How Global Data Synchronisation enables Unique Device Identification (UDI)




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Unique Device Identification (UDI) for medical devices is expected to improve patient safety and healthcare business processes. A single, global system of standards is fundamental to enable an efficient and effective implementation of UDI by all healthcare stakeholders worldwide. Major regulators working together via the International Medical Device regulators Forum (IMDRF) have made safety and integrity of the global supply chain a strategic priority.

The regulatory requirements for UDI propose to address today’s supply chain and patient safety issues involving identification of medical devices, inefficient and ineffective product recalls, incomplete adverse event reporting, and inefficient hospital supply chain processes.

One of the most challenging areas related to the implementation of the UDI regulation is Master Data Management. This brochure highlights several areas which a manufacturer should consider when preparing their product data for registration in a UDI database, and the benefits Global Data Synchronisation brings to the community.

By GS1 Healthcare

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