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Updated Adverse Event Reporting (AER) codes/terms published by IMDRF

Posted on 01.04.2021

The International Medical Device Regulators Forum (IMDRF) published an updated version of the Adverse Event Reporting (AER) codes and terms on 2 March 2021 which are used in the EU Vigilance reporting and recently implemented in the US eMDR advancing global alignment.

Edition 5.0 incorporates the Change Requests received for the 2020 maintenance cycle.
• The release notes document provides a quick overview of the changes in all Annexes.
Appendix B: Change Log contains a complete list of comments and IMDRF decisions on the request changes.

Please consult the full list of IMDRF/AE WG/N43 FINAL:2021 Updated Annexes (Edition 5.0) here.

The AER terminology web browser has also been updated to incorporate the latest changes.
The deadline for Change Requests for next year’s maintenance cycle is 1 September 2021 and the next publication of updated/new codes in February/March 2022