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