The new MIR 2020 template entitled “Manufacturer Incident Report (MIR) template for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)” was developed to pave the way for an effective, efficient and transparent vigilance information exchange between manufacturers, competent authorities and notified bodies in the European Union.
Its first version was published by the European Commission last December and, since then, it has been revised twice in order to fix a few code issues or update the information contained. The latest version (7.2) was issued on September 30, 2019.
The new MIR format not only integrates the new requirements for incidents reporting under the European regulations (UE) 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.
The MIR Helptext 2020, contains supporting information structured in six annexes (A through F) useful for filling in the five distinct sections of the MIR form and employs a three-level system coding to help familiarize the user with what is expected in terms of reporting procedure.
The new form becomes mandatory for manufacturers certified under the MDD 93/42/CEE starting January 1, 2020. Until such date, they are urged to review and update, if necessary, their vigilance procedure.
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