New MIR Form 7.3.1 Accepted by Swissmedic: Key Updates for Medical Device Manufacturers

On May 5, 2025, the European Commission released version 7.3.1 of the Manufacturer Incident Report (MIR) form used for reporting serious incidents involving medical devices. This updated version reflects the latest EU requirements for post-market surveillance and incident reporting. 

Swissmedic, the Swiss authority responsible for monitoring medical device safety, has confirmed that MIR version 7.3.1 is now accepted for incident reporting in Switzerland—provided the form is completed in accordance with the CH guide, which outlines Switzerland-specific content and reporting requirements. 

Manufacturers are encouraged to begin using the new version immediately. However, from November 2025, the use of version 7.3.1 will become mandatory for reporting serious incidents in Switzerland. 

Swissmedic has made both the updated MIR form and the CH guide available on its website under the Incidents section: www.swissmedic.ch/md-materiovigilance-manufacturers  

Manufacturers and authorized representatives should familiarize themselves with the updated documentation and ensure internal procedures and templates are updated well ahead of the November deadline.