Regulatory Affairs & Life Science

MIR 7.3.1: Everything Manufacturers Need to Know Before November 2025


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The new version of the Manufacturer Incident Report (MIR 7.3.1) is now available and will become mandatory in the EU and Switzerland starting November 2025 for the reporting of serious incidents involving medical devices and IVDs. In this episode we cover:
  • the main updates (new fields, IMDRF codes, geographical and technical changes);
  • key differences from the previous version;
  • what manufacturers should do now to prepare.
A must-listen to stay ahead of the changes and ensure compliance by the deadline.
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Regulatory Affairs & Life ScienceBy Di Renzo Regulatrory Affairs