Scenario 1: Healthcare facility using MDPS | Scenario 2: Traditional Manufacturer Co-location | Scenario 3: HCF assumes all manufacturer responsibilities | |
---|---|---|---|
Entity designing/ developing the device | Traditional Manufacturer | Traditional Manufacturer | Healthcare Facility |
Entity using the 3D printing system to produce devices | Healthcare Facility | Traditional Manufacturer, including any potential Contract Manufacturer | Healthcare Facility |
Entity responsible for complying with applicable regulatory requirements | Traditional Manufacturer | Traditional Manufacturer, including any potential Contract Manufacturer | Healthcare Facility |