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