Swissmedic releases new guidance and adopts the updated EU MIR form

By Amelia Boldrick and Elizabeth Pugh

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.

Completing MIRs for Swiss incidents

Swissmedic’s new guidance, MU680_20_815 CH Guide Manufacturer Incident Report (MIR), provides detailed instructions to manufacturers on properly completing the form for submissions to Swissmedic.

For manufacturers and producers of systems and procedure packs located outside of Switzerland, in section 1.3.1 of the MIR form, "Submitter of the report", the option "Other, please specify" must be selected and "CH Rep" entered in the adjacent field regardless of who sends the form to Swissmedic. Swissmedic derives the "Submitter of the report" from the sender of the e-mail.

The new version of the form no longer includes CH as a checkbox in section 2.5a (market distribution of device). Therefore, Switzerland should be listed in the “Others” text box. Additionally, in section 3.4 (initial reporter), “Other” should be selected as the country and then check the box and enter CH in the text field.

Lastly, in section 4.3.3.c, serious incidents in Switzerland should be included in the "EE+TR+XI" and “World” fields.

Software requirements and form functionality

Swissmedic requires both the PDF and XML data files when vigilance reports are submitted.  

However, the help text file released with version 7.3.1 indicates Adobe Acrobat Professional is necessary for XML exportation. Although we at Emergo can confirm that some users with Acrobat Standard can export XML data, others may not be able to.

Users who have difficulty  generating an XML file will be pleased to know that Swissmedic will accept PDF-only submissions as long as the form remains active and they can export the XML file themselves upon receipt of the PDF submission.

We at Emergo are aware of other issues that some users encounter in the new MIR and intend to provide further insight as we learn more.  

Concluding remarks

While Swissmedic has released a field safety corrective action form specific to Switzerland, they will continue to use the EU MIR form. Although Switzerland was removed from the European Economic Area countries identified in version 7.3.1, Swissmedic now offers detailed guidance on the use of the new form to report incidents that occur there.

Manufacturers should confirm their vigilance reporting systems are ready to use MIR version 7.3.1 beginning this November for both Switzerland and the EU.