The International Medical Device Regulators Forum (IMDRF) has announced the release of its 2025 document on “Terminologies for Categorized Adverse Event Reporting,” introducing significant updates for medical device manufacturers, regulatory bodies, and healthcare professionals.
Key Updates in the 2025 Revision
The revised document highlights a comprehensive overhaul of adverse event reporting terminologies. Several annexes see the addition of new terms, modifications to existing ones, and the retirement of outdated terms. Here’s a breakdown of the updates across Annexes A through G:
- Annex A
- Added 3 new terms
- Modified 16 terms
- Retired 3 terms
- Annex B
- Added 7 new terms
- Retired 1 term
- Annex C
- Modified 13 terms
- Annex D
- Modified 3 terms
- Annex E
- Added 19 new terms
- Modified 13 terms
- Retired 3 terms
- Annex F
- Added 6 new terms
- Modified 8 terms
- Retired 1 term
- Annex G
- Added 2 new terms
- Modified 3 terms
These updates aim to enhance clarity, accuracy, and global consistency in adverse event reporting for medical devices.
Additional Resources
Detailed information about the affected terms for each annex is available via a link shared in the official IMDRF document. Stakeholders are encouraged to review these changes to ensure compliance and alignment with the updated terminologies.
This latest update underscores the IMDRF’s ongoing commitment to refining the framework for adverse event reporting, supporting patient safety, and improving global regulatory practices for medical devices. Medical device manufacturers and healthcare professionals should take note of these changes to stay informed and adapt their reporting systems accordingly.
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