Adverse Events Terminology - Change Request Form

Overview

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 - 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

IMDRF 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).
• 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.

This form

Please use this form to propose changes.

To propose changes, download the template Excel sheet, and add requested information. Upload the Excel sheet including information on proposed changes using the ‘Choose File’ button. If you wish to attach multiple documents to your submission, please upload through a 'Zip Folder' instead.