May 15th, 2020, the European Commission published an updated version of the Manufacturer Incident Reporting (MIR) Form, version 7.2.1. This publication was accompanied by a “Changelog file” as well as a “Questions and answers document on the implementation of the new MIR form”.
The updated version 7.2.1 of the MIR does not modify the XML structure but it addresses a number of discrepancies that were identified between the PDF and the XML files with version 7.2. It has also adjusted the free text fields so they are now auto expandable to allow a better view of the information provided and the limitation (100,000,000) for the devices on the market has been removed. A change log file is also available on the Commission website with the list of all the changes. In the updated version, the correct formatting for the IMDRF Component Codes (Annex G) was also introduced.
The new MIR form became applicable from 1st January 2020 for the reporting of Incidents under both the EU Directives and the Regulations both for MDs and for IVDs:
- for Incidents under the Directive 90/385/EEC (AIMDD), Directive 93/42/EEC (MDD), and Directive 98/79/EEC (IVDD) (as defined in MEDDEV 2.12/1 Guidelines on a medical devices vigilance system) and
- for Serious Incidents under the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR).
What does this mean to you?
As a company it is vital that you start setting up your systems to allow completion of the elaborated form, including the introduction of the IMDRF AER codes into your systems.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
