Background

IMDRF Adverse Event Report (AER) terms and codes are standardized terminology used to classify and report adverse events related to medical devices. Agencies such as the European Notified Bodies and Competent Authorities, UK MHRA, Australian TGA, and US FDA use IMDRF AER codes, and their use helps ensure consistent reporting across different regulatory jurisdictions. Further, use is mandatory in some jurisdictions, e.g., IMDRF ‘medical device problem codes’ are required for serious incident reporting in Europe.

Here you can find the list of countries that have fully or partially implemented ‘IMDRF/AE WG/N43 FINAL:2021 (Edition 5) IMDRF terminologies for categorized Adverse Event Reporting (AER): Terms, terminology structure and codes’.

The IMDRF reviews AER revision requests annually and updates the codes as needed. The process to request code revisions is outlined here (select tab titled “IMDRF Adverse Event Terminology Maintenance”). The cutoff is September 1 of each year.

Revised codes are typically published early March of each year.

Overview

The list of updated adverse event terms is available: HERE

The above link also includes a detailed ‘Release Notes: IMDRF terminologies for categorized Adverse Event Reporting (AER)’ at the bottom of the page. This Excel file provides who requested the change, why, and the IMDRF’s decision.

Below is the high-level summary of changes, link found: HERE