Implementation of the European MIR Version 7.3.1 Form Appears to be Delayed until 2026

Amelia Boldrick and Elizabeth Pugh

Some manufacturers may have noticed subtle changes to the implementation timeframe for the Manufacturer Incident Report (MIR) MIR version 7.3.1 form available on the European Commission (EC) website in recent weeks. The site now indicates another revision to the form is forthcoming, and implementation will become mandatory four months from publication. 

Background

The MIR version 7.2.1 form was last updated in 2020 and required a number of updates to accommodate submission in EUDAMED, as well as changes such as Brexit and the expiration of the MRA between Switzerland and the European Union (EU). 

MIR version 7.3.1 challenges

Many stakeholders have experienced major challenges working with both the original release of version 7.3.1, as well as the revised version 7.3.1 SB 10573. Although it is important to remember that Adobe Acrobat Pro should be considered required, there are problems that also impact users already using the required PDF editing software. 

Emergo by UL has communicated the issues we have encountered to the Dutch Health and Youth Care Inspectorate and the European Association of Authorised Representatives (to share with the Medical Device Coordination Group (MDCG) PMSV). From a glitch preventing the retention of distribution data in section 2.5a of the first version 7.3.1 to the inability to select only Annex A for identifying similar serious incidents that persist in section 4.3.1a of version 7.3.1 SB 10573, one thing is clear. The current iteration of 7.3.1 does not work for a significant portion of users. 

Lack of communication about the issues

Unfortunately, beyond the subtle updates to the EC post-market surveillance and vigilance (PMSV) reporting form page, these issues have not yet been broadly communicated to stakeholders. 

Although the MDCG PMSV working group has convened to discuss resolving the issues with version 7.3.1, the updates have thus far been to the EC form page. Over the past few weeks, the website has been revised to reflect the rapid changes to the implementation timeframe. 

What this means

A third version of 7.3.1 is in the works and will be released soon. The timeframe has not yet been publicly announced, but a revision is expected before the end of the year. We anticipate the earliest date for mandatory implementation will be March 2026.

Concluding remarks

We at Emergo by UL recommend that manufacturers continue to use version 7.2.1 until the issues present in 7.3.1 SB 10573 have been resolved. Expect additional updates on the new form and an implementation timeframe as the information becomes available.