Swissmedic highlights the updated MIR template version 7.3.1 for MDR/IVDR vigilance reporting. Learn how the new requirements impact medical device and IVD manufacturers.

The European Commission has updated the MIR 7.3.1 vigilance reporting forms under the EU MDR and IVDR. Manufacturers should verify accepted versions and updated XSD/XSL files.

Version 7.3.1 of the MIR form, published by the European Commission on June 4, 2025, introduces new requirements for reporting serious incidents involving medical devices and IVDs.