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Guidance on borderline products under MDR: MDCG 2022 - 5 published

The guideline MDCG 2022-5 has been published on 26th April 2022. The proper implementation of legislation on medical devices (pursuant to Regulation (EU) 2017/745 - MDR) and medicinal products for human use (pursuant to the Directive 2001/83/EC – MPD is crucial for correct interpretation and enforcement of these legislations.


Several provision to establish demarcation between these two types of product has already been included in the legal texts, but this guideline focuses on further explanations and practical examples.

Document contais 4 separate chapters: BORDERLINE PRODUCTS: MEDICAL DEVICES / MEDICINAL PRODUCTS, HERBAL PRODUCTS, SUBSTANCE-BASED MEDICAL DEVICES and MEDICAL DEVICE AND MEDICINAL PRODUCT COMBINATIONS, where you can find general principles and definitions and specific examples.


This guideline can be found on the website of the European Commission.

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