EC Publishes Another Update (SP-11010) to the MIR Version 7.3.1 Form

By Amelia Boldrick and Elizabeth Pugh

The European Commission (EC) published (March 23) yet another version of the Manufacturer Incident Report (MIR) version 7.3.1 with little mention of the update beyond including the date of the form publication on the EC website. This newest version of 7.3.1 is distinguishable from previous versions by its changelog reference SB-11010, which appears on the EC website and the form itself.

Background on previous updates to 7.3.1

As Emergo experts reported last May, the initially released MIR version 7.3.1 form (SB-10573) was set to replace version 7.2.1 and become mandatory for use by November 1, 2025. However, over the following months stakeholders discovered numerous bugs requiring correction in the form, which prevented mandatory use by the originally planned deadline.

A corrected form (SB-10781) was released in December 2025, and mandatory use was then set for May 1, 2026 with the assumption that it would be the version in use come May. That is no longer the case. 

What has changed in SB-11010?

Bugs in sections 2.4 (Risk class of device when placed on market) and 4.3.1a (Use of IMDRF terms and codes for identifying similar serious incidents) have been resolved, as has a visual glitch created when the “Align after import” button disappears after selection. 

How will the changes impact reporting?

Use of SB-11010 becomes mandatory as of May 1, 2026. Fortunately, the changes impact only the PDF report form and not the XSD files necessary for integration of the form within manufacturer’s complaint management systems.

As of March 23, the Italian Ministry of Health began accepting digital MIR submissions via its DISPOVIGILANCE platform. However, at this time they note that only MIR version 7.3.1 SB-10573 is accepted. 

From May 1, 2026, it will be mandatory to upload MIR version 7.3.1 SB-11010 to the platform. Until then, the Ministry will accept other MIR versions via email. 

Impact beyond the European Union

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-10781.

Other vigilance news

On March 3, 2026 the International Medical Device Regulators Forum (IMDRF) released its 2026 update to adverse event reporting codes and terminologies. As with the 2025 release, terminology/code updates are outlined in detail in the 2026 Change Request Log. 

Additionally, this month the U.S. Food and Drug Administration (FDA) announced (March 11) the launch of its Adverse Event Monitoring System (AEMS), which is expected to replace the FDA Manufacturer and User Facility Device Experience (MAUDE) database as the central repository for adverse event reports by the end of May 2026. 

Concluding remarks

It may be a challenge for the enterprise to adjust to another change in the form. Emergo experts continue to monitor vigilance reporting developments globally.