On May 5, 2025, the European Commission published version 7.3.1 of the Manufacturer Incident Report (MIR) form, along with accompanying help text, XSD/XSL files, and a changelog. This updated form is intended for reporting serious incidents under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). While use of the new form is optional until November 2025, it will become mandatory thereafter.
Key Updates in MIR 7.3.1
Mandatory IMDRF Codes: The form now requires International Medical Device Regulators Forum (IMDRF) Annex E and F codes, with Annex G codes needed for final reports.
Separate Awareness Dates: Distinct fields have been added for the date the manufacturer became aware of the incident and the date they recognized it as reportable.
UDI Issuing Entity Identification: Section 2 now includes fields to specify the Unique Device Identification (UDI) issuing entity.
Device Description & Nomenclature Fields: Device description and nomenclature are now captured in separate fields, improving clarity.
Legislation Applicability: Manufacturers can indicate if the applicable legislation is unknown or if a legacy device continues to be marketed post-regulation application.
Market Distribution Adjustments: Great Britain and Switzerland have been removed from the list of European Economic Area (EEA) countries in the market distribution section, while Northern Ireland has been added.
Technical Considerations
Form Accessibility: The MIR 7.3.1 PDF form is password-protected. Manufacturers can request the password for authorized purposes such as integration into internal systems or translation.
Software Requirements: Adobe Acrobat Professional is necessary for completing and digitally signing the form, as well as for XML import/export functions. Some browser-based PDF viewers may not support interactive features; it’s recommended to download and open the form locally.
It is important to note that MIR 7.3.1 is not currently compatible with the EUDAMED vigilance module. Manufacturers cannot use the XML output from this form for direct upload or submission in EUDAMED. The European Commission is expected to release an updated version of the MIR form to address EUDAMED compatibility before mandatory EUDAMED use.
Manufacturers are encouraged to familiarize themselves with the new form and update their internal processes accordingly. The use of MIR 7.3.1 will become mandatory starting November 2025.
