According to the International Medical Device Regulators Forum (IMDRF), a Unique Device Identification (UDI) system is intended to provide a single, globally harmonised system for positive identification of medical devices through distribution and use.

2017年3月24日 · Unique Device Identification (UDI) improves patient safety and healthcare business processes and will require significant implementation investments by manufacturers, providers and other healthcare organisations.

Learn what a Medical UDI (Unique Device Identifier) is and how GS1 Standards can be used to support UDI implementation for all classes of medical devices.

GS1 is a U.S. FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule. This implementation guideline was prepared by GS1 Healthcare US® to assist suppliers and receivers of medical devices in the U.S. to implement the U.S. FDA UDI Rule using GS1 Standards.

The GS1 system of standards provides a global framework to identify, capture and share Healthcare product information, thereby enabling a consistent worldwide implementation of UDI. UDI regulatory requirements have a translation into GS1 standards as shown in the table.

There should be a Unique Device Identification at every level of packaging except at the logistic unit level. When possible, barcodes are to be displayed on the product packages to allow ready access to scanning equipment when the product is stored or stocked on shelves.

The GS1 UDI barcode combines the Device Identifier (DI), also known as the GTIN by GS1.org, and the Production Identifier (PI).

to assist U.S. medical device trading partners implementing the U.S. FDA UDI Rule using GS1 Standards. To that end, this document provides detailed guidance on how to apply GS1 Standards for U.S. FDA UDI.

GS1 US Data Hub | Product enables you to assign Device Identifiers (DI) using Global Trade Item Numbers (GTINs) for your Primary Device and Higher Levels of Packaging . UDI Production Identifiers (PI) are represented by GS1 Application Identifiers (AIs).

2024年11月13日 · Learn about UDI (Unique Device Identifier) and its importance in the medical device industry. Discover how UDI improves traceability, safety, and compliance, and how GS1 UK supports UDI implementation.