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Adverse Event Terminology Maintenance

  • The terms in the Annexes of the final version of the guideline document are maintained by the AE Working Group (AE WG) in accordance with the "Maintenance of IMDRF AE Terminologies" (IMDRF/AE WG/N44)FINAL:2020).
  • The terminology is always open for Change Requests. The process is outlined in the figure below. The cutoff date for inclusion in the next release is 1 September. The Change Requests will then be reviewed by IMDRF, and the updated terminology and outcome of Change Requests will be published in March.
    1. Stakeholder organization submits change request form (cutoff date: 1 September). 2. IMDRF AE TM WG (adverse event terminology maintenance group) - Considers change and makes recommendation to MC using change log. 3. IMDRF Management Committee (MC) makes positive or negative decision and submits change log to IMDRF AETMG. 4. IMDRF website - updated Terminology and Change Log will be published in March.
  • Proposal of addition/modification/deletion of the terms must be submitted to AE WG by either National Competent Authorities or Stakeholder Organizations, using the Change Request form. No proposal from an individual will be accepted.
  • Please use the most recent Change Request form below:

Appendices A & B: Change Request Form and Change Log - XLSX (16kb)