Article 48 sets the conformity-assessment routes by class. Class A devices (other than self-tests/sterile/measuring): manufacturer self-declaration (Annex II + III technical documentation; no NB). Class A sterile, Class B, Class C, Class D: NB involvement required, with specific Annex IX (full QMS + tech doc assessment) / Annex X (type examination) / Annex XI (production-quality assurance) routes. Class C companion diagnostics require consultation with the EMA per Article 48(8). Article 49 details NB involvement. Article 50 establishes a mechanism for scrutiny of Class D conformity assessments by EU reference laboratories + the MDCG (additional safeguard for the highest-risk devices).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.