Article 25 requires economic operators to identify, on request of MSA, any other economic operator that supplied them with the device or to whom they have supplied the device, for 10 years (15 years for implantable devices). Article 27 establishes the UDI system: every MD (except custom-made + investigational) carries a UDI consisting of UDI-DI + UDI-PI; Class III + implantable devices have full UDI on the device itself + packaging. Article 28 governs the UDI database within EUDAMED.
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.