European Commission Updates MIR 7.3.1 Vigilance Reporting Forms

The European Commission has published an update to the Manufacturer Incident Report (MIR) PDF form version 7.3.1, including clarification on which versions remain acceptable for vigilance reporting under the EU MDR and IVDR.

According to the Commission, the new MIR form is mandatory from 1 May 2026.

The following MIR 7.3.1 versions are currently accepted:

• December 2025 (SB-10781)

• March 2026 (SB-11010)

• April 2026 (SB-11154)

• May 2026 (SB-11154)

The Commission also confirmed that MIR 7.3.1 versions published before December 2025 can no longer be used.

In addition to the updated PDF form, the Commission published:

• Updated XSD and XSL files for implementation in manufacturers’ databases

• New MIR helptext documentation

• A changelog file related to SB-11154

The Commission notes that the MIR PDF form is password protected. Manufacturers requiring integration into internal systems or translation of the form may request the password for authorised uses.

Manufacturers using automated vigilance workflows or XML-based reporting systems should verify compatibility with the updated XSD/XSL files and ensure only accepted MIR versions remain in use.

The Commission also highlighted that some browser plugins may not be compatible with the PDF forms and that Adobe Acrobat Professional is required for saving, signing, and XML import/export functionalities.

Read the full document below.