International Medical Device Regulators Forum
Take part in consultations, surveys and conversations that interest you, find out more about decisions we've made and complete membership applications.
Open consultations
Adverse Events Terminology - Change Request Form
The IMDRF Adverse Event Terminology is always open for Change Requests. The cut-off date for inclusion in the next release is 1 September. The Change Requests will then be reviewed by the AET 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...
Closed consultations and engagement
IMDRF Consultation Feedback - Essential Principles and Content of PCCP (N90 - SaMD WG)
This document serves to facilitate international convergence and harmonize approaches across 90 jurisdictions by describing essential principles for Predetermined Change Control Plans (PCCPs). ...