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BVMed and SNITEM launch German-French initiative on MDR: "We must act now".
Berlin. At a conference in Paris on March 14, 2022, the medtech associations BVMed and SNITEM launched a Franco-German initiative with representatives of the EU Commission to drive forward solutions at the European policy level to the problems encountered in implementing the new EU Medical Devices Regulation (MDR). In a joint declaration, the German Medical Technology Association (BVMed) and the French "Syndicat National de l'Industrie des Technologies Médicales" (SNITEM) call for, among other things, a rapid expansion of the capacities of the notified bodies and a sensible use of existing resources with a pragmatic approach to existing products. The position of the two associations can be downloaded here.
"With BVMed and SNITEM, the two most important national associations in the EU are moving forward together to untangle the MDR implementation bottleneck. This includes, among other things, postponing the MDR transition period. Otherwise, we will not be able to cope with the looming bottleneck of certificates due to the limited resources of Notified Bodies," said SNITEM CEO Eric Le Roy. "The ultimate goal of the efforts must be to continuously ensure the patientcare with safe and modern medical devices. The window of opportunity for solutions is closing, we must act now!" demanded BVMed CEO and board member Dr. Marc-Pierre M ll. He emphasized that Germany and France together account for over 50 percent of the medical device market in the EU. "A strong alliance is forming here that is now leading the way in Europe," M ll said.
The MDR has been in force since May 26, 2021, and completely redefines the certification of all existing and new medical devices. This means that 450,000 different products alone will have to undergo a new conformity assessment. The MDR poses comprehensive challenges for all manufacturers. Small and medium-sized companies in particular are reaching their limits.
According to BVMed and SNITEM, the hope of having a fully functional system in place by the date of application after the one-year postponement of MDR from 2020 to 2021 has not become reality. In fact, the system is only partially operational. Of 25,000 certificates needed, not even 1,000 have been issued so far. There is not only a backlog in the certification of existing products, but also a backlog in innovations, as many development resources are going into MDR regulation.
"We stuck in a backward-looking system that ties up too many of the scarce resources in the industry and at Notified Bodies. With more products to be certified in a shorter period of time and more extensive documentation to be reviewed, the current capacity of the 27 Notified Bodies is insufficient and far from the actual capacity needed. We need to work together on solutions to increase capacity," BVMed and SNITEM said. The window of opportunity is closing. According to the current regulations, the transition period ends on May 26, 2024. "The duration of the certification is on average around 18 months. This means that by the third quarter of 2022 at the latest, business decisions will have to be made as to which products will have to be withdrawn from the market. Time is running out. The situation is coming to a head dramatically. A collapse in patient care must be prevented," says the joint statement from the two associations.
In the view of BVMed and SNITEM, the following steps, among others, are necessary to achieve this:
Strengthening the capacity of Notified Bodies.
For the approximately 25,000 certificates that must be transferred to the MDR, as well as for new products, it is essential that Notified Bodies continue to massively expand their existing capacity, make better use of it and, above all, set the priorities correctly. Access to Notified Bodies must be increased and made equally available to all manufacturers. Triages must be prevented. The designation period for notified bodies must be shortened, ongoing assessments must be streamlined, and incentives must be provided for further applications.
Sensible use of available resources.
The current backward-looking system must change into a forward-looking system. This requires a pragmatic approach to the transfer of existing products to the MDR by creating unbureaucratic opportunities to make the best possible use of the currently limited capacities of the Notified Bodies for QMS audits and the review of technical documentation. This includes the issuance of certificates subject to conditions, recognition of all relevant parameters for clinical evaluation with weighting on postmarket data and recognition of the similarity principle, but also the streamlining of consultation processes and the establishment of special regulations for niche products. In addition, meaningful monitoring of "legacy products" is essential.
Postponement of the transition period.
By extending the transition period in two stages by two years for higher classified products (class III and implantable products) and by four years for all other products, the availability of medical devices with the currently available resources is to be ensured. The end of the sell-off period must also be adjusted accordingly.
"The three points must be implemented hand in hand. Simply extending the transition period is not enough. We need to channel and prioritize existing resources to untangle the MDR bottleneck. We call on the political decision-makers to act now to ensure 3 | BVMed Press Release 18/22 as of 03/14/2022 patient care with safe medical devices in Europe," is the appeal of Dr. Marc-Pierre M ll from BVMed.
Press release of BVMed
March 14 2022
V.i.S.d.P.: Manfred Beeres M.A., Head of Communication/Press, BVMed
Tel.: +49 (0)30 246 2 55-20, beeres@bvmed.de
