Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745

Check the final guidance from the MDCG. This document provides further explanations and examples clarifying these provisions in order to support the uniform application of the MDR across the EU. The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.

Find it attached!

MDCG 2022 – 5

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