Regulation (EU) 2023/1768
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
Regulation (EU) 2023/1768
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
Regulation (EU) 2023/1768
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
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.DEC.020 Changes to the declaration of ATM/ANS equipment design
Regulation (EU) 2023/1768
(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
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 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.
Regulation (EU) 2023/1768
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
Regulation (EU) 2023/1768
(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
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 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
Regulation (EU) 2023/1768
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).