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Unique Device Identification (UDI)

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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. 


EU UDI BUTTON       FDA UDI Button    

IMDRF UDI       UDI Training Button


Medical Devices

Unique Device Identification (UDI)

The Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain.

 
GS1 designated as Issuing Entity for UDI in EU

GS1 designated as Issuing Entity for Unique Device Identification (UDI) by the European Commission (07 June 2019)

 
GS1 UDI Training and Advice

Advice and training from GS1 experts on implementing GS1 identification standards such as GTINs and barcodes for compliance with UDI requirements.

 
Preparing for UDI Implementation

The United States Food and Drug Administration (FDA), the European Commission and other regulators have made patient safety a strategic priority by developing legislation for Unique Device Identification (UDI). This short GS1 guide on Unique Device Identification for Medical Devices explains what UDI is and how it relates to existing GS1 standards for item identification.

 
Overview of UDI Requirements Leaflet

The GS1 System of Standards supports all stakeholders to efficiently and effectively meet UDI requirements by enabling interoperability within an organisation, between organisations and across borders. A single standard can ultimately accelerate implementation and increase compliance to the UDI regulations. This leaflet outlines UDI requirements in GS1 terms including product identification, barcode symbols and electronic data sharing.

 
Medical Device UDI Data Sharing with GS1 GDSN

A short introductory guide to Medical Device UDI Data Sharing with GS1 Data Synchronisation Standards and the GDSN

 
Compliance Dates for FDA UDI Requirements

The table below outlines key compliance dates in the UDI final rule.

 
GS1 accredited as issuing agency for UDI by FDA

Based on the UDI rule released in September 2013, the U.S. Food and Drug Administration (FDA) has officially accredited GS1® as a Unique Device Identifier (UDI) issuing agency. (Brussels, Belgium, 17 December 2013).

 
Unique Device Identification Whitepaper

Unique Device Identification 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.