The European Commission yesterday published Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating the European Union reference laboratories in the field of in vitro diagnostic medical devices
https://eur-lex.europa.eu/legal-con...
With this publication, the European Commission officially designates selected EU reference laboratories in the following areas: hepatitis and retroviruses, herpesviruses, bacterial agents and respiratory viruses. With this official designation, affected Class D devices are expected to undergo performance verification and batch analysis by the EU Reference Laboratory in accordance with Article 100(2). points a) and b), of the IVDR.
The regulation also specifies that designated reference laboratories are expected to form a network aimed at coordinating and harmonizing their working methods in testing and evaluation, which is necessary for the accomplishment of their tasks as defined in Article 100(2) of the IVDR. At the same time, manufacturers and notified bodies must adapt their existing device conformity assessment processes to the new role covered by the EURLs.
In order to allow sufficient time for EURLs, manufacturers and notified bodies to form a network, harmonize and adapt their methods, a transition period is planned. This transition period officially began with the publication of these implementing regulations and will last until October 1, 2024. Thus, class D files filed before October 1, 2024 (products already certified or currently being evaluated by a notified body) will not go through a consultation of the EURLs for performance verification as part of the conformity assessment with a view to CE certification. Only files submitted after October 1, 2024 will be subject to this consultation. Regarding the batch verification activity, this will be applicable from October 1, 2024, and for all class D devices concerned, already certified or in the process of certification.
