IMDRF Updates Terminology for Reporting Adverse Events in Medical Devices

The International Medical Device Regulators Forum (IMDRF) has published an update to the terminology for Adverse Event Reporting in Medical Devices. Version 2025 incorporates changes requested during the 2024 maintenance cycle, aiming to standardise and improve the classification of adverse events in the medical device sector.

The new version includes:

✔ Appendix A: 3 new terms added, 16 terms modified, and 3 removed.

✔ Appendix B: 7 new terms added and 1 removed.

✔ Annex C: 13 terms modified.

✔ Annex D: 3 terms modified.

✔ Annex E: 19 new terms added, 13 modified and 3 removed.

✔ Annex F: 6 new terms added, 8 modified and 1 removed.

✔ Annex G: 2 new terms added and 3 modified.

The update to IMDRF terminology reinforces the importance of global harmonisation in adverse event reporting, enabling manufacturers, regulators and healthcare professionals to use standardised terminology to report and investigate incidents involving medical devices more efficiently.

Requests for changes for the next cycle can be submitted until 1 September 2025.

Please follow the link for detailed information: https://www.imdrf.org/documents/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes