Skip to main content

The IMDRF have published a new guidance document “Principles of Labeling for Medical Devices and IVD Medical Devices” (IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)). This document provides a globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). This document also 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.