Guidance

Off-label use of medical devices

How to comply with the regulations when using a medical device differently to the manufacturer's instructions.

• From: Medicines and Healthcare products Regulatory Agency
• 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.

Applies to England, Scotland and Wales

Documents

Off-label use of a medical device

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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.