Custom-made medical devices in Great Britain

How to comply with the regulatory requirements for manufacturing custom-made medical devices.


Examples of statements for custom-made medical devices

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Guidance for manufacturers on how to comply with the legal requirements for custom-made active implantable medical devices and custom-made medical devices. Information also explains what a custom-made device is and gives examples.

Published 16 August 2013
Last updated 31 December 2020 + show all updates
  1. This has been updated due to the end of the Brexit transition period.

  2. First published.