperability Regulation) (Official Journal L 096, 31/03/2004 P. 0026) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32004R0552&qid=1697452833323).

6 OJ L 228, 15.9.2023, p. 1. 7 OJ L 228, 15.9.2023, p. 19. 8 OJ L 228, 15.9.2023, p. 39. 9 OJ L 228, 15.9.2023, p. 49. 10 OJ L 228, 15.9.2023, p. 73.

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2. In summary — why and what

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Air Traffic Management and Air Navigation Services systems and constituents in the Single

European Sky airspace and repealing Regulation (EC) No 1033/2006.

The new regulatory framework enables the conformity assessment of ATM/ANS equipment by means

of certification or declaration(s), as well as by the approval of organisations involved in the design or

production of such equipment.

The AMC & GM issued with these Decisions are associated with:

— certification and declaraton aspects laid down in Commission Delegated Regulation (EU)

2023/1768 for the certification and declaration of ATM/ANS equipment; and

— Commission Implementing Regulation (EU) 2023/1769 for the approval of organisations

involved in the design or production of ATM/ANS equipment (DPO approval).

2.2. What we want to achieve — objectives

The overall objectives of the EASA system are defined in Article 1 of the Basic Regulation. The ED

Decisions presented here are expected to contribute to achieving these overall objectives by

addressing the issues described in Section 2.1.

More specifically, with the regulatory material presented here, EASA intends to support the

application of:

— Commission Delegated Regulation (EU) 2023/1768 of 14 July 2023 laying down detailed rules

for the certification and declaration of air traffic management/air navigation services systems

and air traffic management/air navigation services constituents; and

— Commission Implementing Regulation (EU) 2023/1769 of 12 September 2023 laying down

technical requirements and administrative procedures for the approval of organisations

involved in the design or production of air traffic management/air navigation services systems

and constituents.

In this context, the specific objectives of the AMC & GM are to:

— provide a common understanding of the new requirements;

— support the effective and harmonised attestation and conformity assessment and oversight of

ATM/ANS equipment; and

— support the application by all effected/regulated parties,

while promoting and enabling the development and implementation of new technologies and

allocating clear responsibilities to the various actors involved in this activity.

Further details on the objectives of this regulatory framework are explained in Section 2.2 of EASA

Opinion No 01/2023.

2.3. How we want to achieve it — overview of the Decisions

To facilitate the application of the new regulatory framework on ATM/ANS conformity assessment,

this regulatory material encompasses:

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2. In summary — why and what

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— one ED Decision amending ED Decision 2023/016/R to complement the new requirements laid

down in Commission Delegated Regulation (EU) 2023/1768 on the certification and

declaration(s) of ATM/ANS equipment; and

— one new ED Decision associated with Commission Implementing Regulation (EU) 2023/1769 on

technical requirements and administrative procedures for the approval of organisations

involved in the design or production of air traffic management/air navigation services systems

and constituents.

2.3.1. Additional AMC & GM to Commission Delegated Regulation (EU) 2023/1768

Regulation (EU) 2023/1768 establishes the new framework on the conformity assessment of

ATM/ANS equipment taking into account the nature and the risk of the operation or functionality

enabled by the particular ATM/ANS equipment as per point 3 of Annex VIII to the Basic Regulation. It

introduces three different instruments based on the principles established by the Basic Regulation:

— Certification by EASA of ATM/ANS equipment based on DSs (Article 4);

— Declaration of design compliance by an approved DPO, for ATM/ANS equipment based on DSs

(Article 5); and

— SoC by the ATM/ANS provider or by an approved DPO acting on behalf of the ATM/ANS

provider, confirming that the equipment complies with the technical standards listed in DSs

(Article 6).

To support the smooth application of the new regulatory framework, the regulatory material

introduced with ED Decision 2023/016/R addresses:

— an extensive set of AMC & GM associated with Article 6 to address the SoC, the template, the

activities to be performed before the SoC is issued, as well as to address the cases in which a

reissue of the SoC is required, i.e. management of minor and major changes of the ATM/ANS

equipment subject to the SoC; and

— an essential set of AMC & GM relating to the transitional provisions and the set of information

to be provided from the competent authority to the Agency for the purpose of evaluation of

the legacy systems.

On the other hand, this regulatory material introduces:

— GM illustrating the interactions between the regulated parties when the ATM/ANS equipment

is subject to certification, declaration of design compliance or SoC;

— AMC & GM on the novelties introduced with the new framework such as the ATM/ANS

equipment certification basis and the EASA level of involvement.

2.3.2. AMC & GM to Commission Implementing Regulation (EU) 2023/1769

Regulation (EU) 2023/1769 establishes the technical requirements and administrative procedures for

the approval of organisations involved in the design or production of ATM/ANS systems and ATM/ANS

constituents subject to certification in accordance with Article 4 of Delegated Regulation (EU)

2023/1768 or declaration of design compliance in accordance with Article 5 of that Regulation.

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2. In summary — why and what

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To support the smooth application of the new regulatory framework, this regulatory material

addresses the following:

— application for a design and/or production organisation approval and demonstration of

capability;

— failures, malfunctions and defects;

— management system;

— contracted activities; and

— the issue of the release form for the ATM/ANS equipment after being manufactured.

2.4. What are the stakeholders’ views

The comments received via the public consultation of NPA 2023-05 and the workshop held on 4 July

2023 essentially contributed to the improvement of the regulatory material introduced with these ED

Decisions.

Besides the supporting comments, the feedback received addressed specifically topics such as the

classification of minor/major changes of ATM/ANS equipment, activities before the issue of the SoC

and their oversight as well as the transitional measures.

In addition, EASA duly considered the high number of responses to specific questions addressed to

stakeholders in NPA 2023-05, which resulted in the fine tuning of the regulatory material at stake. The

most significant feedback concerns the classification of changes which can be introduced without a

new product assessment.

The comments received and the related EASA responses to them will be presented in Comment-

Response Document (CRD) 2023-05, which will be published after the issue of these ED Decisions and

which will complete the rulemaking activities of RMT.0161 and RMT.0524.

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3. Expected benefits and drawbacks of the regulatory material

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3. Expected benefits and drawbacks of the regulatory material

The regulatory material introduced with these ED Decisions complements the regulatory framework

on the new conformity assessment framework consisting of the five referenced Commission

Delegated and Implementing Regulations (EU) 2023/1768, 2023/1769, 2023/1770, 2023/1771 and

2023/1772.

The main benefits of the regulatory material introduced are that:

— when the regulated parties make use of it, they can demonstrate compliance with the

applicable requirements;

— it increases efficiency in certification and oversight;

— it facilitates harmonisation in the application of the regulatory framework on the conformity

assessment.

No drawbacks are expected.

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4. Monitoring and evaluation

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4. Monitoring and evaluation

EASA will monitor whether the intended objectives will be achieved as part of the monitoring and

evaluation actions described in Chapter 5 of EASA Opinion No 01/2023.

As this regulatory material complements the first set of DSs and AMC & GM to enable the certification

and declaration scheme for certain ATM/ANS equipment that will apply to new and modified (e.g.

upgraded) ATM/ANS equipment designs as well as the approval of DPOs, EASA will monitor its

implementation as follows:

(a) by evaluating feedback from future ATM/ANS equipment certification projects; and

(b) in the long term, by evaluating the trend of the issues encountered with the ATM/ANS

equipment during the investigation of accidents and incidents, as well as other feedback from

ATM/ANS equipment manufacturers, ATM/ANS service providers, and oversight authorities.

Further to monitoring, an evaluation might be performed in the long term but in any case, not earlier

than 5 years from the completion of the transition period stipulated for the new conformity

assessment framework; this evaluation would require the availability of experience gained from

several ATM/ANS equipment certification projects and the issuance of SoCs by ATM/ANS service

providers as well as the oversight of the SoCs by their competent authorities.

Feedback on item (b) above would be available once new and modified (e.g. upgraded) ATM/ANS

equipment designs have entered into service and sufficient experience has been gained with their

operation.

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5. Proposed actions to support implementation

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5. Proposed actions to support implementation

In order to support affected stakeholders in the implementation of the regulatory material included

in the ED Decisions, EASA plans to take the following actions:

— Focused communication for Advisory Body meeting(s) (MAB/SAB/TeB/TEC/COM)

(Advisory Body members)

— Detailed explanation with clarifications on the EASA website

(Primarily targeted audience: industry, competent authorities)

— Dedicated thematic workshops/sessions

(Primarily targeted audience: industry, competent authorities)

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6. References

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6. References

6.1. Related EU regulations

— Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on

common rules in the field of civil aviation and establishing a European Union Aviation Safety

Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010,

(EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and

of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the

European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212,

22.8.2018, p. 1)

— Commission Delegated Regulation (EU) 2023/1768 of 14 July 2023 laying down detailed rules

for the certification and declaration of air traffic management/air navigation services systems

and air traffic management/air navigation services constituents (Commission Delegated

Regulation (EU) 2023/1768 of 14 July 2023 laying down detailed rules for the certification and

declaration of air traffic management/air navigation services systems and air traffic

management/air navigation services constituents (OJ L 228, 15.9.2023, p. 1)

— Commission Implementing Regulation (EU) 2023/1769 of 12 September 2023 laying down

technical requirements and administrative procedures for the approval of organisations

involved in the design or production of air traffic management/air navigation services systems

and constituents and amending Implementing Regulation (EU) 2023/203 (OJ L 228, 15.9.2023,

p. 18)

— Commission Implementing Regulation (EU) 2023/1770 of 12 September 2023 laying down

provisions on aircraft equipment required for the use of the Single European Sky airspace and

operating rules related to the use of the Single European Sky airspace and repealing Regulation

(EC) No 29/2009 and Implementing Regulations (EU) No 1206/2011, (EU) No 1207/2011 and

(EU) No 1079/2012 (OJ L 228, 15.9.2023, p. 39)

— Commission Implementing Regulation (EU) 2023/1771 of 12 September 2023 amending

Implementing Regulation (EU) 2017/373 as regards air traffic management and air navigation

services systems and constituents and repealing Regulations (EC) No 1032/2006, (EC) No

633/2007 and (EC) No 262/2009 (OJ L 228, 15.9.2023, p. 49)

— Commission Implementing Regulation (EU) 2023/1772 of 12 September 2023 amending

Implementing Regulation (EU) No 923/2012 as regards the operating rules related to the use of

Air Traffic Management and Air Navigation Services systems and constituents in the Single

European Sky airspace and repealing Regulation (EC) No 1033/2006

— Commission Implementing Regulation (EU) Commission Implementing Regulation (EU)

2017/373 of 1 March 2017 laying down common requirements for providers of air traffic

management/air navigation services and other air traffic management network functions and

their oversight, repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No

1034/2011, (EU) No 1035/2011 and (EU) 2016/1377 and amending Regulation (EU) No

677/2011 (OJ L 62, 8.3.2017, p. 1)

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6. References

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6.2. Related EASA decisions

— ED Decision 2023/016/R ‘AMC & GM to the Articles of Commission Delegated Regulation (EU)

2023/1768 — Issue 1’

6.3. Other references

— Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004

on the interoperability of the European Air Traffic Management network (the interoperability

Regulation) (OJ L 96, 31.3.2004, p. 26)