On December 5th, 2023, the EU Commission adopted implementing regulation (EU) 2023/2713 designating 5 European Union reference laboratories in the field of in vitro diagnostic medical devices. These 5 European Union reference laboratories will be involved in the conformity assessment of Class D in vitro diagnostic devices and other advisory tasks. The important tasks these laboratories have been designated for are outlined in Article 100(2) of regulation (EU) 2017/746.
The categories of Class D devices that will be covered by the reference labs are the following;
- Hepatitis or retrovirus infection.
- Herpesvirus infection.
- Infection with bacterial agents.
- Respiratory virus infection.
Please note there is a transition period in place until October 1st, 2024. Laboratories will start testing after this date.
For a copy of the implementing regulation, please click here.
For a copy of regulation (EU) 2017/746, please click here.
