EU MDR (Medical Device Regulation)

The EU Medical Device Regulation (MDR), Regulation (EU) 2017/745, sets the requirements a medical device must meet to be placed on the EU market. It replaced the Medical Devices Directive and the Active Implantable Medical Devices Directive, and it has applied since 26 May 2021, one year later than first planned. Its companion, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), has applied since 26 May 2022, according to the Commission's medical devices page.

Compared with the directives, the MDR raises the bar in four ways:

• Stronger clinical evidence and clinical evaluation requirements, especially for higher-risk classes.
• Closer scrutiny of notified bodies, which assess conformity for most devices above the lowest risk class.
• Unique Device Identification and registration in EUDAMED, the European database on medical devices.
• Post-market surveillance and vigilance duties for the whole life of a device, and a named person at the manufacturer responsible for regulatory compliance.

The transition has been extended. Regulation (EU) 2023/607, published on 20 March 2023, lets devices certified under the old directives stay on the market until 31 December 2027 for higher-risk devices and 31 December 2028 for medium and lower-risk devices, provided manufacturers meet conditions showing they are moving to the MDR, and it removed the separate "sell-off" deadline for devices already in the supply chain.

For regulatory affairs teams, those dates sit alongside other clocks. The EU AI Act treats AI embedded in medical devices as high-risk, and after the 2026 omnibus those obligations apply from 2 August 2028, the same year the last MDR transition period ends. Tracking both as dated lifecycle stages avoids planning against a deadline that has already moved.

This entry is general information, not legal advice.