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
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). The IMDRF Software as a Medical Device (SaMD) Working Group seeks your feedback on the draft document through this consultation which is open until 8 December 2025. This online feedback form is designed for a maximum of 10 proposed changes. Should you wish to suggest more than 10 changes you...
Closed consultations and engagement
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...