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.26_27_28: Registration of devices and economic operators (Articles 26-28)

Article 26 requires registration of devices: before placing a device on the market or putting it into service, the manufacturer (other than custom-made or investigational devices) registers the device, the manufacturer and the UDI-DI in EUDAMED. Article 27 establishes the electronic registration system for economic operators. Article 28 requires manufacturers + authorised representatives + importers to register their data (identity + authorised activities + EU economic-operator identification number) in EUDAMED. The data is publicly accessible (with limited carve-outs for confidential information).

Other controls in IVDR - Identification + UDI + Registration + EUDAMED (Ch III)

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