Module 19 2021

24/05/2021

Questions? Comments?

Ben Jacoby, Cambridge RA Ltd.

bjacoby@cambridge-ra.com

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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 Co-ordination of Notified Bodies Medical Devices • NI Northern Ireland • PMPF Post-market performance follow-up • PSUR Periodic safety update report • SRN Single registration number • STED Summary technical documentation • UDI-DI Unique device identification – device identifier

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