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…
NB Position Papers on Class D devices in absence of EURLs and time to implement guidance documents
Between September and October 2022, Team-NB published various position papers. One of them addresses class D devices and their conformity assessment in absence of EU…
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.…