Appeal for a rapid European solution
The application of the MDR is mandatory as of May 26, 2021. The issue still poses challenges for companies and many still need clarification on how the requirements can be implemented without harming their business. This is nicely illustrated by the fact that EFLCIN offers yet another workshop on the topic of MDR preparation at their 2022 congress. At a recent panel, it was expressed how severe the consequences of MDR could be, not only for the companies involved, but also for the patients, in the worst case scenario.
“Brussels – we have a problem!” Corinna Mutter, Regulatory Affairs Manager at the German industry association Spectaris, summed up the event with these urgent words. Organized by the Baden-Württemberg Ministry of Health and Economics, the Brüsseler Gespräche (Brussels talks) gathered voices from the medical device industry, EU and state policy makers, and industry associations. The search for the best solutions to overcome the implementation difficulties of the MDR was thus given new impetus and at the same time concrete recommendations for action were contributed.
In the course of the debate, industry and state politicians appealed to the EU Commission for a rapid European solution, because as Mutter emphasized, we are only seeing the tip of the iceberg of product discontinuations due to the MDR. However, these are already having a tangible impact on patient care. The question is how the worst consequences for all those affected can still be prevented.
The MDR entails far-reaching changes for all economic actors and especially for manufacturers of medical devices. Every single medical device must be completely re-evaluated for compliance under the MDR – the majority of which are long-established and safe existing products. This increase in certification effort presents companies with enormous challenges that are not always feasible in practice, exacerbated by often rising costs. The Baden-Württemberg state government has therefore commissioned experts to develop recommendations for action that show how the implementation of the MDR can succeed. Part of these recommendations is to support those companies that manufacture indispensable medical devices and whose loss threatens or has already caused gaps in supply due to a lack of alternatives.
Discontinuation of important medical devices
The burdens are not only momentous for the manufacturers of medical devices. Mutter emphasized in her presentation that the MDR-related discontinuation of important medical devices contradicts the goals explicitly formulated in the regulation of ensuring a high level of safety and health protection while promoting innovation. Both goals are inextricably linked and must be pursued with equal priority and in parallel so that patients can continue to receive optimal care in the future. The urgent plea towards Brussels and the member states is therefore to act now. Seeking a solution via national special approvals is not viable, Mutter said. This is because these are neither designed for the long term nor for EU-wide or global marketing, and they also do not enable any innovative new developments.
Spectaris takes a positive view of the fact that the European Commission has set up a task force. However, the association emphasizes that little is yet known about the exact scope and its work assignment and that its focus must be to ensure the supply of existing and niche products even after 2024.