The Universal Device Identification (UDI) system was developed by the U.S, Food and Drug Administration (FDA) as global UDI compliance to protect patients and clinicians by improving traceability of medical devices through a common and shared system. It has and continues to fulfill its role in safety and traceability tenfold and medical device software has been added to the list of items requiring UDI.

Every UDI is entered in the FDA’s Global Unique Device Identification Database (GUDID), enabling the device to be tracked “should an adverse medical event occur, or a device fail.” While this system has been established for quite some time, it is only utilized in the United States. Europe has created a similar system, EUDAMED, but isn’t currently open to the public to reference. The goal is full implementation for EUDAMED by 2025. Any manufacturer planning to market their products in Europe is required to register in both the U.S. and European databases.

By fulfilling the regulatory requirements for both the EU’s Medical Device (MDR) regulation and the FDA’s UDI regulation, medical device manufacturers also benefit, since they can:

• Better manage recalls
• More easily distinguish between device versions, sizes, and other characteristics
• Track devices from different production facilities
• Collect accurate data for post-market surveillance
• Increase efficiency in their supply chain management.

The Pragmatyxs team stays up to date with all of the changes in compliance and regulations in the medical device industry and how they pertain to and impact labeling.