The Medical Devices Introductory Course 2020

IVD Overview and the IVDR

Simon Richards VP, Div Regulatory Affairs Abbott Rapid Diagnostics Ltd.

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

Learning Outcomes

• Welcome • What are IVD’s and a short history • EU definitions of IVD’s • IVDR and MDR similar but different 90 mins

The Organisation for Professionals in Regulatory Affairs