The European Commission has published Form MIR 7.3.1, which will become mandatory as of November 2025 for all medical device manufacturers operating in the European Union. This initiative is part of an effortto harmonize and simplify the reporting of serious incidents, in accordance with the requirements of the applicable European regulations.
Form MIR 7.3.1 meets the following requirements:
-Article 87 of Regulation (EU) 2017/745 on medical devices (MDR),
– and Article 82 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDDR).
This compliance ensures greater regulatory consistency within the European market.
To enable optimal automation and interoperability, the Commission provides:
– XSD (XML Schema Definition) files,
– and XSL (eXtensible Stylesheet Language) files,
The form is password-protected. The password can be obtained upon request through the European Commission’s official website.