Medical device CE marking

2023/2713: Regulation on designating European Union reference laboratories in the field of in vitro diagnostic medical devices


On December 6 Regulation 2023/2713 was published in the Official Journal.

When an EU reference laboratory is designated, according to Regulation (EU) 2017/746, class D devices have to undergo a performance verification and batch testing by the EU reference laboratory. 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.

The document can be downloaded in our library

Source: EUR-Lex