Article 5(1) prohibits placing on the market / putting into service of IVDs that do not comply with the Regulation; Article 5(5) sets the in-house IVD exception for healthcare institutions in narrow circumstances. Article 6 governs distance sales: IVDs offered through information-society services to natural or legal persons established in the Union must comply with the Regulation; offers must clearly state that the device complies with the Regulation. Article 7 prohibits misleading text/names/trademarks/picture/signs that may mislead the user/patient as to the device intended purpose, safety or performance.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.