Mar 25, 2020

The European Union’s Medical Device Coordination Group (MDCG) published three new guidance documents and revised existing ones. Much of this new material addresses issues resulting from the transition from the Medical Devices Directive (MDD) and In Vitro Diagnostic Devices Directive (IVDD) to the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read on for an overview of the new publications and revisions.

First new MDCG guidance documents of 2020

Revisions to existing guidances, including expanded UDI-DI change criteria

Related European MDR resources available from Emergo by UL: