New version of the MIR form (v7.3.1) published on June 4 reinforces alignment with IMDRF coding
On June 4, 2025, the European Commission published the revised version 7.3.1 of the MIR (Manufacturer Incident Report) form, used for reporting serious incidents related to medical devices and IVDs under the MDR and IVDR. This revision aims to strengthen international harmonization and improve the quality of post-market surveillance data.
What changes with version 7.3.1?
Enhanced integration of IMDRF codes: the use of these codes is now mandatory in various sections of the form, such as type of problem, clinical event, investigation and components involved;
Requirement of UDI-DI and UDI-PI identifiers to improve traceability;
Reinforcement of the sections dedicated to the manufacturer's research and conclusions;
Greater detail in monitoring similar occurrences and the number of devices on the market;
Optimized fields for customized devices, software and implantables.
Application and obligations
The new template applies to all manufacturers and authorized representatives operating in the EEA, Turkey and Northern Ireland. Its use complies with the notification deadlines laid down in the MDR and IVDR, and is intended for submission to the competent authority or, in future, via EUDAMED.
To ensure that your surveillance processes are up to date and compliant, please contact us.
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