Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

1. The IVDR

2. Companion Diagnostics

Richard Bassett DLRC

The Organisation for Professionals in Regulatory Affairs

December 2023

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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 Clinical Trials for medicinal products ● Companion Diagnostics – what, when, and how they are used Learning Outcomes

The Organisation for Professionals in Regulatory Affairs

2

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