Module 15 2022

19/05/2022

Lecture 7: Assessment of equivalence under the MDR: When and how can this be leveraged?

Paul Risborough

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Agenda

Key concepts of equivalence

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• The characteristics of equivalence • Specific cases: • Implantable and Class III • Non-implantable and non-Class III • How to present an equivalence assessment • Summary

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

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