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

Article 1

Subject matter and scope

This Regulation lays down common technical requirements and administrative procedures for the certification and declaration of design compliance of ATM/ANS systems and ATM/ANS constituents. This Regulation lays down the rules on:

(a) identifying ATM/ANS systems and ATM/ANS constituents which are either subject to certification, declaration, or a statement of compliance;

(b) issuing certificates for ATM/ANS systems and ATM/ANS constituents;

(c) issuing declarations of design compliance of ATM/ANS systems and ATM/ANS constituents by organisations involved in the design or production of ATM/ANS systems and ATM/ANS constituents and which were approved in accordance with Commission Implementing Regulation (EU) 2023/1769 (¹) to have the privileges to issue such declarations of compliance;

(d) issuing statements of compliance of ATM/ANS systems and ATM/ANS constituents by ATM/ANS providers certified in accordance with Implementing Regulation (EU) 2017/373 or by organisations involved in the design or production thereof approved in accordance with Implementing Regulation (EU) 2023/1769;

(e) issuing ATM/ANS equipment directives by the Agency.

Article 2

Definitions

For the purpose of this Regulation, the following definitions apply:

(1) ‘ATM/ANS equipment’ means ATM/ANS constituents as defined by Article 3(6) of Regulation (EU) 2018/1139 and ATM/ANS systems as defined by Article 3(7) of that Regulation, excluding airborne constituents, which are subject to Commission Regulation (EU) No 748/2012 (²);

(2) ‘ATM/ANS equipment directive’ means a document issued by the Agency which mandates actions to be performed by ATM/ANS providers on ATM/ANS equipment to address an unsafe and/or insecure condition that has been identified and restore the performance and interoperability of that ATM/ANS equipment when evidence shows that the safety, security, performance or interoperability of that particular equipment may otherwise be compromised;

(3) ‘European air traffic management network’ (EATMN) means the collection of systems, listed in point 3.1 of Annex VIII to Regulation (EU) 2018/1139, enabling air navigation services in the Union to be provided, including the interfaces at boundaries with third countries;

(4) ‘functional system’ means a combination of procedures, human resources and equipment, including hardware and software, organised to perform a function within the context of ATM/ANS and other ATM network functions.

Article 3

Competent authority

Article 4

Certification of ATM/ANS equipment

The following ATM/ANS equipment shall be issued with a certificate as set out in Annex II:

(a) equipment supporting controller–pilot communications;

(b) equipment supporting air traffic control (ATC) services when enabling the separation of aircraft or the prevention of collisions.

The certificate referred to in paragraph 1 shall be issued for an unlimited duration. It shall remain valid indefinitely except where:

(a) the certificate holder no longer complies with the requirements of this Regulation; or

(b) as regards ATM/ANS equipment, there is no valid organisation approval issued by the Agency in accordance with Implementing Regulation (EU) 2023/1769; or

(c) the ATM/ANS equipment no longer complies with its certification basis in accordance with point ATM/ANS.EQMT.CERT.025 of Annex II; or

(d) the certificate has been surrendered by its holder or revoked by the Agency.

Upon surrender or revocation of the certificate, if issued in a paper format, it shall be returned to the Agency without delay.

Article 5

Declaration of design compliance of the ATM/ANS equipment

The following ATM/ANS equipment when it generates, receives, and transmits data and/or signals in space for the purpose of ensuring safe and interoperable air navigation shall be issued with a declaration of design compliance as set out in Annex III:

(a) equipment supporting ground-to-ground communications;

(b) equipment supporting navigation or surveillance.

Declarations of design compliance of the ATM/ANS equipment shall be issued for an unlimited duration. Declarations shall remain valid unless they have been deregistered in accordance with point DPO.AR.C.015(g)(6) of Annex I to Implementing Regulation (EU) 2023/1769 as a result of one of the following:

(a) the ATM/ANS equipment no longer complies with the detailed specifications which enabled the declaration to be issued;

(b) the issuer of the declaration no longer complies with the applicable requirements of Implementing Regulation (EU) 2023/1769 or its approval has been surrendered, suspended or revoked;

(c) the ATM/ANS equipment has proved to give rise to unacceptable risk or unacceptable performance in service;

(d) the organisation has withdrawn the declaration of design compliance.

Article 6

Statement of compliance

The following ATM/ANS equipment shall be issued with a statement of compliance:

(a) equipment that is neither subject to certification in accordance with Article 4 nor to a declaration of compliance in accordance with Article 5; and

(b) it supports air traffic services, communication, navigation or surveillance services, airspace management, air traffic flow management, aeronautical information services or meteorological services.

The statement of compliance shall confirm that the ATM/ANS equipment complies with the detailed specifications issued by the Agency in accordance with Article 76(3) of Regulation (EU) 2018/1139.

A statement of compliance for ATM/ANS equipment shall be issued for an unlimited duration. It shall remain valid unless any of the following applies:

(a) the ATM/ANS equipment no longer complies with the essential requirements set out in Annex VIII and, if applicable, in Annex VII to Regulation (EU) 2018/1139;

(b) the ATM/ANS provider no longer complies with the applicable requirements of Implementing Regulation (EU) 2017/373 or it has surrendered the certificate issued in accordance with Article 6 of Implementing Regulation (EU) 2017/373, or the certificate has been suspended or revoked;

(c) the ATM/ANS provider has withdrawn the statement of compliance or enforcement measures have been taken in accordance with point ATM/ANS.AR.C.050(e) of Annex II to Implementing Regulation (EU) 2017/373.

Article 7

Transitional provisions

The following transitional provisions shall apply to ATM/ANS equipment holding EC declarations issued in accordance with Articles 5 or 6 of Regulation (EC) No 552/2004 of the European Parliament and of the Council (³) and that has been put into operation before the date of entry into force of this Regulation:

(a) ATM/ANS equipment which falls within the category of ATM/ANS equipment that requires certification in accordance with Article 4 shall be deemed to have been issued with a certificate in accordance with Article 4 unless the Agency determines, following the evaluation referred to in paragraph 2, that such ATM/ANS equipment does not ensure a level of safety, security, performance and interoperability equivalent to that required by Regulation (EU) 2018/1139 and this Regulation;

(b) ATM/ANS equipment which falls within the category of ATM/ANS equipment that is required to be declared in accordance with Article 5 shall be deemed to have been issued with a declaration of design compliance in accordance with Article 5 unless the Agency determines, following the evaluation referred to in paragraph 2, that such ATM/ANS equipment does not ensure a level of safety, security, performance and interoperability equivalent to that required by Regulation (EU) 2018/1139 and this Regulation;

(c) as regards ATM/ANS equipment which is subject to a statement of compliance in accordance with Article 6, the EC declarations of verification of systems that have been issued or recognised in accordance with Article 6 of Regulation (EC) No 552/2004 shall continue to be valid for an unlimited duration and shall be deemed to have a statement of compliance pursuant to Article 6.

ATM/ANS equipment that is subject to certification in accordance with Article 4 or a declaration in accordance with Article 5 may be put into operation from the date of entry into force of this Regulation until 12 September 2028 on the basis of a statement of compliance made in accordance with Article 6. As from 13 September 2028, the following provisions shall apply to such ATM/ANS equipment:

(a) ATM/ANS equipment which falls within the category of ATM/ANS equipment that requires certification in accordance with Article 4 and for which a statement of compliance was issued by the ATM/ANS provider shall be deemed to have been issued with a certificate in accordance with Article 4 unless the Agency determines, following the evaluation referred to in paragraph 4, that such ATM/ANS equipment does not ensure a level of safety, security, performance and interoperability equivalent to that required by Regulation (EU) 2018/1139 and this Regulation;

(b) ATM/ANS equipment which falls within the category of ATM/ANS equipment that requires a declaration of design compliance in accordance with Article 5 and for which a statement of compliance was issued by the ATM/ANS provider shall be deemed to have been issued with a declaration of design compliance in accordance with Article 5 unless the Agency determines, following the evaluation referred to in paragraph 4 that such ATM/ANS equipment does not ensure a level of safety, security, performance and interoperability equivalent to that required by Regulation (EU) 2018/1139 and this Regulation.

Article 8

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

SUBPART A

GENERAL REQUIREMENTS (ATM/ANS.EQMT.AR.A)

ATM/ANS.EQMT.AR.A.001 Scope

This Annex establishes the requirements for the Agency concerning the conditions for conducting certification and other necessary activities to ensure effective oversight of ATM/ANS equipment and the conditions and procedures for the accreditation of qualified entities by the Agency.

ATM/ANS.EQMT.AR.A.020 Allocation of tasks to qualified entities

(a) When the Agency decides to allocate tasks related to the certification of ATM/ANS equipment subject to this Regulation, the approval or the continuing oversight of organisations subject to Implementing Regulation (EU) 2023/1769 to qualified entities, it shall ensure that it has established and documented an agreement with the qualified entity(ies), approved by both parties to that agreement at the appropriate management level, which clearly defines: (1) the tasks to be performed; (2) the declarations, reports and records to be provided; (3) the technical conditions to be met when performing the tasks; (4) the related liability coverage; (5) the protection given to information acquired when carrying out the tasks.

(b) The Agency shall ensure that the internal audit process and the safety risk management process required by point DPO.AR.B.001 (a)(5) of Implementing Regulation (EU) 2023/1769 cover all the tasks performed on its behalf by the qualified entity(ies).

(c) With regard to the approval and oversight of the organisation’s compliance with point DPO.OR.B.001 (d) of Implementing Regulation (EU) 2023/1769, the Agency may allocate tasks to qualified entities in accordance with point (a), or to any relevant authority responsible for information security or cybersecurity within the Union. When allocating tasks, the Agency shall ensure that: (1) all aspects related to aviation safety are coordinated and taken into account by the qualified entity or relevant authority; (2) the results of the approval and oversight activities performed by the qualified entity or relevant authority are integrated in the overall certification and oversight files of the organisation; (3) its own information security management system established in accordance with point DPO.AR.B.001 (d) of Implementing Regulation (EU) 2023/1769 covers all the certification and continuing oversight tasks performed on its behalf.

ATM/ANS.EQMT.AR.A.030 ATM/ANS equipment directives

(a) The Agency shall issue an ATM/ANS equipment directive when: (1) an unsafe, insecure, underperformance or non-interoperability condition has been determined by the Agency to exist in the equipment as a result of a deficiency in the equipment; and (2) that condition is likely to exist or develop in other ATM/ANS equipment.

(b) An ATM/ANS equipment directive shall contain at least the following information: (1) identification of the unsafe, insecure, underperformance or non-interoperability condition; (2) the affected ATM/ANS equipment; (3) the required action(s) and the rationale; (4) the accomplishment time for the required action(s); (5) the date of entry into force.

ATM/ANS.EQMT.AR.A.035 Detailed specifications for the equipment design compliance

(a) The Agency shall establish and make available detailed specifications which organisations may use to demonstrate compliance with the relevant essential requirements set out in Annex VIII and, if applicable, Annex VII to Regulation (EU) 2018/1139 when they: (1) apply for the certification of ATM/ANS equipment in accordance with Article 4; (2) declare design compliance of ATM/ANS equipment in accordance with Article 5; (3) make a statement of compliance in accordance with Article 6.

(b) The detailed specifications referred to in point (a) shall indicate design standards which reflect the state of the art and best design practices, and which build on valuable experience gained and scientific and technical progress, and on the best available evidence and analyses as regards ATM/ANS equipment.

SUBPART B

CERTIFICATION, OVERSIGHT, AND ENFORCEMENT (ATM/ANS.EQMT.AR.B)

ATM/ANS.EQMT.AR.B.001 ATM/ANS equipment certification basis

(a) The Agency shall establish the ATM/ANS equipment certification basis and notify it to the applicant for an ATM/ANS equipment certificate. The certification basis shall consist of the following: (1) detailed certification specifications issued by the Agency in accordance with point ATM/ANS.EQMT.AR.A.035 that are applicable to the ATM/ANS equipment on the date of submission of the application for that certificate, unless: (i) the applicant chooses to comply, or is required to comply in accordance with point ATM/ANS.EQMT.CERT.015(e), with detailed certification specifications that became applicable after the date of the submission of the application, in which case the Agency shall include in the ATM/ANS equipment certification basis any other certification specifications that are directly related; or (ii) the Agency accepts any alternative to a determined detailed certification specification that cannot be complied with, for which compensating factors have been found that provide an equivalent level of safety or to ensure equivalence with the applicable certification specifications; and (2) any special conditions prescribed by the Agency in accordance with point ATM/ANS.EQMT.AR.B.005.

(b) The possible inclusion of additional features, characteristics or functions not initially included in the certification basis shall be agreed by the Agency.

ATM/ANS.EQMT.AR.B.005 Special conditions

(a) The Agency shall establish additional requirements, named ‘special conditions’, for ATM/ANS equipment if the related applicable detailed specifications are not deemed adequate because of one of the following: (1) the ATM/ANS equipment has novel or unusual design features relative to the design practices on which the applicable detailed specifications are based; (2) the intended use of the ATM/ANS equipment is unconventional; (3) experience with other similar ATM/ANS equipment in service having similar design features or newly identified risks has shown that unwanted conditions may develop; (4) the environment at the location of installation physically prevents the fulfilment of certain requirements of the applicable detailed specifications.

(b) Special conditions contain safety, performance, security, and interoperability standards that the Agency finds necessary to ensure that the appropriate level of performance of the ATM/ANS equipment is equivalent to that required by the applicable detailed specifications.

ATM/ANS.EQMT.AR.B.010 Level of involvement

(a) The Agency shall determine its level of involvement in the verification of compliance-demonstration activities and data related to an application for the issue of a certificate or for changes to it. It shall determine this based on the assessment of subjective groups of compliance-demonstration activities and data from the certification programme. The assessment shall address all of the following: (1) the likelihood of an unidentified non-compliance with the certification basis; (2) the potential impact of that non-compliance on safety, security, service specifications and functioning of the ATM/ANS equipment. It shall consider at least the following elements: (i) novel or unusual features of the certification project, including operational, organisational and knowledge-management aspects; (ii) complexity of the design and/or the demonstration of compliance; (iii) criticality of the design or the technology, the related safety, security or service-compliance risks and the functioning of the ATM/ANS equipment, including those identified on similar designs; (iv) performance and experience of the applicant in the domain concerned.

(b) The Agency shall notify its level of involvement to the applicant and shall update its level of involvement when this is warranted by information which has an appreciable impact on the risk previously assessed in accordance with point (a). The Agency shall notify the applicant about any change to the level of involvement.

ATM/ANS.EQMT.AR.B.015 Issue of an ATM/ANS equipment certificate

(a) The Agency shall issue a certificate for ATM/ANS equipment, provided the following: (1) the applicant has demonstrated compliance with point ATM/ANS.EQMT.CERT.015; (2) the Agency has not identified any non-compliance with the ATM/ANS equipment certification basis through the verification of the compliance-demonstration activities determined in accordance with point ATM/ANS.EQMT.AR.B.010; (3) no feature or characteristic has been identified that may render the equipment unsafe for the intended use.