Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Learning outcomes

• Understand the purpose of CDx IVDs • Appreciate the personalised medicine context for CDx • Gain high level knowledge of the IVDR requirements 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

The Organisation for Professionals in Regulatory Affairs

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Acknowledgements

Michael Messenger Principal Scientific Advisor – IVDs Devices - Safety & Surveillance, MHRA

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