Under Part 6 (used alone for most Class I and Class 1 IVD devices and with other procedures for Class IIa and Class 2 IVD devices) the manufacturer must prepare technical documentation that would allow the Secretary, if it chose, to judge compliance with the essential principles, classification rules and procedures, and must have available its name and address, manufacturing sites, device identification and an undertaking to pass on serious incident and recall information. The documentation must include a general description and variants, design drawings and explanations, the sterilisation method if supplied sterile, the standards applied and the solutions used where they were not, design calculations, risk analyses and test results, connection evidence for devices that join others, the clinical evidence and the information to be supplied with the device. It must be revised whenever design or production changes, for example after a corrective action.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.