Effects of MDR on Legacy Medical Devices 2025 05 01

Описание: MDR & Legacy Medical Devices – Are You Ready for the Clinical Evidence Requirements?
The EU Medical Device Regulation (MDR) brings significant changes, especially for legacy devices already on the market. One of the most critical updates is the mandatory generation of clinical evidence—not just once, but as an ongoing process throughout the product’s life cycle.
Given the time and complexity involved in collecting robust clinical data, early identification of clinical evidence gaps and timely development of a Post-Market Clinical Follow-up (PMCF) Plan can save manufacturers considerable costs and time.
🔄 Remember: Clinical evidence isn’t a one-time requirement. Through Post-Market Surveillance (PMS) and PMCF activities, manufacturers must continuously monitor, evaluate, and update their data to maintain MDR compliance.