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Personalised medical devices (including 3D-printed devices)

Regulatory changes for custom-made medical devices
23 August 2021
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This document provides information and examples to help you understand the Framework and meet your regulatory obligations. The intention of the examples is not to tell you how every device is regulated, but to provide enough information to help you identify the concepts and boundaries in the Framework so you can apply these concepts to your own circumstances.

  • Background and overview
    • Other resources
  • Patient-matched medical devices
    • Overview
    • Specified design envelope
    • Production processes that can be validated and/or verified, and reproduced
    • More information
  • Adaptable medical devices
    • Overview
    • Information to be supplied with an adaptable medical device
  • Custom-made medical devices
    • Overview
    • Custom-made or patient-matched?
  • Medical Device Production Systems (MDPS)
    • Overview
    • Users of MDPS
    • Who is a health professional or a suitably qualified person within a healthcare facility?
    • Manufacturers and sponsors of an MDPS
    • Information to be supplied with an MDPS
    • What you need to do
  • Appendix 1: Personalised medical devices decision tree
  • Appendix 2: Statement template for custom-made medical devices

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