Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices

The laboratories listed in the Annex are designated as EU reference laboratories for the specific devices or a category or group of devices, or for specific hazards related to a category or group of devices, as specified in that Annex.

1 This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

2 For the purpose of the tasks referred to in Article 100(2) of Regulation (EU) 2017/746, this Regulation shall apply from 1 October 2024.

3 Without prejudice to paragraph 2 of this Article, EU reference laboratories shall carry out the task referred to in Article 100(2), point (a), of Regulation (EU) 2017/746, only for devices for which manufacturers or authorised representatives lodge formal applications for conformity assessment with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII to Regulation (EU) 2017/746 from 1 October 2024.