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Home » IMDRF Releases Final UDI Guidance, Requirements for Medtech Software
IMDRF Releases Final UDI Guidance, Requirements for Medtech Software
Medical device companies must include all core data elements for the unique device identification database except those marked “optional,” according to the International Medical Device Regulators Forum. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, IMDRF adds.