New MIR Form 7.3.1: Key Update for Incident Reporting under EU MDR

The European Commission has released a new version of the Manufacturer Incident Report (MIR) form-MIR 7.3.1-which will become mandatory for all medical device and IVD manufacturers from November 2025. This update is a significant step in harmonizing and streamlining incident reporting processes across the European Union, in line with the MDR and IVDR requirements.

What’s New in MIR 7.3.1?

• The new MIR form is available as a password-protected PDF. Manufacturers needing to translate the form or integrate it into their internal systems can request the password for authorized uses.
• Alongside the PDF form, the European Commission has published XSD and XSL files. These technical resources are designed to help manufacturers implement the MIR format directly into their databases, facilitating digital reporting and data management.
• A comprehensive helptext and a detailed changelog are provided to guide users through the new form and highlight the latest modifications.

Implementation and Technical Requirements

• The MIR 7.3.1 PDF form requires Adobe Acrobat Professional for electronic signing and for XML data import/export functionalities. This ensures both security and compatibility with regulatory systems.
• It is recommended to save the form locally and open it from your computer, as some browser plugins may not be compatible with the advanced features of the PDF form.

Why This Matters for Manufacturers

The introduction of MIR 7.3.1 reflects the EU’s ongoing commitment to improving post-market surveillance and vigilance reporting. By standardizing incident reporting, the new form aims to:

• Enhance the quality and consistency of incident data collected from manufacturers.
• Support the timely identification of safety issues and trends.
• Facilitate compliance with MDR and enable better oversight by competent authorities.

Support for Manufacturers

MedNet EC-REP GmbH is dedicated to assisting medical device and IVD manufacturers in adapting to these regulatory changes. For questions about the new MIR form, Eudamed requirements, or compliance strategies, manufacturers are encouraged to contact MedNet EC-REP’s regulatory experts.

Further Information

The new MIR form and supporting documentation can be accessed on the official European Commission website under PMSV reporting forms. Manufacturers should ensure they are prepared for the November 2025 deadline and update their internal processes accordingly. MedNet EC-REP GmbH remains committed to supporting the medical device industry through regulatory change and ensuring patient safety across Europe.