[Emergo, UL] Swissmedic releases new guidance and adopts the updated EU MIR form

As mentioned in our previous regulatory update, the European Commission (EC) released (May 5) the long-awaited version 7.3.1 of the Manufacturer Incident Report (MIR) form to report serious incidents. Additionally, the EC has also published a new help text file with information on completing the form, as well as the corresponding XSD and XML schema files to facilitate the integration of complaint management software with the new form.

 

Swissmedic has now adopted this MIR form and will likewise require its use as of November 2025.

 

 

Swissmedic releases new guidance and adopts the updated EU MIR form | Emergo by UL

Swissmedic releases new guidance and adopts the updated EU MIR form