New MIR 7.3.1 form: mandatory from 1 May 2026
The European Commission has updated the MIR (Manufacturer Incident Report) form used by medical device manufacturers to report serious incidents to competent authorities, as required by Article 87 of Regulation (EU) 2017/745 (MDR). Version 7.3.1 is mandatory as from 1 May 2026, and only the versions published from December 2025 onwards are accepted.
Key changes
- IMDRF codes now compulsory (Annexes E and F; Annex G for the final report).
- Separate fields for the date of manufacturer awareness of the incident and the date of awareness of its reportability.
- Identification of the UDI-issuing entity.
- XML format validated through XSD/XSL schemas, for integration into the manufacturer’s systems.
Reporting deadlines (Art. 87 MDR)
- Serious public health threat: no later than 2 days.
- Death or unanticipated serious deterioration in health: no later than 10 days.
- Other serious incidents: no later than 15 days.
What about EUDAMED?
The EUDAMED Vigilance module is not yet operational (it is not among the four modules mandatory from 28 May 2026). In the meantime, the MIR is sent directly to the national competent authority: in Spain, to the AEMPS, by email to psvigilancia@aemps.es.
At MeDev Consulting we can help you adapt your vigilance procedures to the new form. Contact us.
Sources: European Commission – PMSV reporting forms · MDR, Art. 87 · AEMPS