Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Learning outcomes

• Understand the purpose of companion diagnostic (CDx) IVDs • Appreciate the personalised medicine context for CDx • Be able to summarise the key requirements of the IVDR for CDx • Understand the implications of the IVDR for developers of both personalised medicines and CDx • Gain insight into outstanding issues and challenges

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IVDR definition of a companion diagnostic (CDx)

‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product;

The Organisation for Professionals in Regulatory Affairs

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