Guidance

Borderlines with medical devices and other products in Great Britain

Guidance on whether or not your product is a medical device.

Documents

Borderlines with medical devices and other products

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

This document gives help in working out if your product is considered to be a medical device under UK legislation.

Published 19 January 2015
Last updated 1 July 2023 + show all updates
  1. File 'updated in light of the extension of acceptance of CE marked devices on the GB market' updated in light of the extension of acceptance of CE marked devices on the GB market.

  2. Updates to 'Borderlines with medical devices and other products'.

  3. This has been updated due to the end of the Brexit transition period.

  4. First published.