Article 56 requires manufacturers to plan + conduct + document a performance evaluation per Annex XIII covering scientific validity + analytical performance + clinical performance, and to update it throughout the device lifecycle (including via post-market performance follow-up, PMPF). Article 57 sets the general requirements for performance studies (informed consent + ethics committee approval + insurance + data integrity). Article 58 sets additional requirements for certain performance studies (interventional clinical performance studies involving surgical procedures, etc.) including authorisation by the Member State competent authority; coordinated assessment for multi-country studies.
This control maps to 4 controls across 3 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 4 it maps to, and the evidence behind each claim, over MCP and REST.