International Medical Device Regulators Forum
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Open consultations
IMDRF Consultation Feedback - GRRP WG - N52 - Principles of Labeling for Medical Devices (Edition 3)
The purpose of this IMDRF guidance is to provide globally harmonized labeling principles for medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). Specifically, this document provides guidance on the content of the label, instructions for use (IFU), and information intended for the patient in order to support the safe and effective use of medical devices by their intended users. It also includes...
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). ...
IMDRF Consultation Feedback - CE IVD WG - Definitions and Principles of Performance Evaluation
This document supersedes earlier documents produced under the Global Harmonization Task Force (GHTF): GHTF/SG5/N6:2012 Clinical Evidence for IVD medical devices – Key Definitions and Concepts and...
IMDRF Survey - Use of IMDRF/MDSAP WG/N24 (Medical Device Regulatory Audit Reports)
The International Medical Device Regulators Forum (IMDRF) publishes documents to support global medical device regulatory harmonization and convergence. IMDRF is seeking feedback...