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

• CELEX: Delegated Regulation (EU) 2023/1768
• Articles: 11

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  ( 4 ) 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  ( 5 ) ;

(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

1.   The competent authority responsible for issuing certificates for ATM/ANS equipment in accordance with Article 4, for accepting declarations of design compliance of ATM/ANS equipment issued in accordance with Article 5, and for the oversight of certificate and declarations, shall be the Agency. For that purpose, the Agency shall comply with the requirements laid down in Annex I.

2.   The competent authority responsible for the oversight of the statement of compliance issued by an ATM/ANS provider in accordance with Article 6 shall be the same competent authority as the authority responsible for the certification and oversight of that ATM/ANS provider.

Article 4 Certification of ATM/ANS equipment

1.   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.

2.   The certificate referred to in paragraph 1 shall be issued by the Agency.

3.   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.

4.   By way of derogation from paragraph 1, ATM/ANS equipment that is solely being used in a limited part of airspace outside of the ICAO EUR region with low traffic volume, and where that part of the airspace borders only with airspace under the responsibility of a third country, shall not be required to be issued with a certificate. In such a case, the ATM/ANS equipment shall be issued with a statement of compliance in accordance with Article 6.

Article 5 Declaration of design compliance of the ATM/ANS equipment

1.   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.

2.   Declarations of design compliance shall be issued by organisations involved in the design or production of ATM/ANS equipment and which are approved in accordance with Implementing Regulation (EU) 2023/1769.

3.   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.

4.   By way of derogation from paragraph 1, ATM/ANS equipment that is solely being used in a limited part of airspace outside of the ICAO EUR region with low traffic volume, and where that part of the airspace borders only with airspace under the responsibility of a third country, shall not be required to be issued with a declaration of design compliance. In such a case, the ATM/ANS equipment shall be issued with a statement of compliance in accordance with Article 6.

5.   As regards the ATM/ANS equipment of the European Geostationary Navigation Overlay Service (EGNOS) system, the declaration of design compliance as set out in Annex III to this Regulation shall be issued by the European Union Agency for the Space Programme (EUSPA) established by Regulation (EU) 2021/696, which shall be considered as an organisation involved in the design or production of EGNOS equipment.

6.   Points ATM/ANS.EQMT.DEC.005 and ATM/ANS.EQMT.DEC.045 of Annex III shall not be applicable to EUSPA. EUSPA shall ensure that the Agency is given access to evidence from the different entities involved in the design and production of the ATM/ANS equipment of the EGNOS system, in order to determine continued compliance with the applicable technical specifications against which the ATM/ANS equipment declaration was made in accordance with Annex III.

Article 6 Statement of compliance

1.   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.

2.   A statement of compliance for ATM/ANS equipment shall be issued by the ATM/ANS provider that integrates such ATM/ANS equipment in its functional system or, upon request of the ATM/ANS provider, by an organisation involved in the design or production of such ATM/ANS equipment approved in accordance with Implementing Regulation (EU) 2023/1769.

3.   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

1.   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  ( 6 ) 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.

2.   The Agency shall evaluate the ATM/ANS equipment referred to in paragraph 1, points (a) and (b), within 5 years from the date of entry into force of this Regulation and shall publish the results of that evaluation. For that purpose, the competent authorities responsible for the certification and oversight of the ATM/ANS providers referred to in Article 4(1) of Implementing Regulation (EU) 2017/373 shall provide the Agency with the relevant information to facilitate this evaluation. The objective of that evaluation shall be to determine whether the relevant ATM/ANS equipment ensures a level of safety, security, performance and interoperability equivalent to that required by Regulation (EU) 2018/1139 and this Regulation. The result of the evaluation shall be published and any measure to change the ATM/ANS equipment identified by the evaluation shall be applied after 5 years from the date of entry into force of this Regulation, regardless of the actual date when the evaluation takes place, unless the evaluation reveals a deficiency that may have a detrimental effect on safety. In the case a deficiency that may have a detrimental effect is detected, any measure to change the ATM/ANS equipment revealed by the evaluation shall be applied immediately. After 5 years from the date of entry into force of this Regulation, the ATM/ANS equipment referred to in paragraph 1, points (a) to (b), shall be deemed to comply with the requirements of this Regulation.

3.   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.

4.   The Agency shall evaluate the ATM/ANS equipment referred to in paragraph 3 not later than 12 September 2030. For that purpose, the competent authorities responsible for the certification and oversight of the ATM/ANS providers referred to in Article 4(1) of Implementing Regulation (EU) 2017/373 shall provide the Agency with the relevant information to facilitate this evaluation. The objective of that evaluation shall be to determine whether the particular ATM/ANS equipment meets 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 .

Schedules & Appendices

ANNEX I REQUIREMENTS FOR THE AGENCY

ANNEX I

REQUIREMENTS FOR THE AGENCY

(Part-ATM/ANS.EQMT.AR)

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.

(b)

The ATM/ANS equipment certificate shall include the operating limitations, the data sheet for continued suitability, the applicable ATM/ANS equipment certification basis with which the Agency records compliance, and any other conditions or limitations prescribed in the applicable detailed specifications and special conditions.

ATM/ANS.EQMT.AR.B.020 Initial oversight investigation of declaration of design compliance of ATM/ANS equipment

(a)

Upon receiving a declaration of design compliance of the ATM/ANS equipment from an organisation involved in the design or production of ATM/ANS equipment and approved by the Agency in accordance with Implementing Regulation (EU) 2023/1769, the Agency shall verify that the following is complied with:

(1)

the declarant has the privilege to declare design compliance in accordance with point ATM/ANS.EQMT.DEC.005;

(2)

the declaration contains all the information listed in point ATM/ANS.EQMT.DEC.010;

(3)

the declaration does not contain information that indicates a non-compliance with the applicable requirements of Annex III and no feature or characteristic has been identified that may render the ATM/ANS equipment unsafe for the intended use.

(b)

The declaration of design compliance of the ATM/ANS equipment shall include the operating limitations, the data sheet for continued suitability, the applicable detailed specifications with which the organisation has demonstrated compliance, and any other conditions or limitations set out in the applicable detailed specifications and special conditions.

(c)

If the declaration is not consistent with the organisation’s privileges or contains information that indicates non-compliance with the applicable detailed specifications and special conditions, the Agency shall notify the organisation concerned about the non-compliance and request further information, corrective actions, and evidence thereof.

(d)

If the requirements in points (a) and (b) are met, the Agency shall acknowledge the receipt of the declaration.

ATM/ANS.EQMT.AR.B.025 Registration of a declaration of design compliance of ATM/ANS equipment

The Agency shall register a declaration of design compliance of ATM/ANS equipment in a suitable database, provided that:

(a)

the declarant has declared compliance of the ATM/ANS equipment design in accordance with point ATM/ANS.EQMT.DEC.010;

(b)

the declarant has committed to undertake the obligations laid down in Annex III;

(c)

there are no unresolved issues in accordance with point ATM/ANS.EQMT.AR.B.020.

ATM/ANS.EQMT.AR.B.030 Changes to declarations

(a)

Upon receiving a notification of changes in accordance with point ATM/ANS.EQMT.DEC.020, the Agency shall verify the completeness of the notification in accordance with point ATM/ANS.EQMT.AR.B.020.

(b)

When the change(s) affects (affect) any aspect of the declaration that is registered in accordance with point ATM/ANS.EQMT.AR.B.025, the Agency shall update the register.

(c)

Upon completion of the activities required by points (a) and (b), the Agency shall acknowledge receipt of the notification to the organisation involved in the design or production of ATM/ANS equipment.

ANNEX II ATM/ANS EQUIPMENT CERTIFICATES

ANNEX II

ATM/ANS EQUIPMENT CERTIFICATES

(Part-ATM/ANS.EQMT.CERT)

ATM/ANS.EQMT.CERT.001 Scope

This Annex establishes the procedures for the issue of certificates for ATM/ANS equipment in accordance with Article 4, and the rights and obligations of the applicant for, and holder of, those certificates.

ATM/ANS.EQMT.CERT.005 Eligibility

Any natural or legal person who has demonstrated, or is in the process of demonstrating, their design capability in accordance with point ATM/ANS.EQMT.CERT.010, may apply for the issue of an ATM/ANS equipment certificate under the conditions laid down in this Annex.

ATM/ANS.EQMT.CERT.010 Demonstration of capability

An applicant for an ATM/ANS equipment certificate shall hold a design organisation approval issued by the Agency in accordance with Implementing Regulation (EU) 2023/1769 that covers the respective ATM/ANS equipment.

ATM/ANS.EQMT.CERT.015 Application for an ATM/ANS equipment certificate

(a)

An application for an ATM/ANS equipment certificate, or for changes to it, shall be made in a form and manner established by the Agency.

(b)

An application for an ATM/ANS equipment certificate shall include, as a minimum:

(1)

preliminary descriptive data of the ATM/ANS equipment and its intended use;

(2)

a certification programme for the demonstration of compliance in accordance with point ATM/ANS.EQMT.CERT.025, consisting of the following:

(i)

a detailed description of the design, including all the configurations to be certified;

(ii)

the proposed equipment characteristics and limitations;

(iii)

the intended use of the ATM/ANS equipment;

(iv)

a proposal for the initial certification basis, including applicable detailed certification specifications, proposed special conditions, proposed equivalent safety findings, as well as a proposed means of compliance and proposed deviations, as applicable, prepared in accordance with the requirements and options set out in point ATM/ANS.EQMT.AR.B.001;

(v)

a proposal for a breakdown of the certification programme into subjective groups of compliance-demonstration activities and data, including a proposal for the means of compliance and related compliance-demonstration documents;

(vi)

a proposal for the assessment of the subjective groups of compliance-demonstration activities and data, addressing the likelihood of an unidentified non-compliance with the certification-basis requirements and the potential impact of that non-compliance on the ATM/ANS equipment; the proposed assessment shall take into account at least the elements set out in points (a)(2)(i) to (iv) of point ATM/ANS.EQMT.AR.B.010; based on this assessment, the application shall include a proposal for the Agency’s level of involvement in the verification of the compliance-demonstration activities and data;

(vii)

a project schedule including the major milestones.

(c)

Following the initial submission of the application to the Agency, the applicant shall update the certification programme when there are changes to the certification project that affect any of points (b)(2)(i) to (vii).

(d)

An application for the issue of an ATM/ANS equipment certificate shall be valid for 5 years unless the applicant demonstrates at the time of the application that it requires a longer period of time to demonstrate compliance and the Agency agrees to extend that period of time.

(e)

In the case where an ATM/ANS equipment certificate has not been issued, or it is evident that it will not be issued, within the time limit provided for in point (d), the applicant may:

(1)

submit a new application and comply with the requirements for certificationbasis, as established and notified by the Agency in accordance with point ATM/ANS.EQMT.AR.B.001 for the date of submission of the new application; or

(2)

apply for an extension of the time limit provided for in point (d) and propose a new date for the issue of the certificate; in that case, the applicant shall comply with the requirements for certification basis, as established and notified by the Agency in accordance with point ATM/ANS.EQMT.AR.B.001 for a date to be selected by the applicant; however, that date shall not precede the new date proposed by the applicant for the issue of the certificate by more than 5 years for an application for the issue of an ATM/ANS equipment certificate.

ATM/ANS.EQMT.CERT.020 Changes that require the issue of a new ATM/ANS equipment certificate

An approved design organisation that proposes changes to ATM/ANS equipment shall apply for the issue of a new certificate where the changes in the design or the functionality of that ATM/ANS equipment are so extensive that a complete investigation of compliance with the applicable certification basis is required.

ATM/ANS.EQMT.CERT.025 Demonstration of compliance with the ATM/ANS equipment certification basis

(a)

An applicant shall, following the acceptance of the certification programme by the Agency, demonstrate compliance with the ATM/ANS equipment certification basis as established and notified to the applicant by the Agency in accordance with point ATM/ANS.EQMT.AR.B.001, and shall provide the Agency with the means by which such compliance has been demonstrated.

(b)

An applicant for an ATM/ANS equipment certificate shall update the certification programme with the updated certification basis in case the Agency identifies the need for the applicant to do so following the initial submission established in accordance with point ATM/ANS.EQMT.CERT.015.

(c)

An applicant shall report to the Agency any difficulty or event encountered during the process of demonstration of compliance that may have an appreciable effect on the assessment under point ATM/ANS.EQMT.CERT.015(b)(2)(vi) or on the certification programme or may otherwise require a change to the level of involvement of the Agency previously notified to the applicant in accordance with point ATM/ANS.EQMT.AR.B.010(b).

(d)

An applicant shall record demonstrations of compliance within the compliance documents as referred to in the certification programme.

(e)

Upon completion of all compliance-demonstration activities in accordance with the certification programme, including any inspections and tests carried out in accordance with point ATM/ANS.EQMT.CERT.040, an applicant shall declare and submit in a form and manner established by the Agency that:

(1)

it has demonstrated compliance with the certification basis, as established and notified by the Agency, following the certification programme as accepted by the Agency in accordance with point (a);

(2)

no feature or characteristic has been identified that may render the ATM/ANS equipment unsuitable for its intended use.

(f)

The applicant shall demonstrate that the features, characteristics or functions that do not form part of the certification basis have no interference or detrimental effect on the suitability of the ATM/ANS equipment for its intended use.

ATM/ANS.EQMT.CERT.030 Means of compliance

(a)

The Agency shall develop acceptable means of compliance (‘AMC’) that may be used to establish compliance with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.

(b)

Alternative means of compliance may be used to establish compliance with this Regulation.

ATM/ANS.EQMT.CERT.035 ATM/ANS equipment design

(a)

The ATM/ANS equipment design shall consist of:

(1)

the drawings and specifications, and a listing of those drawings and specifications, necessary to define the configuration and the design features shown to comply with the certification basis;

(2)

information on the processes and methods of manufacture and assembly of the equipment necessary to ensure the conformity of the ATM/ANS equipment;

(3)

an approved limitations section of the instructions for continued suitability as defined by the applicable detailed certification specifications;

(4)

any other data that allows by comparison the determination of the suitability of the design.

(b)

Each design shall be adequately identified.

ATM/ANS.EQMT.CERT.040 Inspection and testing

(a)

Before each test is undertaken during the demonstration of compliance required by point ATM/ANS.EQMT.CERT.025, the applicant shall have verified:

(1)

for the test specimen, that:

(i)

the standard parts, elements, configuration, coding and processes conform to the specifications for the proposed design;

(ii)

the developed ATM/ANS equipment conforms to the proposed design;

(iii)

the manufacturing processes, construction and assembly adequately conform to those specified in the proposed equipment design; and

(2)

for the test and the measuring equipment to be used for the test, that those are adequate for the test and appropriately calibrated.

(b)

On the basis of the verifications carried out in accordance with point (a), the applicant shall issue a statement of verification listing any potential non-conformity, together with a justification that this will not affect the test results and shall allow the Agency to perform any inspection it considers necessary to check the validity of that statement.

(c)

The applicant shall allow the Agency to:

(1)

review any data and information related to the demonstration of compliance;

(2)

witness or carry out any test or inspection conducted for the purpose of demonstration of compliance.

(d)

For all the tests and inspections witnessed by the Agency:

(1)

the applicant shall submit to the Agency a statement of verification in accordance with point (b);

(2)

no change that affects the validity of the statement of verification shall be made to the test specimen, or the test and measuring equipment, between the time the statement of verification provided for in point (b) was issued and the time the test specimen is presented to or witnessed by the Agency for testing.

ATM/ANS.EQMT.CERT.045 Record-keeping

In addition to the record-keeping requirements appropriate to or associated with the management system, all relevant design information, drawings and test reports, including inspection records and tests recorded, shall be made available by the certificate holder to the Agency and shall be retained in order to provide the information necessary to ensure the continued compliance.

ATM/ANS.EQMT.CERT.050 Manuals

The holder of an ATM/ANS equipment certificate shall produce, maintain and update master copies of all manuals required by the applicable certification basis, and provide copies, on request, to the Agency.

ATM/ANS.EQMT.CERT.055 Maintenance instructions

(a)

The holder of an ATM/ANS equipment certificate shall furnish at least one set of complete maintenance instructions, comprising descriptive data and accomplishment instructions prepared in accordance with the applicable certification basis, to all known users and shall make them available on request to any other person that is required to comply with any of these maintenance instructions.

(b)

Changes to the maintenance instructions shall be made available to all known users and shall be made available on request to any person that is required to comply with any of these maintenance instructions. A programme that shows how changes to the maintenance instructions are made available to all known users shall be submitted to the Agency.

ATM/ANS.EQMT.CERT.060 Changes to the ATM/ANS equipment certification basis

(a)

All changes shall be approved by the Agency once the certificate holder demonstrates that the changes, and the areas affected by the changes, comply with the certification basis as established by the Agency in accordance with point ATM/ANS.EQMT.AR.B.001.

(b)

By way of derogation from point (a), the changes within the scope of the organisation’s privileges following an approved change management procedure shall be managed by the approved design organisation and shall be limited to specific configuration(s) of the ATM/ANS equipment to which the changes relate.

(c)

For that purpose, the holder of an ATM/ANS equipment certificate shall have a system in place to identify the scope of the changes to ATM/ANS equipment as ‘minor’ and ‘major’.

(d)

The changes shall be issued with a statement in accordance with point (b)(2) of point DPO.OR.C.001 of the Annex II (Part-DPO.OR) to Implementing Regulation (EU) 2023/1769.

ATM/ANS.EQMT.CERT.065 ATM/ANS equipment directives

When an ATM/ANS equipment directive is issued to correct the condition referred to in point (b) of ATM/ANS.EQMT.AR.A.030, the holder of the ATM/ANS equipment certificate, unless otherwise determined by the Agency in case urgent action is needed, shall:

(a)

propose appropriate corrective action and submit details of that proposal to the Agency for approval;

(b)

following the approval by the Agency, make available to all known users of the ATM/ANS equipment and to the competent authorities concerned, and if applicable and on request, to any person required to comply with the ATM/ANS equipment directive, appropriate descriptive data and accomplishment instructions.

ATM/ANS.EQMT.CERT.070 Inspections performed by the Agency

Upon the Agency’s request, each organisation that holds a certificate issued by the Agency under this Annex shall:

(a)

grant the Agency access to any facility, equipment, document, record, data, process, procedure or any other material, and allow the Agency to review any report, make any inspection and perform or witness any test that is necessary to verify the compliance of the organisation with the applicable requirements of this Annex;

(b)

if the natural or legal person employs partners, suppliers or subcontractors, make arrangements with them to ensure that the Agency has access to them and may investigate as described in point (a).

ANNEX III DECLARATION OF DESIGN COMPLIANCE OF THE ATM/ANS EQUIPMENT

ANNEX III

DECLARATION OF DESIGN COMPLIANCE OF THE ATM/ANS EQUIPMENT

(Part-ATM/ANS.EQMT.DEC)

ATM/ANS.EQMT.DEC.001 Scope

This Annex establishes the procedures for declaring compliance of the ATM/ANS equipment design, and establishes the rights and obligations of organisations involved in the design of ATM/ANS equipment that are authorised to issue declarations.

ATM/ANS.EQMT.DEC.005 Eligibility and demonstration of compliance

An organisation involved in the design of ATM/ANS equipment shall demonstrate its capability to declare the compliance of the design of certain ATM/ANS equipment by holding an organisation approval issued by the Agency in accordance with Implementing Regulation (EU) 2023/1769, as specified in the terms of the organisation approval.

ATM/ANS.EQMT.DEC.010 Declaration of design compliance of the ATM/ANS equipment

An approved organisation shall submit to the Agency a dated and signed declaration of compliance of the design of certain ATM/ANS equipment. The declaration shall contain at least the following information:

(a)

description of the design, including all the configurations;

(b)

the rated performance of the equipment, where appropriate, either directly or by reference to other supplementary documents;

(c)

a statement of compliance certifying that the equipment meets the applicable specifications, and a list of the declaration specifications and special conditions, as applicable;

(d)

reference to relevant supporting evidence, including test reports;

(e)

reference to the appropriate operation, set-up and maintenance manuals;

(f)

the levels of compliance, where various levels of compliance are allowed by the declaration specifications;

(g)

list of deviations, as applicable.

ATM/ANS.EQMT.DEC.015 Means of compliance

(a)

The Agency shall develop acceptable means of compliance (‘AMC’) that may be used to establish compliance with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.

(b)

Alternative means of compliance may be used to establish compliance with this Regulation.

ATM/ANS.EQMT.DEC.020 Changes to the declaration of ATM/ANS equipment design

(a)

An approved organisation involved in the design of ATM/ANS equipment may make changes to the design that are within the scope of the approved organisation’s privileges. In this case, the changed equipment shall keep its original part number.

(b)

Any change to the design that is within the scope of the approved organisation’s privileges and that is extensive enough to require a complete investigation in accordance with point ATM/ANS.EQMT.AR.B.020 to determine its compliance shall require the assignment of a new model designation to the equipment.

ATM/ANS.EQMT.DEC.025 Record-keeping

In addition to the record-keeping requirements appropriate to or associated with the management system, all relevant design information, drawings and test reports, including inspection records for the equipment tested, shall be made available to the Agency and shall be retained in order to provide the information necessary to ensure the continued suitability of the ATM/ANS equipment.

ATM/ANS.EQMT.DEC.030 Manuals

The organisation involved in the design of ATM/ANS equipment, which has made the declaration shall produce, maintain and update master copies of all manuals identified in the declaration, and provide copies, on request, to the Agency.

ATM/ANS.EQMT.DEC.035 Maintenance instructions

(a)

The design organisation which has made the declaration shall furnish at least one set of complete maintenance instructions, comprising descriptive data and accomplishment instructions prepared in accordance with the specifications applicable to the ATM/ANS equipment covered by the declaration, to all known users and shall make them available on request to any other person that is required to comply with any of the terms of these maintenance instructions.

(b)

Changes to the maintenance instructions shall be made available to all known users and shall be made available on request to any person that is required to comply with any of these maintenance instructions. A programme that shows how changes to the maintenance instructions are made available to all known users shall be submitted to the Agency upon request.

ATM/ANS.EQMT.DEC.040 ATM/ANS equipment directives

When an ATM/ANS equipment directive is issued to correct the condition referred to in point (b) of ATM/ANS.EQMT.AR.A.030, the declarant of the design compliance of the ATM/ANS equipment shall, unless otherwise determined by the Agency in case urgent action is needed, shall:

(a)

propose appropriate corrective action and submit details of that proposal to the Agency for approval;

(b)

following the approval by the Agency, make available to all known users of the equipment and to the competent authorities concerned, if applicable, and, on request, to any person required to comply with the ATM/ANS equipment directive, appropriate descriptive data and accomplishment instructions.

ATM/ANS.EQMT.DEC.045 Inspections performed by the Agency

Upon the Agency’s request, each organisation that is authorised to issue a declaration in accordance with this Regulation shall:

(a)

grant the Agency access to any facility, equipment, document, record, data, process, procedure or any other material, and allow the Agency to review any report, make any inspection and perform or witness any test that is necessary to verify the compliance and the continued compliance of the organisation with the applicable requirements of this Annex;

(b)

if the natural or legal person uses partners, suppliers or subcontractors, make arrangements with them to ensure that the Agency has access to them and may investigate as provided for in point (a).