MANUFACTURER’S INCIDENT REPORT

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MANUFACTURER’S INCIDENT REPORT

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:

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

Merc can support you in the implementation of the new regulatory requirements.  In case of need please contact us info@merc21.it or click here: https://www.merc21.it/regulatory-detail.asp/l_en/id_43/manufacturer-s-incident-report.html