Medical Device Regulation (MDR)

Definition

The EU regulatory framework (Regulation 2017/745) governing the design, manufacture, and distribution of medical devices in the European market, which replaced the Medical Devices Directive (93/42/EEC) with significantly stricter requirements. MDR imposes enhanced clinical evidence requirements, more rigorous conformity assessment procedures, a Unique Device Identification system, and comprehensive post-market surveillance obligations. Compliance with MDR is essential for EU market access and represents a substantial regulatory barrier to entry that adds value to existing certified products.