IMDRF · International guidance

IMDRF/AE WG/N43:2025

Terminologies for Categorized Adverse Event Reporting (AER)

International Medical Device Regulators ForumIMDRFTechnical guidance

International guidance

This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.

Source identity

Issuing body: IMDRF
Reference: IMDRF/AE WG/N43:2025
Published (source metadata): March 3, 2025

About this guidance

Terminologies for Categorized Adverse Event Reporting (AER)

Standardized terminologies, terms, and codes for categorized adverse event reporting. Enables harmonized global vigilance data exchange.