The EU Commission has announced the date which the new MIR Form Template will be made mandatory. The date has been set for 1st May 2026, after which, the old MIR form template will not be accepted by competent authorities and notified bodies.
To offer some background to this update, the European Commission has released an updated version of the Manufacturer Incident Report (MIR) form (Version 7.3.1), which was previously last revised in 2019. This form serves as a standardized template that manufacturers can use to report incidents involving medical devices to the relevant competent authorities.
The new MIR Template can be accessed using the following link
