EC publishes new version of Manufacturer's Incident Report
The European Commission publishes a new version of the Manufacturer's Incident Report (MIR 2020).
The new form becomes mandatory for manufacturers certified under the MDD 93/42/CEE starting January 1, 2020.
The new MIR format not only integrates the new requirements for incidents reporting under the European regulations (EU) 2017/745-746, but also reinforces the use of the harmonized nomenclature (coding and terminology) for the description of events, their causes and effects on users recommended by the International Medical Device Regulatory Forum (IMDRF) for incidents that involve medical devices.
You find the new form of the Manufacturer's Incident Report (MIR 2020) here.