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Home » IMDRF Issues Final Guidance on UDI, Software as a Medical Device
IMDRF Issues Final Guidance on UDI, Software as a Medical Device
Devicemakers must include all of the core data elements for the Unique Device Identification Database except those marked “optional,” according to a harmonized guidance on UDI. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, the International Medical Device Regulators Forum says.
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