Updated European Manufacturer Incident Report Version 7.3.1

By Amelia Boldrick and Elizabeth Pugh

An updated version of the Manufacturer Incident Report (MIR) MIR version 7.3.1 form (SB-10781) was published on the European Commission (EC) website on December 22, 2025. 

Background

As our Emergo experts previously reported, an updated version was expected to fix issues identified with the previous version (SB-10573). A complete description of the changes implemented can be found on the changelog. In addition, the XSD and XSL files for the updated version have also been published on the same site. The use of this version (SB-10781) of the form will be mandatory as of May 1, 2026. 

Supporting MIR Guidance/Documentation

There are three resources manufacturers can use to assist with the preparation of the MIR form: MDCG 2023-3, IMDRF coding guidance and the MIR Helptext. 

MDCG 2023-3 further clarifies the vigilance requirements laid out in the regulations. 

As previously reported, IMDRF adverse event reporting terminology and codes are essential to European MIR reporting and other markets worldwide. The guidance (IMDRF/AE WG/N43) offers clarity on the purpose and method of assigning IMDRF terminology to adverse events.

We would like to highlight the MIR Helptext. The EC releases helptext with the MIR form providing invaluable guidance on how to complete each question within the form. 

Common points of confusion

The following are examples we often see of the form not being completed correctly according to the helptext: 

Manufacturers often include a complete device description or intended use statement in field 2.3b. The helptext suggests a very brief description and provides two examples: ‘Hip Implant' and 'Cardiac Marker.’

4.3.1a is a field that some manufacturers may struggle with (note that after June 2025 the alternative field 4.3.2a should no longer be used). The first Annex A code identified in 3.2a should be used for determining similar incidents, except:

• If, after completion of the investigation, the investigation finding is determined, both Annex A and C can be used to identify serious incidents.
• In some cases, the Annex E or F code may be more appropriate. If applicable, the Other field should be chosen with a description in the box that follows. 

Implement MIR 7.3.1 ASAP

We at Emergo by UL recommend that manufacturers implement version 7.3.1 (SB-10781) at this time. 

As manufacturers are aware, global post-market surveillance is a pivotal element of a well-developed and functioning quality management system.  Of course, one element of this is a vigilance system.