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
- Example - Specified design envelope
- Production processes that can be validated and/or verified, and reproduced
- Low volume supply of patient-matched medical devices
- More information
- Example - Patient-matched medical device
- Counter example
- Adaptable medical devices
- Overview
- Information to be supplied with an adaptable medical device
- Example - Adaptable medical device
- Counter example - not a manufacturer
- Counter example - not an adaptable medical device
- Custom-made medical devices
- Overview
- Custom-made or patient-matched?
- Example - Custom-made medical device for a patient
- Example - Custom-made medical device for a health professional
- Counter example - not a custom-made medical device
- Medical device production systems (MDPS)
- Overview
- Users of MDPS
- Example - Medical Device Production System (MDPS)
- Example – Using an MDPS to produce a device other than intended
- Counter example – A production system that is not an MDPS
- Who is a health professional or a suitably qualified person within a healthcare facility?
- Manufacturers and sponsors of an MDPS
- Example - Medical device production system (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
Supporting documents
Personalised medical devices (including 3D-printed devices)
[PDF, 579.19 KB]
Personalised medical devices (including 3D-printed devices)
[Word, 606.81 KB]
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