Article 1 establishes the scope: IVDs (including their accessories) placed on the Union market or put into service in the Union. Article 1(2) clarifies that IVDs incorporating tissues or cells of human origin or their derivatives, or substances which are administered to humans, are within scope. Article 2 supplies the definitions including 'in vitro diagnostic medical device', 'IVD intended for self-testing', 'companion diagnostic', 'genetic test', 'performance', 'risk class A/B/C/D', 'economic operator', 'manufacturer', 'authorised representative', 'importer', 'distributor', 'Person Responsible for Regulatory Compliance (PRRC)', 'EUDAMED', 'UDI'. Article 3 (regulatory status of products) governs cases where it is not clear whether an item is an IVD or a different category of product.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.