Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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Questions? Comments?

bjacoby@cambridge-ra.com Ben Jacoby, Cambridge RA Ltd.

The Organisation for Professionals in Regulatory Affairs

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Abbreviations

• CS Common specification • DoC Declaration of conformity • GB Great Britain • GHTF Global Harmonization Task Force • IMDRF International Medical Device Regulators Forum • IFU Instructions for use • IVD in vitro diagnostic medical device • IVDD

Directive 98/79/EC on in vitro diagnostic medical

devices • IVDR

Regulation (EU) 2017/746 on in vitro diagnostic medical devices

• MDCG Medical Devices Coordination Group • NB Notified body • NBMED Northern Ireland • PMPF Post-market performance follow-up • NI

Co-ordination of Notified Bodies Medical Devices

• PSUR Periodic safety update report • SRN Single registration number • STED Summary technical documentation • UDI-DI Unique device identification – device identifier

The Organisation for Professionals in Regulatory Affairs

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