The purpose of this IMDRF guidance is to provide globally harmonized labeling principles for medical devices and IVD medical devices and support the IMDRF Essential Principles of Safety and Performance. Specifically, this document provides guidance on the content of the label and instructions for use in order to support the correct, safe, and effective use of medical devices and IVD medical devices by their users.
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Principles of Labeling for Medical Devices and IVD Medical Devices