The BVMed – German Medical Technology Association and SNITEM – the French National union of the medical technology industry are launching a Franco-German initiative for Medical Device Regulation. In a joint statement, they call for three important points and an extension of the transition period.
The aim of this initiative is to promote solutions to problems and unclog bottlenecks related to the implementation of the new Medical Device Regulation (MDR). BV-Med and SNITEM jointly demand a rapid expansion of the capabilities of Notified Bodies (NBs) and the reasonable use of available resources through pragmatic handling of existing products.
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The MDR completely redefines the certification of all existing and new medical devices which involves comprehensive challenges for all manufacturers. At least 450,000 different existing products are subject to a new conformity assessment. According to BV-Med and SNITEM, not even 1,000 of the 25,000 required certifications have yet been issued.
BVMed and SNITEM explained in the joined statement: “We are in a backward-looking system that ties up too much 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.” The transition period ends on May 26, 2024, so it has to happen quickly.
The two associations presented the following steps:
- Postponement of the transition period
by two years for higher classified devices (class III and implantable devices) and by four years for all other devices
- Expansion of the capacities of the Notified Bodies
It is essential that NBs continue to massively expand their existing capacities, use them better and, set the priorities correctly. Access to the NBs must be increased and be equally possible for all manufacturers. Triage must be prevented. The designation period for NBs must be shortened, ongoing assessments streamlined and incentives set for further applications.
- Sensible use of existing resources
The associations call for 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 very limited capacities of the NBs for QMS audits and the review of technical documentation. This includes issuing certificates subject to conditions, recognition of all relevant parameters for clinical evaluation with weighting on post-market data and recognition of the principle of similarity, but also the streamlining of consultation processes and the establishment of special regulations for niche products.
Read the joint statement (in German language).
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