New guidance on borderline products between drugs and medical devices under the MDR

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.

Source: MDCG

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