Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

Masterclass

Other Regulated Markets

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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The big regulated markets - USA  Class III devices are highest risk (Pre-Market Approval) and need full audit as well as file review.  Consensus standards are set such as ISO14971 and include CLSI for device performance criteria  Clinical Study in US  Instruments must meet 60601-1 (EU EMC/Safety OK) but are considered as Class I  Manufacturer must have a FDA Unified Registration and Listing System (FURLS) registration of site and products – annual payment for establishment registration $6493 for 2023  UDI Requirements for Class II and III products

 US agent required  Costs $5k-$250K  time 90 days to 2 years

The Organisation for Professionals in Regulatory Affairs

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