Module 16 2022

05/09/2022

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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Why UDI – McKinsey ‘Strength in Unity’ Report

• UDI is an enabler – McKinsey Report (October 2012) highlighted the patient safety benefits and cost savings from adopting a single global supply chain standard in healthcare. • Could save 22,000 – 43,000 lives • Could avert 0.7 million to 1.4 million patient disabilities • Cost savings of $40 - $100 billion globally

The Organisation for Professionals in Regulatory Affairs

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