Adverse Event Terminology
The purpose of this working group is to:
- establish IMDRF adverse event terminology including terms for medical device malfunction, evaluation result/conclusion, patient/user outcome, and part/component of a medical device
- support the implementation and the use of the terminology through the provision of guidance documents and training materials
- improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events.
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Do you wish to submit a request to change the AET Terminology? See this page
Work items
Finalisation of the Guidance Document on “Consideration for the selection of IMDRF Adverse Event Terminology (AET) codes and terms”
Development of training material to support the introduction of the Guidance Document on “Consideration for the selection of IMDRF Adverse Event Terminology codes and terms"
Finalisation of the updated Annual Maintenance Standard Operating Procedure (SOP)
Review of the N43 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes and N44 Maintenance of IMDRF AE Terminologies