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

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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).

 

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

Consultation documents

N43-PD1 for Annex B IMDRF Terminology for Categorized AER with Annex B description rev
AE WG (PD1 Annex B)/N43R1 – Annex B
Reference Mapping document

Please use the comments template to provide comments on the Proposed Document and email comments to imdrf-aewg-chair@pmda.go.jp.

Comments - PD1 Annex B N43 - IMDRF Terminologies for Categorized AER terms, terminology and codes - March 2017