Article 70 sets the application procedure for clinical investigations through EUDAMED + Member State competent authority. Article 74 covers clinical investigations on CE-marked devices used outside the intended purpose. Article 75 covers substantial modifications to clinical investigations. Article 80 sets recording + reporting of adverse events: investigators record + report adverse events to the sponsor; the sponsor reports serious adverse events (SAEs) and serious adverse device effects (SADEs) to Member State competent authorities + Member States cooperate to evaluate the safety profile. Article 82 covers ethics committee involvement.
This control maps to 1 controls across 1 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 1 it maps to, and the evidence behind each claim, over MCP and REST.