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Adverse Event Terminology

The purpose of this Work item is to:

  • to improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events, and
  • to establish IMDRF adverse event terminology composed of the following three parts: terms for medical device malfunction, terms for patient/user outcome and terms for part/component of medical device. (Note: Evaluation terms and code are out of the scope of this Working Group.)

The latest guideline document of Adverse Event Terminology and Coding is available under IMDRF/AE WG/N43 on the 'Documents' page.

Please note that the document will be finalized step by step with the completion of each Annex thereto, i.e., Edition 1 with Annex A, Edition 2 with Annexes A and B, and so forth.

Annexes will be added when finalized after going through public consultations. The Annex currently under consultation is available on the 'Consultations' page.

The maintenance of the final document will be managed via the dedicated 'Adverse Event Terminology Maintenance' web page.

Working Group Chair: Hiroshi Ishikawa, Japan contact Hiroshi Ishikawa

Working Group Membership: Regulator membership

PMDA

MHLW

  • Taku Oohara
  • Noriaki Tokunaga

US FDA

  • Nancy Pressly
  • Evan Jacobs

TGA

  • Pamela Carter
  • Jorge Garcia

Health Canada

  • Mary Raphael

ANVISA

  • Maria Gloria Vicente
  • Guilherme Antonio Marques Buss
  • Stela Candioto Melchior

WHO

  • Anita Sands

European Union

  • Jean-Fran├žois Roche (European Commission)
  • Claudius Griesinger (European Commission)
  • Fabio Faraulo (European Commission)
  • Tony Sant (MHRA- UK)

AHWP

  • WONG Woei Jiuang
  • SASIKALA Devi Thangavelu

Roszdravnadzor

  • Aysylu Valeeva
  • Elena Astapenko

Observer

  • Gulmira Mukhamedzhanova