Adverse Event Terminology

Working Group Chair(s)
Lailing Liew
Health Sciences Authority (HSA)
Singapore
Hiroshi Ishikawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan
Membership
Regulators
Status
Current

The purpose of this working group is to:

  • improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events, and

  • 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.)

Development of common terminology and code related to adverse event of medical device - PDF (68kb)

The latest guideline document of Adverse Event Terminology and Coding is available in the following document:

Technical/Informational document

Work items

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.

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.

Participants

Amanda Craig
Therapeutic Goods Administration (TGA)

Maria Gloria Vicente
Brazilian Health Regulatory Agency (ANVISA)
Rodolfo Navarro Nunes
Brazilian Health Regulatory Agency (ANVISA)
Viviane Vilela Marques Barreiros
Brazilian Health Regulatory Agency (ANVISA)

Leanne Moore
Health Canada
Richard McAteer
Health Canada

Claudius Griesinger
Joint Research Centre (JRC)
Dimitrios Panidis
Joint Research Centre (JRC)
Hubert Chassaigne
Joint Research Centre (JRC)
Jean-Francois Roche
European Commission
Robin Seidel
Federal Institute for Drugs and Medical Devices
Vittorio Reina
Joint Research Centre (JRC)

Coco Nakamichi
Pharmaceuticals and Medical Devices Agency (PMDA)
Hiroshi Ishikawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Yasuyuki Sakurai
Pharmaceuticals and Medical Devices Agency (PMDA)

Elena Borisova
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Joanne Tan
Health Sciences Authority (HSA)
Kai Lun Siaw
Health Sciences Authority (HSA)
Lailing Liew
Health Sciences Authority (HSA)

Da-yeong Ryoo
Ministry of Food and Drug Safety (MFDS)
Hye-Kyung Son
Ministry of Food and Drug Safety (MFDS)
Ji-Young Bang
Ministry of Food and Drug Safety (MFDS)

Graham Nash
Medicines and Healthcare products Regulatory Agency (MHRA)
Paras Shah
Medicines and Healthcare products Regulatory Agency (MHRA)

Evan Jacobs
Food and Drug Administration (FDA)
Nancy Pressly
Food and Drug Administration (FDA)

Anita Sands
World Health Organization (WHO)
Leticia Josefina Megias Lastra
World Health Organization (WHO)