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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 19 January 2015
• Last updated: 31 December 2020 — See all updates

Documents

Borderlines between medical devices and medicinal products

PDF, 308 KB, 14 pages

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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

Last updated 31 December 2020 + show all updates

1. 31 December 2020

   Updated due to the end of the Brexit transition period.

2. 19 January 2015

   First published.