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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.

IMDRF Adverse Event Terminology Maintenance

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

IMDRF Adverse Event Terminology (Excel Format)

IMDRF AE terminology is provided in Excel format under IMDRF/AE WG/N43 on the 'Documents' page (For the current version, please download the version with the most recent publication date).

Since Edition 4 published on 20 April 2020, all annexes are provided in a new common format. The contents of each column are explained in a README file.

IMDRF Adverse Event Terminology Web Browser

The web browser for IMDRF AE terms ensures user-friendly searching and hence better and more adequate use of terms by reporters/regulators.

Working Group

Working Group Chair: Hiroshi Ishikawa, Japan contact Hiroshi Ishikawa

Working Group Membership: Regulator membership

Australia

  • Amanda Craig (TGA)

Brazil

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

Canada

  • Tanya Hiebert (Health Canada)
  • Richard McAteer (Health Canada)

European Union

  • Jean-François Roche (European Commission)
  • Robin Seidel (Federal Institute for Drugs and Medical Devices, Germany)
  • Claudius Griesinger (JRC)
  • Hubert Chassaigne (JRC)
  • Dimitrios Panidis (JRC)
  • Vittorio Reina (JRC)

United Kingdom

  • Paras Shah (MHRA)

Japan

  • Working Group Chair: Hiroshi Ishikawa (PMDA)
  • Tsutomu Makino (PMDA)
  • Toru Takahashi (PMDA)
  • Takako Niwa (PMDA)
  • Yasuyuki Sakurai (PMDA)
  • Daisuke Tanaka (MHLW)
  • Koutarou Tomita (MHLW)
  • Katsuya Sawadaishi (MHLW)
  • Arisa Nakamura (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