International – Final Document- Principles of Labelling for Medical Devices and IVD Medical Devices

The purpose of this IMDRF guidance is to provide 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). 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…