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

A Proposed Document has been released by the International Medical Device Regulators Forum (IMDRF) Adverse Events Terminology Working Group. This includes the proposed third edition of Document N43 and its Annex E & F

This consultation will close on Friday 12 October 2018.

Working Group Chair: Hiroshi Ishikawa, Japan

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

Consultation documents

Please use the Working Group's comments template in Excel Format for public consultation, with reference to the Instruction for commenting, to provide comments on the Proposed Document and email comments to