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International Medical Device Regulators Forum

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Adverse Events Terminology - Change Request Form

The IMDRF Adverse Event Terminology is always open for Change Requests. The cutoff date for inclusion in the next release is 1 September. The Change Requests will then be reviewed by the IMDRF working group, and the updated terminology and outcome of Change Requests will be published in March. Below are the IMDRF AE terms: Annex A: Medical Device Problem Annex B: Cause Investigation - Type of Investigation Annex C: Cause Investigation -...