The Future of SMEs in Germany’s Medical Technology Sector: Hope Through MDR Reform?

Medical technology companies in Europe are subject to stringent regulatory requirements under the EU Medical Device Regulation (MDR). Implementation continues to progress slowly, and many companies perceive the regulation as an obstacle to innovation – particularly small and medium-sized enterprises (SMEs). High costs, significant personnel demands, and a lack of planning security pose major challenges for smaller manufacturers and hinder investments in new products and technologies.

Against this backdrop, the European Commission set out in 2024 to reduce bureaucracy, simplify regulatory procedures, and provide targeted relief for SMEs. In December 2025, a proposal to revise the MDR was published. Does it actually contain meaningful improvements for medium-sized medical technology companies? Together with representatives from German manufacturers, we discuss how the reform proposal should be assessed, what further improvements are necessary, and how regulatory frameworks must be designed to safeguard innovation and competitiveness in Germany and Europe. The panel is organized by BVMed with regulatory experts from the Regulatory Affairs Working Group and the association’s head office.

Please note: the lecture will be held in German.

Suppported by BVMed | Bundesverband Medizintechnologie e.V.