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IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3), G

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A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Medical Device Adverse Event Terminology Working Group is provided below for public comment.

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

Consultation documents

IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Draft for Public Consultation
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3) - Draft for Public Consultation
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex G - Draft for Public Consultation

Please use the comments template to provide comments on the Proposed Documents and send comments to Mr. Ishikawa via e-mail: imdrf-aewg-chair@pmda.go.jp with the subject line 'IMDRF Consultation'

Comments - IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4)