Guidance
Off-label use of medical devices
How to comply with the regulations when using a medical device differently to the manufacturer's instructions.
Applies to England, Scotland and Wales
Documents
Details
This guidance explains what off-label use is and why it may happens. It also provides information on the regulations and risks of using medical devices in this way.
Updates to this page
Published 18 December 2014
Last updated 1 July 2023
show all updates
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This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
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Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
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First published.