Module 18 2021

06/02/2021

1. The IVDR and 2. Companion Diagnostics

Volker Franzen / Maranna Sweeney

The Organisation for Professionals in Regulatory Affairs

February 2021

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Learning Outcomes

To understand and describe: ● The definition of an IVD ● The current issues with implementation of the IVDR ● Classification of IVDs under IVDR ● Where they might be used in association with DDCs ● Companion Diagnostics – what, when, and how they are used.

The Organisation for Professionals in Regulatory Affairs

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