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UDI in Europe and EUDAMED


UDI in Europe and EUDAMED

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Where am I - content-blog-article.php

In 2013, the European Commission recommended working toward a harmonized European standard for a unique device identification (UDI) system for medical devices. Since then, regulators and industry have been working toward a final directive on the system to provide identification and traceability of medical devices across the 28 member countries of the European Union. That […]

UDI in Europe: What Will Be Different?

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Where am I - content-blog-article.php

As the United States expands the scope of the FDA Unique Device Identification (UDI) system to include additional medical devices classes, other countries are moving forward to create similar UDI systems to better identify medical devices from the manufacturer, through the supply chain, to the patient. The International Medical Device Regulators Forum (IMDRF), the European […]