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

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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. • MDCG will have subgroups

• Post Market Surveillance & Vigilance (PMSV) • International/IMDRF coordination (INT) • Notified body oversight (NBO) • Market Surveillance (MS) • New technologies (NET) and Software • Clinical investigation and evaluation (CIE) • Annex XVI (no medical purpose products) • In Vitro Diagnostics (IVD) • Unique Device Identification (UDI) • Standards (STAND) • Borderline and Classification (B and C)

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