Module 16 2024

17/10/2024

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

27

Questions?

The Organisation for Professionals in Regulatory Affairs

28

14