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IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes - Annex B

A Proposed Document has been released by the International Medical Device Regulators Forum (IMDRF) Adverse Events Terminology Working Group. Green text has been used to indicate where the text of this version varies from previously published Final Document IMDRF/AE WG/N43FINAL:2017 (including Annex A).

This consultation closed on Wednesday 31 May 2017.

Working Group Chair: Hiroshi Ishikawa, Japan

Thank you for your contribution aiming at the validation of the IMDRF document.

Consultation documents

Please use the comments template to provide comments on the Proposed Document and email comments to

Comments - PD1 Annex B N43 - IMDRF Terminologies for Categorized AER terms, terminology and codes - March 2017 (xlsx, 18kb)