Unique Device Identification (UDI)
Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain.
The IMDRF (International Medical Device Regulator Forum), the United States Food and Drug Administration (FDA) and the European Commission are aiming for a globally harmonised and consistent approach to increase patient safety and help optimise patient care by proposing a harmonised legislation for Unique Device Identification (UDI), using global standards.
Advantages of GS1 standards for the implementation of UDI
The GS1 system of standards supports all stakeholders to efficiently and effectively meet UDI requirements by enabling interoperability and compatibility within an organisation, between organisations and across borders.
A single standard can ultimately accelerate implementation and increase compliance to the UDI regulations. GS1 has over 110 GS1 Member Organisations and more than 2,000 employees worldwide providing support to users on how to implement UDI in their local language and understanding the local requirements for implementation.
Unique Device Identification in GS1 Terms
GS1 is a FDA accredited and EU designated issuing authority. See links below for how GS1 Standards can be implemented for specific regulations.