The accreditation certificate should name only main technical areas and technical areas taken from the Annex 1 tables (non-active, active non-implantable, active implantable and in vitro diagnostic devices, sterilisation methods, devices incorporating specific substances or technologies, and parts and services). Where a certification body seeks a technical area outside the tables, or one described as other than specified, it gives the accreditation body a detailed description with a list of the medical devices, their risk classification determined from an appropriate regulatory source (GHTF/SG1/N77, the European classification rules or national regulations) and a concise statement of intended purpose; the other-than-specified area is used only when no other category fits. Tables 1.1 to 1.6 apply to finished devices; parts, components, subassemblies, calibration, distribution, maintenance, transport and other services are scoped under Table 1.7, and where such parts or services plainly exist to support medical devices, or a contract manufacturer makes nearly complete devices, the certification body also needs accreditation in the relevant Tables 1.1 to 1.6 areas; calibration providers should hold ISO/IEC 17025 accreditation. Treating particular goods or services as medical devices is supported by official regulatory guidelines.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.