Commission Implementing Regulation (EU) 2018/763Show full title

Article 11 U.K. Coordination between the Agency and national safety authorities

1. When acting as the certification body, the Agency shall coordinate with the national safety authorities concerned with the intended area of operation at the different stages of the safety assessment process. The Agency and the national safety authorities shall discuss any issues relating to the safety assessment process, including any deficiency, and any requests for supplementary information which have an impact on the timeframe of the assessment or have the potential to affect the work of the other national safety authorities concerned with the area of operation.

2. Without prejudice to paragraph 1, each body involved in the safety assessment process may take direct contact with the applicant with regard to issues related to its own part of the assessment.

3. Before deciding on the issuing of a single safety certificate, the Agency and the national safety authorities concerned with the intended area of operation shall take the following steps:

(a) discuss the outcome of their respective assessments;

(b) agree on any residual concerns to be deferred for consideration during later supervision;

(c) agree on any restrictions or conditions of use to be included in the single safety certificate.

4. Where the applicant establishes an action plan to address the residual concerns referred to in point (b) of paragraph 3, the national safety authorities shall agree which of them shall follow up its completion. To that end, the national safety authorities shall coordinate where appropriate, in accordance with the arrangements referred to in Article 8(2) of Delegated Regulation (EU) 2018/761(1), and inform the Agency about their agreement and the outcome of their related supervision activities.

The Agency shall take into account information on the outcome of supervision activities carried out by the national safety authorities concerned with the intended area of operation regarding the follow up of residual concerns to decide whether these can be closed during the assessment of the update or renewal application.

5. The Agency shall keep records of coordination activities and shall register them in the one-stop shop in accordance with Article 9.

(1)

Commission Delegated Regulation (EU) 2018/761 of 16 February 2018 establishing common safety methods for supervision by national safety authorities after the issue of a single safety certificate or a safety authorisation pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 1077/2012 (see page 16 of this Official Journal).