MDCG 2021-19

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custom made device, or a system or procedure pack on the market, the manufacturer or producer shall assign a Basic UDI-DI. For devices that are subject to a conformity ... and better traceability of such critical safety parts/components. 6 Annex I, Chapter III, section 23.2, point (s) MDR. 7 For example, national registries for implantable devices.

  Critical, Procedures, Part, Traceability