MDCG Guidance on Borderline Between Medical Devices and Medicinal Products: Substance-Based Products
The new article further elaborates on the key matters associated with substance-based products intended to be marketed and used within the EU.
The new article further elaborates on the key matters associated with substance-based products intended to be marketed and used within the EU.
The new article describes in detail the regulatory status of herbal products.
The article outlines the key points related to the regulatory framework for borderline products.
The new article further describes the applicable regulatory considerations, paying additional attention to the key concepts used in the context of borderline products in order to ensure the relevant regulations are applied properly.
The document outlines the approach to be followed in order to ensure standardisation for medical devices, facilitating further harmonisation of the relevant regulatory requirements.
The new article describes in detail the relevant harmonised standards applicable to medical devices, and also the way they should be applied.
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