With the official publication of the Manufacturer Incident Report (MIR) PDF version 7.3.1 by the European Commission, post-market surveillance for medical devices and in vitro diagnostics in the EU has advanced significantly. In order to ensure improved reporting and compliance with the changing regulatory environment, this revised form will be required starting in November 2025.
What is the MIR?
Manufacturers can notify EU competent authorities of major incidents involving medical devices and in vitro diagnostics using the MIR standardized form. It facilitates timely communication, risk assessment, and corrective actions, thereby safeguarding public health.
What’s New in Version 7.3.1?
In contrast to MIR 7.2.1, MIR 7.3.1 brings a number of significant improvements:
- EUDAMED Compatibility: The form now supports structured XML submissions for smooth data integration, completely aligning with the European Database on Medical Devices (EUDAMED).
- Removal of UK AER: In light of the UK’s exit from the EU, all references to the UK’s Adverse Event Reporting (AER) have been removed.
- Selection of the Unique Device Identification (UDI) issuing entity: To improve uniformity and clarity, a new single-selection field has been added.
- Split of ‘Become Aware’ Date: To improve transparency and reporting accuracy, MIR version 7.3.1 introduces a new field in addition to the existing one to remove the ambiguity. The updated form now includes a separate field for the “Manufacturer awareness date of reportability”
This allows regulators to distinguish:
- When the manufacturer first learned that an incident had occurred
- When the manufacturer determined the incident was reportable under MDR/IVDR criteria.
Password Protection: The PDF form is now password-protected to ensure data integrity. Manufacturers can request the password for authorized purposes, such as translating the form or integrating it into internal systems.
Technical Files Provided: Accompanying XSD and XSL files are available to facilitate integration into manufacturers’ databases.
Comprehensive Helptext: A Thorough helptext document that outlines required fields and provides instructions on correctly filling out the form is supplied.
Technical Considerations
Software Requirements: Adobe Acrobat Professional is necessary for signing the MIR 7.3.1 PDF and for XML data import/export functionalities.
Accessing the MIR 7.3.1 Resources
Manufacturers can access the MIR 7.3.1 form, along with the associated technical files and helptext, through the European Commission’s official website:
PMSV Reporting Forms – European Commission
Final Thoughts
The EU’s medical device vigilance system has advanced significantly with the release of MIR PDF 7.3.1. In order to guarantee compliance and support the ongoing safety and effectiveness of medical devices on the European market, manufacturers are urged to become acquainted with the new form and its requirements well in advance of the November 2025 deadline.
