The device must be designed, made and packed so that, when it is transported and stored in line with the manufacturer's instructions and information, its characteristics and performance during intended use are not adversely affected. Transport simulation and storage condition studies are the usual evidence, and the sponsor's own storage and transport duty under regulation 5.9 depends on these instructions being clear.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.