Regulatory guidance
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
Published Mar 3, 2026
Reference
IMDRF/AE WG/N43
Source
IMDRF
Status
Final
Published
Mar 3, 2026
Languages
EN
As with the 2025 release, the 2026 release of the IMDRF terminology is a consolidated XLS workbook instead of a separate file for each annex. Each annex is provided in a separate sheet within the main file. The structure and layout of each annex sheet is unchanged from the last release.IMDRF/AE WG/N43 FINAL:2020 (below) is the guidance document outlining the concept behind the IMDRF Terminology including terms, definitions and IMDRF alpha-numerical codes to be used for Adverse Event (AE) reporting concerning medical devices and in vitro diagnostics. Annexes A-G provide the detailed terms…
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