At the EPSCO Health Council on 14 June 2022, Health Ministers expressed their concerns that severe challenges related to the implementation of Regulation (EU) 2017/745 on medical devices (MDR) threaten the continued availability of certain medical devices needed for health systems and patients and may jeopardize the access of innovative medical devices to the EU market.
Health Ministers called on the Medical Device Coordination Group (MDCG) to propose solutions to address, as a matter of urgency, immediate challenges related to the insufficient capacity of notified bodies to certify medical devices in accordance with the MDR within the remaining transition period that ends on 26 May 2024 and the level of preparedness of manufacturers.
The Commission committed to report back to the EPSCO Council on 9 December 2022 and to present further proposals for solutions if needed.