Updated IMDRF Terminologies for Adverse Event Reporting

The overview of International Medical Device Regulators Forum (IMDRF) terminologies for categorized Adverse Event Reporting (AER) (i.e., Medical Device Problem) was updated on April 20, 2024. This update includes an editorial correction to Annex A to reinstate a missing definition. In the latest release, numbered 2024.1, Annex A has been modified to include one new term: A050705. This term refers to a problem associated with the device failing to seal the intended vessel, such as in procedures where the device is intended to provide a seal (e.g., electrosurgical hemostasis).

For more detailed information, you can visit the Technical Document on Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes for further guidance.

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