On 14 March 2022 the MedTech associations BVMed and SNITEM launched a German-French initiative in Paris with representatives from the EU Commission to promote solutions to problems in the implementation of the new EU Medical Devices Regulation (MDR) at the European policy level at a conference with representatives from the EU Commission.
The German Federal Association of Medical Technology (BVMed) and the French "Syndicat National de l'Industrie des Technologies Médicales" (SNITEM) have issued a joint statement calling for, among other things, a rapid expansion of the capacities of the notified bodies and a prudent use of existing resources through pragmatic handling of existing products.
From the point of view of BVMed and SNITEM, the following steps are necessary, including:
Expansion of the capacities of the notified bodies
- They remark that MDR and notified bodies must continue to expand massively their capacity, make better use of it, and define priorities.
- They emphasize the need to reduce the designation time for notified bodies, expedite continuing reviews, and provide incentives for further applications. Triage must be prevented.
Sensible use of existing resources
- According to BVMed and SNITEM the existing backward-looking system must be transformed to a looking-forward system. This necessitates a realistic approach to the transfer of current items to the MDR by generating unbureaucratic options.
- In their view it is critical to "streamline consultation processes and set particular laws for specialty products."
- Furthermore, relevant, and adequate monitoring of "legacy products" (items still certified under the old rules) is required, according to the associations.
Postponement of the transition period
- The associations agreed that by extending the transition time for medical equipment sold in the EU by two years, and all other devices by four years the availability of medical devices with the currently available resources will be ensured. Additionally, the end of the selling term must likewise beadjusted accordingly.
In the following links you can find more information and press statements: