[유럽, MDR/IVDR] PMSV reporting forms

MIR PDF 7.3.1

New MIR form - mandatory as from November 2025

• New manufacturer incident report (MIR 7.3.1. PDF form)

The published MIR form is password-protected, so it may be necessary to unlock it for specific purposes (e.g. translating the form, implementing it into in-house systems).

You can request the password for specific authorised uses.

• New manufacturer incident report XSD files and XSL files (for implementation in manufacturer’s databases)
• New manufacturer incident report helptext
• Changelog file.

please note:

• some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there
• Adobe Acrobat Professional is necessary for signing MIR 7.3.1. PDF and for XML data import/export.

 

PMSV reporting forms - European Commission

PMSV reporting forms