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IMDRF consultation: Terminologies for categorised adverse event reporting

13 August 2018

This consultation closed on 12 October 2018.

The International Medical Device Regulators Forum (IMDRF) working group on Adverse Event Terminology seeks to improve, harmonise and, where necessary, expand the terminology and systems being used to code information relating to medical device adverse events.

Their current work item also includes establishing 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.

This IMDRF working group sought comments from interested parties on the following:

The TGA (together with all other working group members) invited interested parties to comment on the document.

Deadline for submissions

Interested parties should respond directly to the working group chair (Mr. Hiroshi Ishikawa) by 12 October 2018.

Do not send your responses to the TGA.

Instructions on making comments and any enquiries are included on the IMDRF website linked above.

Further information about IMDRF consultations

Further details about current (and closed) consultations, including how to make submissions, are available on the Consultations page of the IMDRF website.