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.
This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.