Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Learning Outcomes: Recap

 Introduce the other Directives and Regulations which impact IVD design and development ● Looked at 10 other directives and regulations  Understand what the Directive/Regulation is there to govern ● They impact either safety, sustainability or security around the device ● Some have their own CE mark e.g. RoHS  Understand how and where these fit with the IVD Regulation ● All have an impact to the design and development of IVD products

The Organisation for Professionals in Regulatory Affairs

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Acknowledgements

Stuart Angell, IVDeology Ltd

The Organisation for Professionals in Regulatory Affairs

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