The certification body uses the technical areas in the Annex A 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) to help define the scope of certification, to identify whether technical qualification including sterilisation competence is needed for a technical area, and to select a suitably qualified team. Technical areas outside the tables are detailed; for areas described as other than specified the body gives the accreditation body a list of devices with risk classification (European classification rules, GHTF/SG1/N77 or national rules such as the FDA's) and a concise intended purpose, using that category only when no other fits. Parts and associated activities not categorised as finished devices are scoped under Table A.1.7, supported by regulatory guidance; where parts or services plainly exist to support devices, or a contract manufacturer makes nearly complete devices, the body also holds the relevant Tables A.1.1 to A.1.6 scope, and calibration providers should hold ISO/IEC 17025 accreditation.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.