UDI regulations and systems in different parts of the globe are in different evolving stages. Yet, they all have one thing in common: the critical need for unique device identification when advancing patient safety.

In existence for a few months to multiple years, UDI regulations and systems in Europe, the United States and Turkey represent are examples of ongoing efforts to make UDI ubiquitous worldwide.

The European Union Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) was adopted in May 2017 to define the requirements for the UDI system in Europe. Salvatore Scalzo, Policy and Legal Officer with the European Commission, advised that GS1 is, until further decision, one of the designated issuing entities listed in the regulation and manufacturers are expected to use a designated issuing entity to implement the new system. He provided an overview of the regulation’s scope, milestones and projected outcomes for a harmonised framework throughout Europe to enhance quality of care, patient safety and business processes.
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In the U.S., the FDA’s UDI regulation is now been implemented for four years with UDI labelling of Class III, II and implantable devices completed. Approximately 1.5 million UDI records reside in the GUDID (US FDA UDI database); 80% of them are using GS1 standards. Terrie Reed, Senior Advisor for UDI Adoption at the FDA, stressed how UDI data is being used by healthcare providers for real-life benefits.
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Dr. Yalçin Soysal, Head of the Department of Medical Devices Registration and Coordination, Ministry of Health in Turkey, reported the system now has more than 6 million medical devices registered. Following the PIP breast implant recall, ÜTS, a national infrastructure to track products has been created to ensure devices traceability on the Turkish market, with plans to launch a mobile app for citizens’ use.
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