Article 52 sets the conformity-assessment routes by class. Class I devices (other than sterile/measuring/reusable surgical instruments): self-declaration. Class I sterile / measuring / reusable surgical: limited NB involvement. Class IIa: NB review of technical documentation. Class IIb + Class III: full NB QMS + technical documentation assessment (Annex IX or X/XI). Class III implantables: Article 54 consultation procedure (clinical evaluation consultation) with expert panel. Certain Class IIb implantables: Article 54 procedure also applies. Article 55 establishes scrutiny mechanism for certain Class III/IIb conformity assessments by EU expert panels + MDCG.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.