Overview of the Commission’s proposed amendments to Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR)
Publication date: February 25, 2026
Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) are twin regulations issued on the same day, aimed at regulating medical devices sold in the European Union. The MDR governs the making available on the market, placing on the market, and use of medical devices. The IVDR establishes the same framework for in vitro diagnostic medical devices, but also covers the rules for marketing these products (including complaints and adverse reactions).
