IMDRF Consultation Feedback - CE IVD WG - Definitions and Principles of Performance Evaluation

Overview

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 GHTF/SG5/N7:2012 Clinical Evidence for medical devices – Scientific Validity Determination and Performance Evaluation.

It outlines the concepts, principles and terminology for clinical evidence related to in vitro diagnostic (IVD) medical devices, taking into account the differences between IVD medical devices and other medical devices.

This online form is designed for a maximum of 10 proposed changes. Should you prefer, or have 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 IMDRF Clinical Evidence for In Vitro Diagnostic Medical Devices Working Group appreciates your feedback which will be considered prior to finalization of the document for publication.