Preparing for UDI Implementation
Are you ready?
Introduction to Unique Device Identification
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). 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 ourIntroduction to UDI Webinarto learn more?
GS1 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 = UDI||GS1 Standards =|
Device Identifier (DI)
Global Trade Item Number (GTIN)
|PI Production Identifier (PI)|
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 = UDI||GTIN or GTIN + AI(s) = UDI|
UDI and Product Data Sharing
UDI update - are you ready for 2017?
In the US the compliance date for Class 3 medical devices was September 2014. This means that if you are supplying product into the US, a condition of sale is that there is a UDI (standardised barcode with ID and batch information) on the product packaging. The compliance dates are staggered over the next few years to support implementation by suppliers.
A similar regulation is expected to take effect in 2017 for EU member states. If you would like to learn more about this we regularly host "Introduction to UDI" webinars. Details can be found on our Calendar of Healthcare Events.