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:

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).

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:

The Agency shall issue an ATM/ANS equipment directive when:

An ATM/ANS equipment directive shall contain at least the following information:

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:

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.

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:

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

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:

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.

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:

It shall consider at least the following elements:

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.

The Agency shall issue a certificate for ATM/ANS equipment, provided the following:

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.

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:

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.

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.

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

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

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

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

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.

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.

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.

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.

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

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).

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.

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:

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.

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.

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).

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

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:

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.

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.

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

The ATM/ANS equipment design shall consist of:

Each design shall be adequately identified.

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

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.

The applicant shall allow the Agency to:

For all the tests and inspections witnessed by the Agency:

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.

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.

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.

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.

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’.

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.

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

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.

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;

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).

description of the design, including all the configurations;

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

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

reference to relevant supporting evidence, including test reports;

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

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

list of deviations, as applicable.

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.

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

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.

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.

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.

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.

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

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.

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;

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).