Essentials of European Medical Device Regulatory Affairs

EU Commission - now

Committee on medical devices • Regulatory power to change classification rules

• Implementation of Eudamed • Measures are legally binding

– E.g. Hip replacement reclassification

• Only meets when necessary • Medical device expert group (MDEG) • Other working groups

The Organisationfor Professionals inRegulatory Affairs

EU Commission - future • An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States (MS) based on their role and expertise in the field of medical devices including in vitro diagnostic medical devices (meeting quarterly in 2019) • To provide advice to the Commission aiming for a harmonised implementation of the Regulation.

The Organisationfor Professionals inRegulatory Affairs