On 5 May 2025, the European Commission released an updated version of the Manufacturer Incident Report (MIR) form (Version 7.3.1), a key tool in the EU’s post-market surveillance system for reporting serious incidents and safety actions involving medical and in vitro diagnostic devices.

This update aligns the MIR form with requirements under the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). It introduces several changes to improve the quality and consistency of incident reporting across the EU.

Manufacturers across the medical device sector must prepare for its mandatory implementation in November 2025.

Key Changes

Version 7.3.1 introduces several notable changes, including:

• separate fields identifying the date on which the manufacturer became aware of the incident and the date on which the manufacturer became aware that the incident was reportable;
• dropdown menus for identifying UDI issuing entities to support more precise classification – particularly for legacy devices;
• broadened legislative context fields, including the ability to choose ‘unknown’, allowing manufacturers to indicate uncertainty when identifying the applicable legislation under which the device was marketed; and
• updates to reflect geopolitical changes.

Transition Period and Next Steps

The European Commission has provided a transition period during which both version 7.2.1 and version 7.3.1 will be accepted; however, full compliance will be mandatory starting November 2025.

Manufacturers must ensure they fully understand and implement these changes before the November 2025 deadline by updating their management systems and providing targeted training for staff responsible for incident reporting.

For more information about the above topics, please contact Charleen O’Keeffe, or your usual William Fry contact.

Contributed by Imogen Boles Gray and Olivia Heron