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
Patient-matched medical devices
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
Example - Patient-matched medical device
Adaptable medical devices
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
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)
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
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