New Manufacturer Incident Report templates for medical devices available

Date: 13 February 2019

The European Commission has published a new Manufacturer Incident Report (MIR) template, which adopts the Medical Device Regulation MDR (EU) 2017/745. The new template replaces the form in MEDDEV 2.12/1 revision 8 annex 3 and has been restructured and extended in all sections.

Further to the reporting template, a detailed help text is provided, including the tables for the code selection as well as the .xsd files for implementation in the manufacturer’s databases before January 2020.

Click on the following links to download the files: