EU MDR's New Timetable: Are You Ready for 2025, 2027, and 2028?

Medical Device Global Market Access · May 30, 2025 · 4m

This episode delves into the crucial extended transition deadlines for the EU Medical Device Regulation (EU MDR), now set for 2027 and 2028. We explore what these extensions mean for manufacturers of legacy medical devices, emphasizing the critical actions that should have been completed by May and September 2024 to benefit from this extra time. The focus for 2025 shifts from new extension-specific filings to the continuous maintenance of an MDR-compliant Quality Management System, robust post-market surveillance, and up-to-date technical documentation, ensuring devices remain safe and that…