In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website. The form introduced novel information requirements such as use of IMDRF adverse event terms and codes or trending data based on relevant similar incidents.
Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)
The new Manufacturer’s Incident Report (MIR) Form has been updated and a copy of the latest version (version 7.2) and detailed guidance/ help text that may assist in completing the form are available on the Commission website.
Based on the additional guidance on the MEDDEV 2.12/1 rev.8 section 4, the current version of the MIR Form included a number of new concepts:
- The information is presented in a new structure.
- Introduces international IMDRF coding/ terminology.
- Introduces a definition of similar incidents and requires similar incidents trend data in a tabular format.
- In preparation for the future EU MDR it also introduces (not mandatory yet):
- the concept of SRN which will be utilized greatly in the future under the new regulations.
- the use of UDI.
The updated version of the MIR Form V 7.2 will become mandatory from January 2020.
However, if you are a manufacturer and have already adapted your IT system to version 7.1, you may use this version until the end of March 2020.