© iStock.com/Vadym Terelyuk
Due to the ongoing criticism and at the urging of leading associations such as the German Medical Devices Association (BVMed) and the German Hospital Federation (DKG), the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) is currently looking into possible improvements.
The problems with the implementation of the EU Medical Devices Regulation (MDR) have been extensively discussed at the EPSCO meeting of the health ministries of the European member states on June 14th. BVMed welcomes the fact that EU Commissioner Stella Kyriakides recognised and named the problems in the EPSCO meeting and that a total of 18 member states spoke out in favour of pragmatic solutions.
Kyriakides referred to solutions discussed: Relieve the burden on Notified Bodies; focus on MDR certifications; ease the transition for manufacturers; work with hybrid audits. The Commission would monitor MDR developments and give an update at the next meeting at the end of the year.
But: Waiting is not an option, BVMed states. By the end of the transition period in May 2024, around 24,000 certificates will expire. It is necessary to act quickly and decisively. The Commission has to ensure that sufficient capacities are available on the part of the Notified Bodies.
"The Commission has a responsibility here – and it has to act now, not in December 2022," commented Dr Marc-Pierre Möll, Managing Director and Member of the BVMed Board.
