Module 19 2021

01/06/2021

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

25

Acknowledgements

Gill Morgan, Sestria Ltd Stuart Angell, IVDeology Ltd

26

13