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Guidance: Medical devices: off-label use

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Medicines Healthcare Products Regulatory Agency
May 17
12:14 2023
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Off-label use of a medical device

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Its 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 17 May 2023 +show all updates

  1. 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.

  2. First published.

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