New Manufacturer’s Incident Report PMSV reporting forms - European Commission (Copy)

The European Commission has published a new reporting template for Manufacturer Incident Reports (MIR) for Serious Incidents (SI). The template will become obligatory in November 2025. Many of the changes to the existing template are small, such as changes in wording. However, there are a few substantive changes – including a requirement to specify both the date on which the manufacturer became aware of an incident and the date on which the incident was reported. There is also now a clear requirement to state whether there is a suspected or confirmed relationship between the incident and the device. An MIR guidance document has been published with the new template.