Unique Device Identification (UDI)

On September 24, 2013, the U.S. Food and Drug Administration (FDA) released its final rule requiring device labelers to include a unique device identifier (UDI) on most medical devices distributed in the United States.1 The goal of the UDI system is to improve product safety by identifying a product throughout its journey from the manufacturing floor to its use at a patient’s bedside. UDI also facilitates better supply chain tracking and efficiency. In the last few years, other countries, regulatory groups, Global Purchasing Organizations (GPOs), and Integrated Delivery Networks (IDNs) established similar UDI requirements – setting the standards for accurate product data on device packaging and in electronic systems.2


Global UDI Compliance


Although there are differences among global UDI rules, they typically include three components:

UDI-Compliant Label

The UDI itself is a unique number assigned to the version or model of a device. It is required on all medical devices package labels, and includes both the Device Identifier (DI) and the Production Identifier (PI):

1. DI – a required, fixed number that identifies the labeler and specific version of the device.
2. PI – a variable portion of the UDI that may include the product’s lot or batch number, expiration date and manufacturing date.

Direct Part Mark

A direct part mark is a permanent UDI marking on the device itself. If a device will be used more than once, on more than one patient, and reprocessed before each use, it must be direct part marked. This allows accurate identification when the device is no longer accompanied by its label or package.


Electronic Product Data

Most global UDI rules also require device labelers to make electronic product data available to their customers. The United States mandates data publication to the Global Unique Device Identification Database (AccessGUDID), a publicly searchable database administered by the FDA that serves as a reference catalog for each device with a UDI. The United Kingdom’s National Health Service (NHS) established eProcurment/Scan4Safety, that requires product data be available to customers via the Global Data Synchronization Network (GDSN).3 Additionally, the European Union is in the process of establishing EUDAMED, an EU medical device database for product data.4 Participation in this database is required in 2020 by the EU Medical Device Regulation (MDR).


UDI Compliance Timelines

The FDA, NHS, and EU MDR use phased approaches to compliance depending on the device's risk classification. Use the links below to access additional UDI resources electronically.

 


References

1. Unique Device Identification System. Federal Register Web site. https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system#h-7
2. GS1 The Global Language of Business: Standards, Health Care Industry. GS1 Web site. https://www.gs1.org/
3. eProcurement. NHS Peninsula Purchasing and Supply Alliance Web site. https://www.ppsa.nhs.uk/eprocurement/
4. Regulation (EU) 2017/746 of the European Parliament and of the Council. EUR-Lex: Access to European Law Web site. https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1529686674951&uri=CELEX:32017R0746
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