In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses the application of transitional provisions for certification of class D…
Call for EU reference laboratories to Member States
In July 2022, the European Commission opened its call for Member States to submit applications for EU reference laboratories. The call is for EU Member…
European Reference Laboratories: criteria, tasks, and fees
The new Regulation on in vitro diagnostic medical devices brought many changes in the IVD sector. In line with stricter assessment procedures, the Regulation introduced…
IVDR: Verification of class D IVDs by notified bodies
The Medical Device Coordination Group (MDCG) has published a Guidance establishing the activities of notified bodies in the verification process of class D IVD devices.…