• Armağan

Principles of Labelling for Medical Devices and IVD Medical Devices

21 March 2019

The purpose of this IMDRF guidance is to provide globally harmonized labelling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support the IMDRF Essential Principles o f Safety and Performance'. Specifically, this document provides guidance on the content of the label, instructions for use, and information intended for the patient in order to support the safe and effective use of medical devices and IVD medical devices by their intended users.