Commission Implementing Regulation (EU) 2025/2526 of 16 December 2025 amending Implementing Regulation (EU) 2023/2713 to correct the designation of an EU reference laboratory and to designate European Union reference laboratories for in vitro diagnostic medical devices intended for detection or quantification of markers of parasite infection and detection of blood grouping markers

The Annex to Implementing Regulation (EU) 2023/2713 is amended in accordance with the Annex to this Regulation.

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, point 3 of the Annex to this Regulation shall apply from 1 May 2026.

3 Without prejudice to paragraph 2 of this Article, the EU reference laboratories designated in point 3 of the Annex to this Regulation 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 May 2026.