Article 11 requires a non-EU manufacturer to designate, by written mandate, a single authorised representative established in the Union, with Article 11(3) tasks. Article 12 governs orderly change of AR. Article 13 sets importer obligations: verify CE marking + EU DoC + manufacturer identification + AR appointment (non-EU) + device registration + labelling compliance. Article 14 sets distributor obligations: due care + verify CE marking + cooperate with manufacturer + report serious incidents.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.