The European Commission has released an updated version of the Manufacturer Incident Report (MIR), version 7.3.1, officially published on 4 June 2025. This update introduces essential changes to the MIR reporting process and will become mandatory starting November 2025 for all manufacturers reporting incidents under the EU Medical Devices Regulations.
This release is part of the broader PMSV (Post-Market Surveillance & Vigilance) framework under MDR and IVDR compliance.
Key Documents Released
Manufacturers are encouraged to review and prepare for implementation using the following newly released resources:
- MIR 7.3.1. PDF form - SB 10499
- New MIR XSD and XSL files for integration into internal systems - SB 10499
- New MIR helptext file for form completion guidance
- Changelog file summarizing updates from the previous MIR version - SB 10499
Note: The published MIR form is password-protected. Manufacturers needing access (e.g. for translation or system integration) must submit a request to obtain the password.
Technical Notes:
- Some browser plugins may not support the PDF form. It's recommended to download and open the file locally.
- Adobe Acrobat Professional is required for signing the PDF form and handling XML import/export functions.
Additional PMSV Reporting Templates (for Reference)
The following forms remain available and are important tools for manufacturers managing field safety and post-market reporting. You may wish to update any internal SOPs with these templates as needed:
Official Source: The New MIR PDF 7.3.1 SB 10499 is published – Update 4 June 2025
Published by European Commission on 5 June 2025
 Form 7.3.1 Published — Mandatory from November 2025){kind=link}