New MIR v7.3.1 form – MD & IVD vigilance

The European Commission has released an updated Manufacturer Incident Report (MIR) form.
The use of MIR version 7.3.1 becomes mandatory as of 1 May 2026 for the reporting of incidents related to medical devices (MDs) and in vitro diagnostic medical devices (IVDs).

This update constitutes the new reference for incident reporting and supports the ongoing harmonization of vigilance practices at European level.
Economic operators concerned are encouraged to integrate this updated form into their vigilance processes.

To support its implementation, the European Commission has also made available a dedicated help text document, as well as additional technical resources.

DOWNLOAD THE MIR V7.3.1 FORM & ADDITIONAL RESOURCES