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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

Australia

  • Pamela Carter (TGA)

Brazil

  • Maria Gloria Vicente (ANVISA)
  • Sheila Martins Cordovil (ANVISA)
  • Katia Shimabukuro Donath (ANVISA)

Canada

  • Tanya Hiebert (Health Canada)
  • Leanne Moore (Health Canada)

European Union

  • Jean-Fran├žois Roche (European Commission)
  • Claudius Griesinger (European Commission)
  • Tony Sant (MHRA- UK)
  • Graham Nash (MHRA)
  • Robin Seidel (BFARM)
  • Hubert Chassaigne (JRC)
  • Dimitris Panidis (JRC)

Japan

  • Working Group Chair: Hiroshi Ishikawa (PMDA)
  • Mika Togashi (PMDA)
  • Kaori Ogawa (PMDA)
  • Tsutomu Makino (PMDA)
  • Toru Takahashi (PMDA)
  • Takako Niwa (PMDA)
  • Yasuyuki Sakurai (PMDA)
  • Fumihito Takanashi (MHLW)
  • Akimasa Takeuchi (MHLW)
  • Yusuke Ueda (MHLW)

Russia

  • Aysylu Valeeva (Roszdravnadzor)

Singapore

  • Lailing Liew

South Korea

  • Hyeonho Kim (MFDS)

United States of America

  • Nancy Pressly (FDA)
  • Evan Jacobs (FDA)

World Health Organization

  • Anita Sands