The Medical Device Coordination Group (MDCG) has published MDCG 2022-5, Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
We highly recommend to carefully review the document if relevant. MDCG 2022-5 advises how to delineate between medical devices and medicinal products in scenarios where medicinal products, herbal products, substance-based medical devices and combination products are involved.
The document provides clarification, examples and flowcharts that are intended to establish a regulatory rationale for these complex products.
Please let us know should you require the guidance document. We will be happy to send.
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