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

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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

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

Consultation documents

N43 Edition 3 - IMDRF terminologies for categorised Adverse Event Reporting (AER): terms, terminology, structure and codes
N43 Edition 3 - Annex E Health Effect - Clinical Signs, Symptoms and Conditions Terms and Codes
N43 Edition 3 - Annex F Health Effect - Health Impact Terms and Codes

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 imdrf-aewg-chair@pmda.go.jp.

Comments template - N43 Edition 3 - IMDRF terminologies for Categorized Adverse Event Reporting (AER): terms, terminology, Structure and Codes, and Annex E and F
Instructions for commenting