The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) met with the European Commission Medical Devices Coordination Group (MDCG) and a number of invited stakeholders on October 20 to discuss the implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
Despite suggestions for postponement from multiple stakeholders including EUCOPE, the MDCG reiterated its commitment to the implementation timeline of 26 May 2021 for the MDR (previously amended from 26 May 2020), and 26 May 2022 for the IVDR.
At the meeting, the Directorate-General for Health and Food Safety (DG SANTE) also updated members on the number of required Notified Bodies for each of the regulations – 17 for MDR and 4 for IVDR. This has long been an area of concern for stakeholders, as there are far fewer Notified Bodies ready for MDR work than had operated under the old system.
MAP graciously thanks EUCOPE sharing this update.