Module 16 2022

9/2/2022

Legacy Devices and MDR Article 120 Transitional Provisions

Stephan Buttron, Buttron Consulting Berlin, Germany

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Agenda

• MDR Regulatory Framework, Requirements and Key Changes • Article 120 Transitional Provisions • MDR Transition Timelines • Important Definitions • Overview of MDR regulations for legacy devices • Eudamed and legacy devices Registration • Bottlenecks and Business Risks • Interactive Case Study • Summary and Learning Outcome • Q&A

TOPICS

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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