EU MIR Manufacturer Incident Report Form v7.3.1: What’s New

The European Commission / Medical Device Coordination Group (MDCG) has published the new MIR (Manufacturer Incident Report) form v7.3.1, which becomes mandatory from 1 May 2026.
It gives companies clear compliance guidance for completing the form and reduces ambiguity and errors. Alongside MIR v7.3.1, a separate downloadable PDF help document was published, adding extensive field-by-field instructions, term definitions and guidance on choosing codes.

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to receive free of charge:

The official MIR v7.3.1 PDF
The official accompanying help document
A Chinese translation of the reporting template
The MIR form is one of the PMSV (Post-Market Surveillance and Vigilance) reporting forms and is used to report incidents involving MDR/IVDR products. Other PMSV forms and templates are also available free of charge:
Field Safety Corrective Action (FSCA)
Field Safety Notice template
FSN (Field Safety Notice) customer reply
FSN distributor/importer reply
Trend report
Periodic summary report

Conclusion

This is a series of educational articles introducing regulations and standards of the FDA, NMPA, GMP, CE MDR/IVDR and MDSAP.

EVERBIZ is happy to share medical device expertise with industry clients, and hopes our extensive practical experience in quality systems and product registration will be helpful.

Let’s contribute together to the development of the medical device industry – if you have any questions or needs, please contact us.

More articles:
Introduction to EU AI Medical Device Compliance
Medical Device Software Terminology in the EU and US Explained
Similarities and Differences Between the GDPR and the EU Data Act
A Data Protection Impact Assessment Template for EU Medical Device GDPR
Regulations on Clinical Trial Design for AI-Assisted Detection Products in the EU
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Shanghai: Room 909, Building 1, Lane 111 Luxiang Road, Baoshan District, Shanghai, China; Germany: Landsberger Str. 155, 80687 München, Germany
Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria
Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520

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