© BVMed / MDR implementation
Following the Franco-German initiative of medtech associations BVMed and SNITEM to promote solutions at the European policy level to the challenges of implementing the new EU Medical Devices Regulation (MDR), some 20 other national associations of the European medtech industry have joined the proposed solutions. This was reported by BVMed CEO and board member Dr. Marc-Pierre Möll on the occasion of the European MedTech Forum, which took place in Barcelona from May 3 to 5, 2022.
Among other things, the alliance calls for a rapid expansion of notified body capacities, a sensible use of existing resources through a pragmatic approach to existing products, and an extension of transition periods, as the MDR system is still not operational. The goal of the MedTech associations is for the EU health ministers to address the MDR challenges and their solutions at their next meeting.
"The main problem is the lack of resources at Notified Bodies. The average time for certification is about 18 months. With a transition period until May 2024, this means that by the third quarter of 2022 at the latest, business decisions will have to be made as to which medical devices will have to be withdrawn from the market. That's why we need solutions now," Möll said.
In a letter sent to medtech associations in early April 2022, the German Federal Ministry of Health (BMG) acknowledged that there could be problems implementing the MDR. The BMG urged medical device companies to submit MDR certification applications in a timely manner. However, from BVMed's point of view, the ministry's letter conceals the fact that the notified bodies have no free capacities. Increasingly, applications are even being rejected due to lack of capacity, or existing long-term contracts are being terminated, according to BVMed. Even if all companies were to submit their applications, the implementation of the MDR would encounter enormous difficulties.
"The industry is ready, but the system is not," says BVMed CEO Möll. BVMed cites the following figures in this regard in its #MDReady information campaign, which is currently underway:
- Around 25,000 certificates will be needed by the end of the transition period in May 2024. So far, fewer than 1,000 certificates have been issued under MDR. So in the last five years, less than 5 percent of existing products have been recertified. More than 95 percent will need to be recertified in the next two years.
- According to the Association of Notified Bodies, Team NB, 6,314 certificates can currently be issued per year. Extrapolating, therefore, only about 13,000 certificates could be issued in two years. That is about half the amount needed. If nothing is done, more than 40 percent of the inventory products would disappear from the market. This would exceed BVMed's worst fears.
BVMed, in line with other national medtech associations, is therefore calling for:
- More capacity: Expansion of notified bodies
- More pragmatism: sensible and targeted use of limited resources
- And, as a consequence, more time: postponement of the transition period
