Last updated on 4 July 2026
Do you work with or develop medical devices? Then please pay attention to the European rules down in the Medical Device Regulation (MDR).
MDR rules
The MDR rules are intended to improve safety and set stricter requirements for market approval of medical devices, including in-vitro diagnostics. The most important changes are:
• strengthening of the market authorisation system;
• more transparency for patients and better traceability;
• stricter rules for certain products.