Article 4 imposes specific requirements for IVDs intended for use as genetic tests on individuals. Member States ensure that the use of a genetic test is accompanied by appropriate information about the nature, the significance and the implications of the genetic test, including counselling where appropriate, and informed consent. Article 4 explicitly recognises the GDPR applies to the processing of genetic data; Article 4 supplements the GDPR with the medical-device dimension.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.