Medical Devices Update: New Guidelines for Medical Device Labeling!
The International Medical Device Regulators Forum (IMDRF) has released a new document outlining the principles of labeling for medical devices, including those for in-vitro diagnostics (IVDs).
This document aims to standardize the content and format of medical device labeling, which can be presented in paper or electronic form. It covers general labeling principles and includes specific sections on the label itself, instructions for use, and patient information.
It’s important to note that this document provides general guidelines and doesn’t cover everything. Manufacturers should also consider the requirements of any relevant medical device or IVD medical device-specific standards. Additionally, advertising and promotional materials are not included in the scope of this document, and individual regulatory authorities may have their own requirements for these elements.
This new guidance promotes clear and consistent labeling for medical devices worldwide, which can ultimately improve patient safety and device use.
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