---
title: "Updated Manufacturer Incident Report (MIR) Form 7.3.1 Now Mandatory in the EU"
description: "The European Commission's updated Manufacturer Incident Report (MIR) form 7.3.1 is mandatory across the EU since 1 May 2026, introducing new data fields, usability improvements, and updated XSD/XSL files to standardise vigilance reporting under MDR."
url: https://qbdgroup.com/en/regulatory-updates/updated-manufacturer-incident-report-mir-form-7-3-1-mandatory-eu
type: "Regulatory update"
language: en
published: 2026-06-11
author: "Kirsten Van Garsse"
category: "Regulatory Update"
publisher: "QbD Group"
citation: "QbD Group, \"Updated Manufacturer Incident Report (MIR) Form 7.3.1 Now Mandatory in the EU\", https://qbdgroup.com/en/regulatory-updates/updated-manufacturer-incident-report-mir-form-7-3-1-mandatory-eu"
---
# Updated Manufacturer Incident Report (MIR) Form 7.3.1 Now Mandatory in the EU
> The European Commission's updated Manufacturer Incident Report (MIR) form 7.3.1 is mandatory across the EU since 1 May 2026, introducing new data fields, usability improvements, and updated XSD/XSL files to standardise vigilance reporting under MDR.

The European Commission has introduced an updated version of the [Manufacturer Incident Report (MIR) form 7.3.1](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en), published in April 2026 and mandatory for use since 1 May 2026.

Manufacturers must now ensure that all vigilance reporting in the EU is performed using MIR 7.3.1 versions released from December 2025 onwards, while earlier versions are no longer accepted.

## Key points

- **Mandatory use of MIR 7.3.1:** All incident reports must be submitted using MIR 7.3.1. Acceptable versions currently include those published in December 2025, March 2026, April 2026, and May 2026.
- **Older versions withdrawn:** MIR forms published before December 2025 can no longer be used.
- **Content and usability updates:** The updated form introduces new data fields (e.g. manufacturer awareness date, UDI issuing entity), together with corrections and usability improvements to reduce errors and facilitate completion.
- **Support for system integration:** Updated XSD and XSL files are available to support integration into manufacturer databases and automated reporting workflows, alongside updated helptexts and a changelog.

The updated MIR form is part of ongoing efforts to standardise vigilance reporting and improve data quality across the EU. The introduction of new structured fields and improved usability will support more consistent, complete, and reliable incident reporting, aligning with increased expectations under MDR for post-market surveillance and vigilance activities.

## What does this mean for you?

Manufacturers must ensure that incident reporting processes fully align with MIR 7.3.1, including use of the correct form version and updated data fields.

Vigilance systems and workflows should support accurate data capture (including UDI and awareness dates) and enable efficient completion and submission of reports.
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Source: https://qbdgroup.com/en/regulatory-updates/updated-manufacturer-incident-report-mir-form-7-3-1-mandatory-eu — © QbD Group. Quote freely with attribution and a link back.