Swissmedic Releases New Guidance and Adopts the Updated EU MIR Form
Swissmedic Releases New Guidance and Adopts the Updated EU MIR Form
The European Commission has released a new help text file with information for completing the Manufacturer Incident Report (MIR) form aimed at improving medical device safety.
We are deeply committed to upholding quality, safety, and compliance. Our goal is to empower our clients in the development and marketing of products that adhere to the utmost standards, fostering both patient safety and consumer confidence.
Completing Manufacturer Incident Reports (MIRs) for Swiss Incidents
Swissmedic has issued updated guidance (MU680_20_815 CH Guide Manufacturer Incident Report – MIR) outlining how manufacturers should complete MIR forms for incidents occurring in Switzerland.
For manufacturers or producers of systems and procedure packs based outside Switzerland, section 1.3.1 (“Submitter of the report”) of the MIR form requires selecting “Other, please specify” and entering “CH Rep” in the provided field, regardless of who submits the form. Swissmedic determines the actual submitter based on the email sender.
In the updated version of the form, the checkbox for Switzerland has been removed in section 2.5a (device market distribution). Instead, Switzerland should now be listed in the “Others” field. Similarly, in section 3.4 (initial reporter), select “Other” as the country, tick the corresponding box, and input “CH” in the text field.
For section 4.3.3.c, serious incidents occurring in Switzerland must be included under both “EE+TR+XI” and “World” categories.
Software Requirements and Form Submission
Swissmedic requires both the PDF and the XML data file when submitting vigilance reports. The help text for MIR version 7.3.1 states that Adobe Acrobat Professional is needed to export the XML file. However, Emergo has found that some users can successfully export XML files using Acrobat Standard, while others may face limitations.
If users are unable to generate an XML file, Swissmedic will accept PDF-only submissions, provided the form is active and allows Swissmedic to generate the XML themselves upon receipt.
Final Notes
Although Swissmedic has issued a separate field safety corrective action form for use in Switzerland, the EU MIR form remains in use. Despite Switzerland’s removal from the list of European Economic Area countries in version 7.3.1, Swissmedic now offers clear guidance for reporting incidents occurring in Swiss territory.
Manufacturers should ensure their systems are updated to support MIR version 7.3.1 by November for reporting in both Switzerland and the EU.
