BAKGRUNN (fra kommisjonsforordningen)

(1) In accordance with Article 100(1) of Regulation (EU) 2017/746, in July 2022 the Commission launched a call for applications for EU reference laboratories in eight scopes of designation as referred to in Article 1(1) of Commission Implementing Regulation (EU) 2022/944 (2).

(2) In response to the call of July 2022, applications for designation were submitted by Member States by 31 March 2023 and evaluated by a selection board set up by the Commission services.

(3) The selection board took into account the criteria for EU reference laboratories laid down in Article 100(4) of Regulation (EU) 2017/746 as well as Articles 1 to 9 of Implementing Regulation (EU) 2022/944.

(4) When an EU reference laboratory is designated, according to Article 48(5) of Regulation (EU) 2017/746, and Sections 4.11 and 4.12 of Annex IX, as well as Section 5.4 of Annex X, and Section 5.1 of Annex XI, to Regulation (EU) 2017/746, class D devices have to undergo performance verification and batch testing by the EU reference laboratory in accordance with Article 100(2), points (a) and (b), respectively, of that Regulation. Therefore, to ensure sufficient availability of EU reference laboratory services, the selection board also took into account the collective capacity of the candidate laboratories for performance verification and batch testing.

(5) Following the completion of the selection procedure, the successful laboratories should be designated as the EU reference laboratories, specifying their scope of designation.

(6) Article 100(5) of Regulation (EU) 2017/746 provides that the EU reference laboratories are to form a network in order to coordinate and harmonise their working methods as regards testing and assessment, which is necessary for performing the tasks set out in Article 100(2) of that Regulation. Moreover, manufacturers and notified bodies need to adapt their existing processes for conformity assessment of devices as a consequence of the designation of EU reference laboratories and their involvement in conformity assessment. To allow the newly designated EU reference laboratories sufficient time to form a network and coordinate and harmonise their working methods, and manufacturers and notified bodies to adapt their processes, the application of the designation of the EU reference laboratories for the purposes of the tasks referred to in Article 100(2) of Regulation (EU) 2017/746 should be deferred until a later date.

(7) To ensure legal certainty and predictability of conformity assessment procedures, the newly designated EU reference laboratories should only perform the task set out in Article 100(2), point (a), of Regulation (EU) 2017/746 in respect of devices for which the formal application for conformity assessment is lodged after the designation of the EU reference laboratories applies for the purpose of the tasks set out in Article 100(2) of that Regulation,