Government regulatory agencies (such as the United States Food and Drug Administration (FDA), European Commission, and International Medical Device Regulatory Forum) have established Unique Device Identification (UDI) standards to identify and monitor the distribution and use of medical devices within healthcare environments
These UDI standards identify medical devices from manufacturing through distribution to patient use - enabling complete traceability of the millions of individual medical devices utilized for patient care. To enable UDI compliance, all medical devices must carry a UDI label to enable “track and trace” from the point of production, during shipment, through the product’s use and disposal.
