EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - Identification + UDI + Registration + EUDAMED (Ch III)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.22_23_24_25: Identification within supply chain + UDI system (Articles 22-25)

Article 22 requires economic operators to identify, on request of competent authorities, any other economic operator that supplied them with a device + to whom they have supplied a device, for 10 years. Article 23 references the medical devices nomenclature (the EU's harmonised vocabulary). Article 24 establishes the Unique Device Identification (UDI) system: every IVD (except custom-made + investigational) carries a UDI consisting of a UDI-DI (device identifier) + UDI-PI (production identifier where relevant); class-A devices have a UDI on the packaging only. Article 25 governs the central UDI database within EUDAMED.

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