Europe, 02 January 2026 — The European Commission has released a critical update to the Post Market Surveillance (PMSV) reporting framework, introducing a new Manufacturer Incident Report (MIR) form and setting a strict deadline for compliance.
WHAT’S NEW IN THE MANUFACTURER INCIDENT REPORT ?
The European Commission has published MIR PDF 7.3.1, an updated version of the Manufacturer Incident Report. This update, released on December 22, 2025, is accompanied by a new changelog (SB 10781) and technical files for database implementation.
Crucially, manufacturers have a designated transition period before this new standard becomes enforced.
- The Deadline: The new MIR form will become mandatory as of May 1st, 2026.
KEY HIGHLIGHTS FOR MANUFACTURERS
To ensure seamless compliance, Regulatory Affairs and IT teams must address the following technical requirements immediately:
- Database Integration: New XSD and XSL files (SB 10781) have been released to support the implementation of the new reporting structure into manufacturers’ internal databases.
- Software Requirements: The Commission explicitly states that Adobe Acrobat Professional is necessary for signing the MIR 7.3.1 PDF and for performing XML data imports/exports.
- Browser Compatibility: Users are advised not to open the forms directly in web browsers due to plugin incompatibility. The files should be saved locally to a computer before opening.
- Password Protection: The published MIR form is password-protected. However, manufacturers can request the password for specific authorized purposes, such as translating the form or implementing it into in-house systems.
ADDITIONAL RESOURCES
Beyond the incident report, the update covers a suite of forms and templates essential for comprehensive vigilance reporting:
- Field Safety: Templates for Field Safety Corrective Action (FSCA) and Field Safety Notices (FSN) are available, including specific reply forms for customers, distributors, and importers.
- Trend Reporting: Updated templates for Trend Reports and Periodic Summary Reports have also been provided.
- Guidance: A new “Manufacturer incident report helptext” is available to assist with the transition.