Module 19: Regulation of In Vitro Diagnostic Medical Devices

18/04/2023

UK MDR 2002 transposed from EU IVDD • Use of CE marking either under IVDD, IVDR • Devices must be registered by 01 Jan 2021 • UKRP for non-UK manufacturers UKCA comes into force 01 July 2023 • All devices be UKCA marked for UK market • CE no longer accepted • Higher risk devices may need CA bodies to complete conformity assessment

Regulation to be published (Q1 2023?) • Similar to EU IVDR

The Organisation for Professionals in Regulatory Affairs

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Transition Timelines

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