European Commission Publishes Third Update of 2026 to MIR version 7.3.1 Report Form

By Amelia Boldrick and Elizabeth Pugh

The European Commission (EC) published (May 7) the third update of the year (SB-11154) to the Manufacturer Incident Report (MIR) form version 7.3.1 for correction. Both PDF and XSD files are affected by the latest update. The EC states that all iterations of the MIR 7.3.1 form from December 2025 (SB-10781) and later can be used until further notice.

A brief history of the MIR version 7.3.1 form

As we announced in May of last year, use of the initially published MIR version 7.3.1 form was intended to become mandatory by November 1, 2025. There was no additional reference displayed on the first PDF form. 

Almost immediately after publication, extensive issues in the form prompted release of the corrected version SB-10573, identifiable from the first release with the addition of the changelog reference to the top of the PDF form. The second and all subsequent forms released can be differentiated from one another by the changelog number at the top of the form.

As rounds of bug discovery and correction prevented mandatory use by the originally planned deadline, updates were released in December 2025 and then monthly  from March 2026.

What has changed in SB-11154?

A bug in section 4.2i (Final comments from the manufacturer on cause investigation and conclusion) has been resolved. The red border was missing while importing XML with combined or final report types.

Additionally, there were two changes to the XSD files: date/version reference updated and a correction to section 4.3.1a.

How will the changes impact reporting?

As of May 1st, the Italian Ministry of Health requires digital MIR submissions via its DISPOVIGILANCE platform. At the time of this update, it is mandatory to upload MIR version 7.3.1 SB-11010 to the platform. 

A glitch when importing data from the XML results in each date field in the webform displaying one day behind.  Users should carefully review all date fields in the webform after uploading data and correct as necessary prior to submission. Emergo by UL has provided this feedback to the Italian Ministry of Health.

Impact in Switzerland and the United Kingdom

Switzerland will also require use of MIR version 7.3.1 in May. However, at the time of this update, the Swissmedic vigilance webpage still hosts 7.3.1 version SB-11010.

MHRA (UK) announced in their MORE portal that version 7.2.1 version of the form should continue to be used except for reports submitted for serious incidents occurring in Northern Ireland. 

Concluding remarks

The additional flexibility in MIR form versions accepted is appreciated as manufacturers incorporate these rapid changes into their complaint management and reporting systems.

Emergo by UL experts continue to monitor vigilance reporting developments globally.