Overview of UDI Requirements Leaflet

UDI Requirements in GS1 terms including product identification, barcode symbols and electronic data sharing.

GS1 Ireland, March 2015


Leaflet: Overview of UDI Requirements in GS1 terms including product identification, barcode symbols and electronic data sharing.Introduction
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.

In December 2013, GS1 was accredited as an Issuing Agency by U.S. Food and Drug Administration (FDA) for Unique Device Identification (UDI) of Medical Devices to meet new patient safety, traceability and supply chain security regulations.

GS1 standards for UDI

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.

 

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

GUDID (Global UDI Database)

Data Elements linked to the DI (Device Identifier) element

GS1 Certified Datapool

Attributes (product data) mapped to each GUDID data element

There are different options for registering data in the US FDA Global UDI Database (GUDID). GS1 certified data pools (called the NPC in Ireland) can register data on behalf of the manufacturers using the HL7 Structured Product Labeling (SPL) standard. A key benefit is that information uploaded to the NPC can be shared with many locations and entities such as the FDA, EU and Healthcare providers).

Three elements of UDI diagram

Note: It is expected that the EU requirements for UDI will be similar to those of the FDA with a compliance date of 2017 (a phased approach based on risk class of medical device).

Download a copy of the diagram:

Overview of UDI Requirements