New MIR 7.3.1 form mandatory from November 2025
The European Commission has released the new Manufacturer Incident Report (MIR 7.3.1) form. This updated PDF format will become mandatory as of November 2025 for all manufacturers of medical devices under Regulation (EU) 2017/745 (MDR).
Password-protected PDF form
The MIR 7.3.1 form is password-protected to ensure controlled use. The password can be requested for authorised purposes such as:
- Translating the form
- Integrating the form into internal IT systems
Supporting documentation
Alongside the MIR 7.3.1 PDF, the European Commission provides the following supporting files:
- MIR 7.3.1 form (PDF, password-protected)
- XSD and XSL files for database integration
- Helptext with step-by-step guidance
- Changelog detailing the latest updates
Technical requirements
Please take note of the following technical considerations:
- Some browser plugins may not support interactive PDF forms.
- Recommendation: Download the file and open it locally on your computer.
- Adobe Acrobat Professional is required for digital signature and XML data handling.
Download and further information
For complete details and access to all related documents, visit the official page of the European Commission: PMSV Reporting Forms – European Commission
