Dear Members, please be advised that the MDCG have updated the Manufacturer Incident Reporting form (MIR form) to version 7.3.1 which will become mandatory from November 2025 (6 month transition). This includes updates for machine to machine data transfers.
Note 1 : the form is not compatible with EUDAMED, and can not be used to generate XML output files for input into EUDAMED, to report serious incidents.
Note 2: Adobe Acrobat Professional is required to sign MIR form 7.3.1 pdfs and to import/export the file as an XML file.
Note 3: The EC/MDCG are aware that the when the EUDAMED Vigilance module goes live and is mandatory, that many SMEs are requesting a compatible MIR form, as an alternative to direct data entry into EUDAMED, and most do not have software supporting machine to machine transfer for vigilance reporting. MedTech Europe continue to advocate and work with MDCG on this issue, and have already flagged with MDCG that having to implement the changes required for version 7.3.1 and a future EUDAMED compatible form is burdensome and time consuming and will likely require the same manufacturer resources to implement and completed verification and validation of the changes.
I’ll be asking MHRA for their feedback on the use of MIR 7.3.1 as it will be required for reporting on incidents in Northern Ireland.
