New MIR Form 7.3.1 – Mandatory from November 2025

Date

May 12, 2025

Category

EU Regulations

Description

The European Commission has published the new version of the Manufacturer Incident Report (MIR) – Form 7.3.1. Its use will be mandatory for all manufacturers of medical devices and in vitro diagnostic medical devices (IVDs) from November 2025.

The update aims to further standardize and streamline the incident reporting process in the EU – in line with the requirements of the EU MDR and IVDR regulations. The new form includes structural and content adjustments that enable a more precise and transparent assessment of incidents.

Manufacturers should familiarize themselves with the changes early on and adapt their internal processes accordingly.

The European Commission provides further information via the MDCG documents and the EUDAMED portal.