MIR Form V7.3.1: prepare for the new version by November 2025

The European Commission has published version 7.3.1 of the MIR (Manufacturer Incident Report) form, which will become mandatory from November 2025. This update is part of a drive to improve the quality of vigilance data, prepare for interoperability with EUDAMED, and harmonize internationally with the latest IMDRF standards.

Objectives of version 7.3.1

This evolution addresses several major issues for medical device manufacturers:

• Reinforce the quality and traceability of serious incident reports
• Prepare for integration into the future EUDAMED vigilance module
• Align reports with international standards (IMDRF)

The main new features of V7.3.1

🗓️ Better management of reporting deadlines

The form now clearly distinguishes:

• The date on which the manufacturer becomes aware of the event
• and the date on which the event becomes notifiable according to regulatory criteria.

This provides greater transparency on response and reporting times.

🧾 IMDRF codes updated

The new codes enable a more accurate and harmonized classification of adverse events on an international scale.

🖥️ Enhanced XML format

The structure of the MIR file has been revised to facilitate automated exchanges with EUDAMED, thanks to a machine-readable format that optimizes report processing by the authorities.

❌ UK section deleted

The section dedicated to the United Kingdom has been removed, in line with its exit from the European Union and the gradual separation of regulatory systems.

✅ Enhanced field standardization

Form fields are now more strictly defined:

• Updated drop-down lists
• Automatic consistency checks
• Fewer validation errors during submission

What manufacturers need to anticipate

To be ready by November 2025, there are several concrete actions to be taken:

1. Update your internal material safety procedures (SOPs) to incorporate the new features of V7.3.1.
2. Adapt your IT tools to generate compliant XML files.
3. Train your teams to meet the new requirements, in particular with regard to date distinction and the use of IMDRF codes.
4. Prepare to export to EUDAMED, even if the vigilance module is not yet fully operational.

A step towards more modern, harmonized vigilance

With this version of the MIR form, the European Commission is pursuing its drive to make vigilance more transparent, automated and integrated on a European and international scale. By preparing now, you can ensure your organization's compliance and facilitate future exchanges with the competent authorities.

Need support?

Would you like advice on updating your vigilance processes? Contact our team for a customized audit or training.