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Preparing for UDI Implementation

Are you ready?

Introduction to Unique Device Identification

GS1 UDI Brochure ThumbnailThe 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). UDI 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.

Benefits of UDI

The implementation of UDI can enhance patient safety and improve efficiency in the healthcare supply chain. The system is expected to unambiguously identify medical devices throughout the global supply chain allowing for more accurate reports of adverse events, more effective management of medical device recalls and reduction of medical errors by providing precise information for healthcare professionals, thereby providing a secure global supply chain.

Why not join our monthly Introduction to UDI Webinarto learn more?

GS1 Ireland UDI Webinar DetailsGS1 Standards for 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

Unique Device Identification = UDIGS1 Standards =
Product Identification
DI
Device Identifier (DI)
GTIN
Global Trade Item Number (GTIN)
PI Production Identifier (PI)
(if applicable)
AI
Application Identifier (AI)
- Expiration Date AI(17) - e.g. 141120
- Lot/Batch AI(10) - e.g. 1234AB
- Serial Number AI(21) - e.g. 12345XYZ
DI + PI = UDIGTIN or GTIN + AI(s) = UDI


 

Medical Devices

Calendar_100pxFirst UDI deadline is fast approaching

The U.S. FDA Unique Identification rule requires all medical devices sold in the U.S. to be identified and marked, and product information to be stored in the FDA database. The first deadline for class III (high risk) medical devices is 24 September 2014.

 
GS1 UDI Training and Advice

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

 
GDSN, UDI and GUDID Brochure ImageMedical 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.

 
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.

 
GS1 UDI Brochure Cover ImagePreparing 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.

 
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).

 
EU releases draft of new Medical Devices Regulation

On the 26th of September, the European Commission published its proposal for a revised regulatory framework for medical devices. The European Commission is also working on a Recommendation to the EU Member States on UDI in order to avoid the development of non-harmonised national UDI systems.

 
EU Commission on UDI

IMDRF Chairman, Laurent Selles from the EU Commission on the IMDRF's (International Medical Device Regulatory Forum) work to harmonise the regulation of medical devices.

 
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