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