Guidance
Borderline products: medical devices and medicinal products
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Applies to England, Scotland and Wales
Documents
Details
This guidance outlines how the MHRA decides whether a borderline product is a medical devices or a medicine, and which regulations apply.
This guidance is specific to products placed on the market in Great Britain (England, Wales and Scotland). Find out how medical devices are regulated in Northern Ireland.
Updates to this page
Published 19 January 2015
Last updated 31 December 2020
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Updated due to the end of the Brexit transition period.
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First published.