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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 December 2023.

For the Commission

The President

Ursula VON DER LEYEN

( 1 ) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ( OJ L 117, 5.5.2017, p. 176 ).

( 2 ) Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices ( OJ L 164, 20.6.2022, p. 7 ).

COMMISSION IMPLEMENTING REGULATION (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of ANNEX EU reference laboratories designated in accordance with Article 1