The European Commission has updated the Manufacturer Incident Report (MIR) form to version 7.3.1. This form is used for reporting serious incidents involving medical devices and in vitro diagnostic devices under the MDR and IVDR regulations.
Manufacturers must transition to this updated version by November 2025.
Key changes introduced in MIR 7.3.1:
- Mandatory Terminology Use:
- Annexes E and F of the IMDRF coding system must now be used in all reports
- Annex G codes are now required in final reports
- New Data Fields:
- Separate entries for “Device Description” and “Nomenclature Text” (previously combined)
- New fields to indicate if a legacy product is still marketed post-MDR/IVDR
- Territorial Changes:
- UK and Switzerland have been removed from the EEE country list
- Northern Ireland has been added
- Technical Improvements:
- Direct XML saving functionality
- Enhanced submission process with built-in email submission option
- Swissmedic Adoption:
- The Swiss authority Swissmedic has formally adopted MIR 7.3.1
- It becomes mandatory for all incident reports involving Switzerland starting November 2025
Manufacturers are advised to begin updating their internal processes and systems to comply with this upcoming requirement.
For more information, check here the official guidance: https://bit.ly/4kZnzXc
If you require any assistance, contact us at: [email protected]
