Adverse Event Terminology
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:
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.
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.
- Annex A: Medical Device Problem
- Annex B: Cause Investigation - Type of Investigation
- Annex C: Cause Investigation - Investigation Findings
- Annex D: Cause Investigation – Investigation Conclusion
- Annex E: Health Effects - Clinical Signs and Symptoms or Conditions
- Annex F: Health Effects - Health Impact
- Annex G: Medical Device Component
Trainings
Information Session on IMDRF Guidance Document - IMDRF terminologies for categorised Adverse Event Reporting (AER): terms, terminology structure and codes,
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.
Current consultations
Considerations for the Selection of IMDRF Adverse Event Terminology
The objective of this document is to provide further guidance on the correct application and consistent use of the terminology. The document provides guidance for all stakeholders:
• providing general coding principles on reporting incidents using IMDRF codes;