The European Commission has released a revised version of the Manufacturer Incident Report (MIR) form for serious incidents. Version 7.3.1 (build SB-11010) becomes mandatory on 1 May 2026. Manufacturers and their quality teams should review the updated form without delay.
Regulatory background
Under article 87 of the EU Medical Devices Regulation (MDR) and article 82 of the In Vitro Diagnostic Medical Devices Regulation (IVDR), manufacturers are legally required to report serious incidents involving devices placed on the Union market to the relevant national competent authorities (NCAs). Depending on severity, reporting timelines range from two days to fifteen days.
In this context, the European Commission adopted standardised reporting forms – the MIR form is the structured document through which manufacturers discharge their vigilance reporting obligations.
Practical Takeaways
Regulatory affairs and quality teams should take the following steps ahead of the 1 May 2026 mandatory date:
- Download and review MIR form v7.3.1, the accompanying helptext document, and the changelog from the Commission’s PMSV reporting forms page to understand the full scope of changes.
- Update internal procedures and work instructions that reference specific field numbers or form sections — several sections have been reindexed and relabelled.
- Engage your IT or QMS team if the MIR form is integrated into your database systems via XML; update to the new XSD/XSL files before the mandatory date.
- Request the form password in advance if your organisation needs to adapt the locked PDF for in-house use.
The previous form version should not be used for new reports after 30 April 2026.
Source: European Commission
