The European Commission has published the updated Manufacturer Incident Report (MIR) PDF form, version 7.3.1, which will become mandatory on November 2025. This updated version features key clarifications and newly added fields designed to enhance reporting efficiency and ensure alignment with evolving regulatory expectations.
Notable changes include clearer guidance on timelines related to manufacturer awareness dates, new questions concerning medicinal substances, and updated references to Annexes—all of which carry significant implications for your vigilance reporting procedures.
- New manufacturer incident report (MIR 7.3.1. PDF form)
The published MIR form is password-protected, so it may be necessary to unlock it for specific purposes (e.g. translating the form, implementing it into in-house systems).
Should any further information or assistance be required, please do not hesitate to contact MDSS.
