Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Masterclass

Risk Based Classification

Nancy Consterdine, Director IVDeology Ltd

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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Annex List II IVDs (high risk)

20% of IVDs Notified Body Interaction Required

Annex List I IVDs

Self-test general device

80% of IVDs Self-Declaration for CE marking

General In vitro diagnostics (low risk)

The Organisation for Professionals in Regulatory Affairs

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