IMDRF Consultation Feedback - Essential Principles and Content of PCCP (N90 - SaMD WG)

Overview

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 will be provided the option to download a change form which can be submitted as an attachment once completed.

Why your views matter

The SaMD Working Group appreciates your feedback which will be considered prior to finalization of the document for publication.