The Official Journal of the European Union has published Implementing Regulation (EU) 2023/2713 designating European Union Reference Laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs). It applies from 1 October 2024.
The laboratories have been designated for performance evaluation and batch testing of the following device categories:
- Devices intended for the detection or quantification of markers of hepatitis viruses or retroviruses infection
- Devices intended for detection or quantification of herpesvirus infection markers
- Devices intended for detection or quantification of markers of infection with bacterial agent
- Devices intended for detection or quantification of markers of respiratory virus infection
The list of reference laboratories is given in the annex to the Implementing Regulation.
Class D devices belonging to these categories and for which a formal application for certification under Regulation (EU) 2017/746 has been lodged before October 1, 2024, are exempt from performance assessment by the EURL, as part of the initial conformity assessment procedure. However, batch testing will apply to all Class D devices from October 1, 2024.