[Medical Device Regulation as current challenge for the legally safe introduction of new technologies]

The main goal of the Medical Device Regulation (MDR) is the improvement of patient safety by laying down rules concerning the approval of medical devices for human use in the European Union. The MDR contains an extension of the conformity assessment procedure for products in the higher risk categories IIb and III. The clinical testing and assessment are regulated more strictly by e.g. the scrutiny process conducted by expert panels following the technical certification. The demand for documentation is vastly increasing due to more detailed registration (UDI) and an extension of post-market surveillance. The German Society of Surgery (DGCH) and the German Society for Biomedical Engineering have already defined a staged concept for innovation testing and clinical assessment during finalization of the MDR that contains the highest level of patient safety while simultaneously maintaining the potential for innovation. Essential elements are present in the MDR and can be implemented in a targeted way. The 3‑year phase of national MDR-implementation must be used for a proactive adaptation. The DGCH is represented in the advisory council of the Federal Ministry of Health (BMG) by the Association of the Scientific Medical Societies in Germany (AWMF). The aim is a responsible harmonization of national structures with the regulations of the MDR by the construction of specific registries which should be the responsibility of medical societies. The early integration of health technology assessment will be of importance during the planning phase of product development to facilitate a positive decision on reimbursement.