Directive (EU) 2016/797 of the European Parliament and of the CouncilShow full title

Article 15 U.K. Procedure for establishing the ‘EC’ declaration of verification

1. In order to establish the ‘EC’ declaration of verification necessary for placing on the market and placing in service referred to in Chapter V, the applicant shall request the conformity assessment body or bodies that it has selected for that purpose to apply the ‘EC’ verification procedure set out in Annex IV.

2. The applicant shall establish the ‘EC’ declaration of verification of a subsystem. The applicant shall declare on his sole responsibility that the subsystem concerned has been subject to the relevant verification procedures and that it satisfies the requirements of relevant Union law and any relevant national rule. The ‘EC’ declaration of verification and the accompanying documents shall be dated and signed by the applicant.

3. The task of the notified body responsible for the ‘EC’ verification of a subsystem shall begin at the design stage and cover the entire manufacturing period through to the acceptance stage before the subsystem is placed on the market or in service. It shall, in accordance with the relevant TSI, also cover verification of the interfaces of the subsystem in question with the system into which it is incorporated.

4. The applicant shall be responsible for compiling the technical file that is to accompany the ‘EC’ declaration of verification. That technical file shall contain all the necessary documents relating to the characteristics of the subsystem and, where appropriate, all the documents certifying conformity of the interoperability constituents. It shall also contain all the elements relating to the conditions and limits of use and to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance.

5. In the event of the renewal or upgrading of a subsystem resulting in an amendment to the technical file and affecting the validity of the verification procedures already carried out, the applicant shall assess the need for a new ‘EC’ declaration of verification.

6. The notified body may issue intermediate statement verifications to cover certain stages of the verification procedure or certain parts of the subsystem.

7. If the relevant TSIs allow, the notified body may issue certificates of verification for one or more subsystems or certain parts of those subsystems.

8. Member States shall designate the bodies responsible for carrying out the verification procedure in respect of national rules. In that regard, designated bodies shall be responsible for the tasks involved. Without prejudice to Article 30, a Member State may appoint a notified body as a designated body, in which case the entire process may be carried out by a single conformity assessment body.

9. The Commission may specify, by means of implementing acts:

(a) the details of the ‘EC’ verification procedures for subsystems, including the verification procedure in the case of national rules and the documents to be submitted by the applicant for the purposes of that procedure;

(b) the templates for the ‘EC’ declaration of verification, including in the case of a modification of the subsystem or in the case of additional verifications, the intermediate statement of verification, and templates for documents of the technical file that is to accompany those declarations as well as templates for the certificate of verification.

Those implementing acts shall be adopted in accordance with the examination procedure referred to Article 51(3).