Guidance

Borderlines between medical devices and medicinal products

How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.

Documents

Borderlines between medical devices and medicinal products

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Details

This document sets out, in broad terms, the regulation of specific products and distinguishes between products which are regulated as medical devices and those which are regulated as medicinal products.

While there are other ‘borderlines’ with medical devices (for example with cosmetics, personal protective equipment, biocides etc) this guidance focuses on the difference between medical devices and medicinal products.

Published 19 January 2015