Guidance

Medical devices: off-label use

What is considered off-label use of a medical device and examples of it.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 1 July 2023 — See all updates

Documents

Off-label use of a medical device

HTML

Details

It’s considered off-label use if you use a medical device differently to how the manufacturer has instructed. This includes changing a medical device to suit new needs.

Published 18 December 2014
Last updated 1 July 2023 + show all updates

1. 1 July 2023

   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.

2. 17 May 2023

   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.

3. 18 December 2014

   First published.