Whoever puts together a system or procedure pack must sign a declaration of conformity that cites clause 7.5, gives its name and address, identifies the pack and each item, states it has the conformity assessment document, clause 6.6 declaration or custom-made statement for each device that needs one and evidence that each device meets the essential principles, gives the registration, listing or biological number of each medicine or other therapeutic good, states each item is used within its intended purpose or approved indications and that mutual compatibility was verified against the manufacturers' instructions and indications and the pack was made accordingly, confirms each item's own instructions for use are included, covers any modification of a device or its packaging, states that manufacture, verification and packaging are under a documented internal control and inspection method, and for sterile packs that full QA or production QA was applied; it is signed, named and dated. A modification must not affect the device's quality, safety or performance, and if not done per the device manufacturer's instructions the assembler needs its own conformity evidence for the modified device. The assembler must run a post-marketing system with prompt notification to the Secretary and keep records for 5 years (15 for implantable devices).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.