Adverse Event Terminology

Working Group Chair(s)
Nancy A. Pressly
Food and Drug Administration (FDA)
United States of America
Andrea Hanson
Health Products Regulatory Authority (HPRA), Ireland
European Union
Graham Nash (Maintenance Chair)
Medicines and Healthcare products Regulatory Agency (MHRA)
United Kingdom
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.

Trainings

Understanding Adverse Event Reporting is an essential part of ensuring that medical devices on the market are appropriately reported upon should post-market issues and incidents arise. This training may be considered of use to regulatory authorities, manufacturers as well as healthcare institutions.

Participants

Amanda Craig
Therapeutic Goods Administration (TGA)
Katie Burns
Therapeutic Goods Administration (TGA)

Maria Gloria Vicente
Brazilian Health Regulatory Agency (ANVISA)
Stela Candioto Melchior
Brazilian Health Regulatory Agency (ANVISA)

Leanne Moore
Health Canada
Richard McAteer
Health Canada
Taran Nagra
Health Canada

Elke Troeltsch
Federal Institute for Drugs and Medical Devices (BfArM-Germany)
Jean-Francois Roche
European Commission
Kathrin Doerr
Federal Institute for Drugs and Medical Devices (BfArM-Germany)

Coco Nakamichi
Pharmaceuticals and Medical Devices Agency (PMDA)
Morikazu Seki
Pharmaceuticals and Medical Devices Agency (PMDA)

Lailing Liew
Health Sciences Authority (HSA)

Hye-Kyung Son
Ministry of Food and Drug Safety (MFDS)
Kook-Han Kim
Ministry of Food and Drug Safety (MFDS)

Cyrill Reber
Swissmedic
Eva Brombacher
Swissmedic
Sandra Tanner
Swissmedic

Paras Shah
Medicines and Healthcare products Regulatory Agency (MHRA)

Evan Jacobs
Food and Drug Administration (FDA)

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