Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Masterclass

IVD Registration

18 – 20 April 2023

Nancy Consterdine, Director and Co-Founder, IVDeology LTD

IVDEOLOGY APP IVD Regulation tool Available to download now

www.ivdeology.co.uk info@ivdeology.co.uk

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Learning Objectives

• To understand The process for EU device registration including UKCA requirements • To examine the use of EUDAMED • Examine UDI requirements • To review the big 6 regulated markets requirements • To review other regulators and what they need

The Organisation for Professionals in Regulatory Affairs

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