New serious incident reporting form for medical device manufacturers (MIR 7.3.1)

The European Commission has recently published the MIR 7.3.1 form, which will be required to use from November 2025 for medical device manufacturers. This form aims to harmonize and simplify the serious incident notification process, in line with the requirements of the European Medical Device Regulations.

Main features of the MIR 7.3.1 form:

• Improved structure: The form is now more intuitive, facilitating the collection and analysis of serious incident data.
• Regulatory compliance: It meets the requirements of Articles 87 of Regulation (EU) 2017/745 and 82 of Regulation (EU) 2017/746, ensuring full compliance with European legislation.
• Interoperability: XSD and XSL files are provided to enable seamless integration into manufacturers’ internal systems.
• Accessibility: Although the PDF form is password-protected, it is available for specific uses such as translation or integration into internal systems. Manufacturers can request the password via the European Commission website.

Manufacturers are encouraged to familiarize themselves with this new form and prepare their organization for its obligatory implementation.

DOWNLOAD THE MIR FORM