Every device must come with information identifying it and its manufacturer and explaining how to use it safely, pitched at the training of likely users. The information must be in English (other languages may be added), suit the device and purpose in format, content and location, have characters at least 1 mm high, and explain any symbol or identification colour not found in a medical device standard. It goes on the device itself unless that is impracticable, otherwise on the packaging (or outer packaging where individual packing is impracticable), and failing that on a leaflet, or for software on a leaflet or electronically. Clause 13.3 lists what must be given: manufacturer name or trading name and address; intended purpose, user and patient where not obvious; identification of the device or pack contents; handling and storage needs; warnings and precautions; special operating instructions; single-use, custom-made, clinical investigation or performance-evaluation-only indications where relevant; STERILE and the sterilisation method; batch, lot or serial number; a use-by month and year or else the date of manufacture; and for export only where applicable.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.