Medical Device UDI Data Sharing with GS1 GDSN
A short introductory guide to Medical Device and Unique Device Identification (UDI) Data Sharing with GS1 Data Synchronisation Standards and the GDSN.
How Global Data Synchronisation enables Unique Device Identification (UDI)
Unique Device Identification or UDI for medical devices is expected to improve patient safety and healthcare business processes. 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 the lack of 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, such as the FDA GUDID, and the benefits Global Data Synchronisation brings to the community.