A device must do what the manufacturer says it does, and its design, production and packaging must make it fit for one or more of the purposes that make a product a medical device under section 41BD(1) of the Act (diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, investigation or modification of anatomy or a physiological process, control of conception and the like). Performance claims in the intended purpose and labelling are therefore tested against verification and clinical data.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.