Module 16 2024

17/10/2024

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

Databases

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• Regulatory Databases / GDSN

• US FDA GUDID

• EUDAMED

Traceability

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• How UDI enhances supply chain traceability through to use on a patient.

The Organisation for Professionals in Regulatory Affairs

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