Franco-German initiative launched

    (06/2022) In a joint declaration, the German Medical Technology Association (BVMed) and the French "Syndicat National de l'Industrie des Technologies Médicales" (SNITEM) call for a rapid expansion of the capacities of the notified bodies and a sensible use of the existing resources a pragmatic approach to existing products.

    According to BVMed and SNITEM, the hope of having a fully functional system by the time the MDR came into force after the one-year postponement of the start of application of the MDR from 2020 to 2021 has not become reality. In fact, the system is only partially operational. Of the 25,000 required certificates, not even 1,000 have been issued so far. Both associations unanimously criticize that there is not only a backlog in the certification of existing products, innovations are also stagnating, since many development resources go into the MDR regulations.

    Enormous pressure to act

    Above all, the bottleneck of the MDR implementation must now be equalized. “This includes, among other things, the postponement of the transition period of the MDR. Otherwise we will not be able to cope with the impending bottleneck in the certificates due to the limited resources of the notified bodies," says SNITEM Managing Director Eric Le Roy. “The primary goal of the efforts must be to continuously guarantee the medical care of people with safe and modern medical products. The time window for solutions is closing, we have to act now," adds BVMed Managing Director and board member Dr. Marc Pierre Moell.

    He emphasizes that Germany and France together account for over 50 percent of the medical device market in the EU. "A strong alliance is emerging here that is now making progress in Europe," says Möll.

    Time is running out

    The joint statement from the two associations states: “We find ourselves in a backward-looking system that ties up too many of the scarce resources in industry and Notified Bodies. With more products to be certified in a shorter period of time and more extensive documents to be checked, the current capacity of the currently 27 notified bodies is not sufficient and is far from the capacity actually required. We have to work together on solutions to increase capacities.”

    And that has to happen quickly, because according to the previous regulations, the transition period ends on May 26, 2024. The average duration of the certification is around 18 months. This means that by the third quarter of 2022 at the latest, the business decisions would have to be made as to which products would have to be taken off the market. Time is running out for everyone, the situation is coming to a head dramatically. A collapse in patient care must be prevented.

    The core requirements
    • Expansion of the capacities of the notified bodies. With a view to the approximately 25,000 certificates that have to be transferred to the MDR, as well as new products, notified bodies must further expand their existing capacity, use it better and set the right priorities. Access to the notified bodies must be increased and be equally possible for all manufacturers. Triage must be prevented. The designation period for notified bodies must be shortened, ongoing assessments must be streamlined and incentives for further applications must be set.
    • Pragmatic handling of the transfer of existing products to the MDR by creating unbureaucratic opportunities to use the limited capacities of the notified bodies for QMS audits and the review of technical documentation in the best possible way. This includes the issuance of conditional certificates, the recognition of all relevant parameters for clinical evaluation with weighting on post-market data and the recognition of the principle of similarity, but also the streamlining of consultation processes and the establishment of special regulations for niche products. Sensible and appropriate monitoring of "legacy products" (products that were still certified under the old guidelines).
    • Postponement of the transition period. Two-stage extension of the transition period by two years for higher classified devices (Class III and implantable devices) and by four years for all other devices to ensure the availability of medical devices with currently available resources; at the same time, the corresponding adjustment of the sell-off period.

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