Commission Implementing Regulation 2023/2713 on the designation of European Union reference laboratories in the field of in vitro diagnostic medical devices published
12 December 2023
On December 6, the European Commission published the Implementing Regulation (EU) 2023/2713 designating European Union reference laboratories (hereinafter EU reference laboratories) in the field of in vitro diagnostic medical devices.
Enforced on 9 December 2023, the implementing regulation applies from 1 October 2024 onwards. It designates EU reference laboratories of the European Union for the specific devices or a category or group of devices, or for specific hazards related to a category or group of devices. With respect to testing and assessment, the working methods in the EU reference laboratories are harmonised in accordance with Article 100(5) of Regulation (EU) 2017/746. Article 100(2) defines the tasks of the EU reference laboratories which include advisory services as well as tasks related to conformity assessment, with a special focus on class D devices. The designation criteria are specified in Article 100 (4).
The EU reference laboratories are listed by name in the Annex of Implementing Regulation (EU) 2023/2713 in accordance with Article 1 and comprise the following product categories: devices intended for detection or quantification of markers of hepatitis or retrovirus infection, herpesvirus infection, infection with bacterial agents and respiratory virus infection.