TÜV Association criticizes EU plans to reform Medical Device Regulation, citing patient safety risks

Summary

The European Commission is proposing reforms to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) aimed at relieving manufacturers, accelerating procedures, and reducing bureaucracy. However, the TÜV Association, represented by spokesperson Mark Küller, strongly criticizes the proposals. Key concerns include: the reduction of unannounced audits which endangers patient safety, the requirement for notified bodies to certify products they haven't physically inspected, and the overall weakening of safety standards in favor of industry interests. Küller argues that the reforms prioritize speed and cost-cutting over patient protection, and warns that fewer inspections will lead to increased risks for patients.