Unique Device Identification (UDI) made easy

Patient safety is the top priority in medical technology. Clear and consistent medical-device labeling is fundamental to this - from manufacturers to retailers and from hospitals to the patient. This maintains full transparency along the supply chain. Unique Device Identification enables those responsible for procurement and materials management to access regulatory specifications held in central databases. Serial numbers and expiration dates are examples of this. When a medical device is marked "UDI-compliant", no further details are required. In the foreseeable future, all medical devices in any risk class will require clear and machine-readable labeling.

All medical devices intended for sale in the United States or on the European market must have a UDI code. The goal is clear: a globally standardized UDI system. The medical technology industry in every market is being advised to label their products with UDI codes in anticipation of new legal requirements.

UDI labeling of medical devices is based on specific standards. To this end, the US Food and Drug Administration (FDA) has accredited three organizations as UDI issuing agencies: GS1, Health Industry Business Communications Council (HIBCC), and the International Council for Commonality in Blood Banking Automation (ICCBBA). Generally labels always consist of two parts: the "DI" (Device Identifier) and the "PI" (Production Identifier). The DI, which is identical for each item, includes the ID of the manufacturer or labeler as well as the reference code of the product. In contrast, the PI is dynamic, containing information such as expiration and manufacturing dates and serial numbers. The global data exchange network Global Unique Device Identification Database (GUDID) enables manufacturers to forward product information to the American FDA UDI database.

In contrast to the US FDA regulation, the EU introduced a new identifier based on the European Union Medical Device Regulation (EU MDR) – "Basic UDI-DI". This enables medical devices with similar characteristics to be grouped in the EU approval database EUDAMED. The device can only be submitted to the authorities responsible for approval after the medical device manufacturer or an authorized representative has allocated the new identifier.

All information on US regulations is available on the website of the US authority, the US FDA.

All key European regulations are summarized on the EU MDR website.