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2 docs tagged with "borderline"

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Borderline & combination products

How MHRA approaches products that sit on the boundary between medical devices and other regulatory frameworks — medicines, cosmetics, biocides — and how drug-device combination products are regulated under the UK Medical Devices Regulations 2002.

What is not a medical device?

Products that are not medical devices under the UK Medical Devices Regulations 2002 — exclusions, borderline categories, lifestyle and wellness products, and how MHRA approaches products on the boundary of the definition.