Guidance

Custom-made medical devices in Great Britain

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

Documents

Examples of statements for custom-made medical devices

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

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.