Module 16 2022

05/09/2022

Unique Device Identification & Traceability in Healthcare

Jenny Young-Gough

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Outcomes

• Unique Device Identification (UDI) • Understanding what UDI is and how it is applied? • Basic UDI-DI • EUDAMED and databases • What is Eudamed and what is its purpose. • Other Databases – Regulatory / GDSN • Traceability • How UDI enhances supply chain traceability through to use on a patient. • What is the role of EUDAMED from a traceability perspective

The Organisation for Professionals in Regulatory Affairs

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