Article 8 provides that IVDs in conformity with relevant harmonised standards (references published in the OJ) are presumed in conformity with the requirements of the Regulation covered by those standards. Article 9 enables the Commission, where no harmonised standards exist or are insufficient, to adopt common specifications (CS) for performance and safety requirements; conformity with CS gives presumption of conformity equivalent to harmonised standards.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.