From January 2020 the updated version of the Manufacturer’s incident report form V 7.2 will become mandatory, as per indicated in “Additional guidance regarding the vigilance system as outlined in MEDDEV 2.12-1 rev. 8”.

The main changes implemented in the new MIR form are the following:

  • 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.

 A copy of the updated form (the latest version) and detailed guidance/ help text that may assist in completing the form are available on the Commission website:

Merc can support you in the implementation of the new regulatory requirements.  In case of need please contact us or click here: