ATM/ANS.EQMT.CERT.001 Scope

Regulation (EU) 2023/1768

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

Regulation (EU) 2023/1768

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

Regulation (EU) 2023/1768

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

Regulation (EU) 2023/1768

(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.

GM1 ATM/ANS.EQMT.CERT.015(b)(2) Application for an ATM/ANS equipment certificate

ED Decision 2024/001/R

DEFINITION OF CERTIFICATION PROGRAMME

The certification programme is a document used to establish a protocol of communication between the applicant and EASA in the context of certification of ATM/ANS equipment under Article 4 of Delegated Regulation (EU) 2023/1768, which allows to manage and control the evolving design, as well as the process of compliance demonstration and its verification.

The certification programme may be based on modules/sections that may be updated independently.

GM2 ATM/ANS.EQMT.CERT.015(b)(2) Application for an ATM/ANS equipment certificate

ED Decision 2024/001/R

CONTENT OF THE CERTIFICATION PROGRAMME

The following information is typically included in a certification programme:

Description of the ATM/ANS equipment

An overview of the equipment will be provided, covering, as a minimum, the description of the following:

—             type of system, architecture and functions;

—             performance;

—             dimensions, if applicable;

—             materials, if applicable, and technologies;

—             operational limitations;

—             electronic hardware, and software;

—             additional features, characteristics or functionalities not covered by applicable detailed specifications, as per point ATM/ANS.EQMT.AR.B.001(b);

—             considerations of intended use of the equipment and operating characteristics; and

—             other items, if considered to be more appropriate, that are relevant to the specific ATM/ANS equipment.

A special emphasis on novelties being part of the design (e.g. new technologies, new materials, etc.) and peculiarities of the configuration will be included. The certification programme must be detailed enough, in particular on aspects related to novelty and complexity, to allow EASA to properly estimate its level of involvement as required by point ATM/ANS.EQMT.AR.B.010.

Certification aspects

The following information related to certification will be provided:

—             a proposal for the initial certification basis, in accordance with point ATM/ANS.EQMT.CERT.015(b)(2)(iv), including applicable detailed specifications, reference to special conditions, and reference to equivalent safety findings;

—             a proposal for deviations that are requested at the time of establishing the certification programme, which provide an equivalent level of safety;

—             a proposal for limitations that are expected at the time of establishing the certification programme; and

—             the identification of applicable industry standards, certification memoranda, and guidance material. Where AMC to detailed specifications specifies a certain industry standard(s), and the applicant does not elect to comply with it (them) (partly or completely), the certification programme must identify the request to deviate from the AMC, propose alternative industry standard(s), and demonstrate its (their) equivalence.

For equipment embedding software, the description will identify the main failure conditions that will drive the architecture of the equipment, the classification of the software assurance level (SWAL) to use, and any associated assumption made to define the SWAL.

Equipment configuration

The certification programme must define the equipment model name, part number, and provide the means to configure anticipated minor changes when previously agreed with EASA as part of the DPO change management procedure as required in point DPO.OR.B.005(b) of Implementing Regulation (EU) 2023/1769. 

Demonstration of compliance

The certification programme will include the following, as far as this information is available at the time of submission to EASA:

—             the proposed means of compliance, and the related compliance document(s) as specified in Appendix 1;

—             identification of technical procedures, technical documents and specifications that were followed in the demonstration of compliance;

—             when the compliance demonstration involves testing, a description of the test article(s), test method(s), test location(s), test schedule, test house(s), test conditions, as well as of the intent/objective(s) of the testing; and

—             when the compliance demonstration involves analyses/calculations, a description/identification of the tools (e.g. name and version/release of the software programmes) and methods used, the associated assumptions, limitations and/or conditions, as well as of the intended use and purpose; furthermore, the validation and verification of such tools and methods will be addressed.

For every aspect mentioned above, the applicant will clearly identify whether the demonstration of compliance involves any method (analysis or test) which is novel to or unusual for the applicant.

The applicant will detail the list of documents generated during the development and that will be used to demonstrate compliance with the applicable certification basis.

The applicant will break down the certification programme into one or more meaningful groups of compliance-demonstration activities and data, in accordance with point ATM/ANS.EQMT.CERT.015(b)(2)(v), hereafter referred to as compliance-demonstration items (CDIs), and provide their proposal for EASA’s LoI.

A CDI will be used as a meaningful group of compliance-demonstration activities and data identified in the certification programme which can be considered in isolation for the purpose of performing the certification risk assessment that allows EASA to determine its LoI using a risk-based approach.

The applicant must provide sufficient detailed information about the novelty, complexity, and criticality aspects of the proposed CDI.

Desing organisation and schedule aspects

—             Identification of the relevant personnel who make decisions affecting safety, security and interoperability, and who will interface with EASA, unless otherwise communicated to EASA (e.g. within the DPO procedures);

—             A project schedule including the major milestones;

—             Subcontracting arrangements for design and/or production.

Appendix 1 to GM2 ATM/ANS.EQMT.CERT.015(b)(2) Application for an ATM/ANS equipment certificate

ED Decision 2024/001/R

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

Regulation (EU) 2023/1768

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

Regulation (EU) 2023/1768

(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.

GM1 ATM/ANS.EQMT.CERT.025(e) Demonstration of compliance with the ATM/ANS equipment certification basis

ED Decision 2024/001/R

DECLARATION AT THE END OF COMPLIANCE DEMONSTRATION

Upon completion of all compliance-demonstration activities, the DPO will provide a final declaration indicating that all compliance-demonstration activities have been performed in accordance with the certification programme. This declaration will be provided in the form of a document signed by the DPO accountable manager. The document will typically contain the following:

—             a description of the final equipment configuration;

—             a statement confirming the completion of all compliance-demonstration activities that are performed in accordance with the certification programme as accepted by the Agency;

—             a list of all the applicable life cycle data that supports the demonstration of compliance;

—             a list of the applicable deviations;

—             a list of the applicable limitations;

—             a declaration that:

—             it has demonstrated compliance with the certification basis, as established and notified by the Agency;

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

—             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

Regulation (EU) 2023/1768

(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

Regulation (EU) 2023/1768

(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

Regulation (EU) 2023/1768

(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

Regulation (EU) 2023/1768

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

Regulation (EU) 2023/1768

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

Regulation (EU) 2023/1768

(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

Regulation (EU) 2023/1768

(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

Regulation (EU) 2023/1768

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

Regulation (EU) 2023/1768

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).