New Form for Reporting Serious Incidents Now Also Applicable to Switzerland

On May 5th, 2025, the European Commission published a new version (7.3.1) of the form for reporting serious incidents. This updated Manufacturer Incident Report (MIR) form can also be used for submitting reports to Swissmedic.  

In line with the EU publication, the use of this form will become mandatory for reporting incidents in Switzerland starting November 2025.  

New Guidance for Switzerland Incident Reports

It is essential that the updated MIR form is completed in accordance with Swiss requirements. Swissmedic has released a new guidance document detailing how to complete an MIR, focusing on reports for devices from manufacturers or SPPPs domiciled outside Switzerland and Liechtenstein. The Swiss requirements for these reports are summarized below: 

• Section 1.3.1 “Submitter of the report”: For reports on devices from manufacturers or SPPPs domiciled outside Switzerland/Liechtenstein the option “Other, please specify” must be selected and “CH Rep” entered in the adjacent field. 
• Section 1.3.3 “Authorised Representative”: The contact details of the European authorised representative should be entered. 
• Section 1.3.4 “Submitter’s details”: The contact details of the Swiss authorised representative should be entered. 
• Section  2.5 a “Market distribution of device (region/country)”: Include “Switzerland” in the “others” field. 
• Section 3.4 h “Initial reporter”: For “Country”, select “Other” and specify as “CH”. Detailed contact information is required for hospitals in particular. 
  • Serious incidents that have occurred in Switzerland should be stated in the “Country of serious incident” field.  
  • Serious incidents that have occurred in Switzerland should be included in the “EE+TR+XI” field.
  • Serious incidents that have occurred in Switzerland should also be included in the “World” field. 

See full guidance document: Swiss guidance for Switzerland-specific content. 

MedEnvoy Support  

Manufacturers are encouraged to familiarize themselves with the new requirements and ensure compliance before the mandatory date. 

MedEnvoy offers comprehensive support to customers in navigating the new Manufacturer Incident Report (MIR) forms in Switzerland, where needed, to ensure that their MIR forms are completed and submitted in accordance with the latest regulatory standards. 

For further information, contact us.

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