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Personalised medical devices (including 3D-printed devices)

Regulatory changes for custom-made medical devices
21 June 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 information to help you identify the boundaries of concepts in the Framework so you can apply these concepts to your own circumstances.

  • Background and overview
  • 1. New definitions for personalised medical devices
    • 1.1 Patient-matched medical devices
    • 1.2 Adaptable medical devices
    • 1.3 Custom-made medical devices
    • 1.4 Medical Device Production Systems (MDPS)
  • 2. Custom-made medical devices
    • Overview
    • Does classification rule 5.4 apply to my device?
    • 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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