The BVMed Legal Symposium offered exciting insights into current regulatory developments in the medtech sector - and the rare opportunity to take a look behind the political and legal scenes.
It was particularly impressive to see how much has already been set in motion - and how actively concrete solutions are being worked on.
A key topic was the urgently awaited reform of the MDR, which is based on the so-called 9-state paper. The aim is to reduce bureaucracy and make re-certification easier - especially for small and medium-sized companies. These are currently under enormous pressure: the regulatory requirements apply equally to everyone, regardless of size or resources. The call for pragmatic, practicable solutions was correspondingly loud - for example through standardized technical documentation, simplified reporting obligations and faster procedures for supply-relevant products.
Another important topic was the European AI Regulation (AI Act), which will be closely interlinked with the MDR in the future. It became clear that duplication of regulation must be avoided at all costs - and that manufacturers of AI-based medical devices will face new requirements at the same time, for example in the areas of liability and transparency. A new, complex interplay is emerging here, which the industry must monitor closely.
Conclusion: The exchange was not only professionally enriching, but also motivating. We are in.
