On 5 May 2025, version 7.3.1 of the European form for reporting serious incidents (MIR) has been published by the European Commission.
On 5 May 2025, the European Commission published version 7.3.1 of the Manufacturer Incident Report (MIR). After a six-month transition period, the new form will be mandatory from 1 November 2025 – Switzerland will also make the corresponding change. Manufacturers should finalise the change now to avoid media breaks and queries.
Quick Reminder: What's Changing with MIR Version 7.3.1
The latest version of the form for reporting serious incidents does not contain any fundamental changes to the previous version. However, there are some design changes: Among other things, mandatory fields 2.2, 4.3.1 and 4.3.2 (device type, identification of similar incidents) have been revised. Some help features have also been added, such as explanations of technical terms within the document and predefined options for some fields.
For a more complete overview of the changes, see our article from June 2025.
The MIR document can be used for incident reports in Switzerland and the EU. It remains to be seen whether the British MHRA will also accept European MIR documents as part of its latest updates to post-market surveillance regulations.
Our recommendation
If you are a manufacturer or importer in the EU or Switzerland and have medical devices on the market or are planning to do so, we recommend that you ensure that you comply with the formal requirements for regulatory documentation, such as MIR Form 7.3.1.
Clear documentation, a good eQMS and a secure post-market surveillance system can save you a lot of tedious work. BEO BERLIN assists all manufacturers and importers with regulatory issues, prepares documentation and develops tailor-made QM systems.
Contact us for a free initial consultation!
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