The European Commission published new Templates for Manufacturers to report Serious Incidents under the MDR/IVDR and Incidents under the MDD/AIMDD/IVDDD.
This does not only include an integration of the new legislation but it also strengthens the internal harmonized communication concerning incidents by also using the global harmonized categories published by the IMDRF.
As a consequence the template now includes 12 pages....
The version 7.1 of the Template now also integrates the new aspects for incident reporting under the MDR:
- EUDAMED Number
- PMCF / PMPF
- UDI-DI, UDI-PI, Basic UDI, Unit of Use UDI-DI
- MDR/IVDR Classification
- IMDRF Medical Device problem Code, Health Effect, Cause investigation
The new MIR form can be used as of January 1st 2019.
A 12-month transition period is foreseen before the new form becomes mandatory January 1st 2020: