IMDRF Adverse Event Report (AER) Terms and Codes Updated

The IMDRF reviews AER revision requests annually and updates the codes as needed. The process to request code revisions is outlined here, and the cutoff is September 1 of each year. Revised codes are typically updated in early March of each year. Manufacturers should verify they are using the correct codes when reporting vigilance. All AER codes are available here.

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.