Implementation of the Medical Device Regulation (MDR)
Publication Date: Jan 3rd, 2023 10:15, Category: EFOMP Announcements
To EFOMP National Member Organisations
Please find enclosed a letter from the Council of the EU with respect to the implementation of the Medical Device Regulation. The Commission has listened to the concerns expressed by the Member states and it considered an extension of the translational period depending on the risk class of devices. 'Those deadlines could be 2027 for class III and class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e. lower risk devices) that need the involvement of a notified body in the conformity assessment'.
During the EFOMP Annual Council Meeting in October 2019, in Warsaw, Poland, the Dutch NMO informed the EFOMP Council about the implications of the new MDR (presentation attached), and was decided to regularly update the Council about any further actions on this matter.
A special session was organised during the EFOMP congress in Dublin, Ireland in August 2022.