European Commission publishes new version of MIR form (v7.3.1)

The European Commission has published the new version 7.3.1 of the MIR (Manufacturer Incident Report) form, accompanied by an updated helptext, which clarifies the requirements for submitting serious incidents under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

Version 7.3.1 introduces relevant adjustments to the structure and mandatory fields of the form, as well as improvements in alignment with the modules of the EUDAMED system, in anticipation of its full operationalization.

Main updates:

• Reinforcement of the definitions of mandatory fields according to the type of submission (initial, follow-up, final reportable or non-reportable);

• Updated reference to IMDRF and EMDN nomenclatures and fields related to UDI, SRN and device risk;

• Inclusion of guidance on PMCF/PMPF investigations, PSR and registration of associated accessories and devices;

• Technical preparation for electronic submission via XML and integration with EUDAMED.

This update has a direct impact on the post-market surveillance (PMS/Surveillance) processes of manufacturers and their authorized representatives, who must ensure the immediate implementation of the new version of the MIR in their reporting systems.

The MIR v7.3.1 form and its supporting document are available on the European Commission portal, but can also be consulted below.