Unique Device Identification Whitepaper

Global standards pave the way for Unique Device Identification (UDI)


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.

The United States Food and Drug Administration (FDA), the European Commission and other regulators have made safety and integrity of the global the Healthcare supply chain a strategic priority by proposing legislation for Unique Device Identification. The regulatory requirements for UDI, which are in development, propose to address today's supply chain and patient safety issues involving identification of medical devices, inefficient and ineffective product recalls, incomplete adverse event reporting, counterfeit products, and inefficient hospital supply chain processes.

The successful implementation of UDI by all Healthcare stakeholders from manufacturers to Healthcare providers will depend on several factors, including the following:

Global reach: Local deviations must be avoided and will have a negative impact on UDI.

Sector-wide reach: All stakeholders need to collaborate on the use of UDI to realise the full potential of UDI in the industry.

Risk-based approach: To be effective and inclusive, the diversity of medical devices must be considered.

Standards based approach: Leveraging open, global and user led standards will maximize efficiency and consistency in product data capture and reporting. Open standards, such as GS1, provide a scalable framework for global interoperability and future improvements.

The GS1 system of standards provides a global framework to identify, capture and share Healthcare product information, thereby enabling a consistent worldwide implementation of UDI.

An overview of the regulatory requirements and how they can be met through the utilisation of a single, global standard for identification, can be found in this GS1 UDI Whitepaper.