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SUMMARY:IVD Deep Dive Series Part 2
DESCRIPTION:Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report\nIn Part 1 of our IVD Deep Dive series\, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of clinical data for your IVD. \nPresented from the point of view of seasoned MDR-compliant CER medical writers\, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and identify sources of clinical data to support the Clinical Performance Report (CPR). \nKey Takeaways: \n\nDiscuss the purpose of the CPR and its role as a critical component of the PER\nIdentify sources of clinical data and analyze those data within the context of the\nperformance endpoints and acceptance criteria presented in the SVR\nDemonstrate how to extract\, organize\, and appraise these data within the CPR\n\nWatch the webinar recording. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical performance reports for IVDR submissions. \n  \nKey Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746\nIn vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC). \nOverview of In Vitro Diagnostic Regulation 2017/746 \nThe implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device\, an expansion of the Quality Management System\, and the increased need for Notified Body (NB) review. \nThe transition into IVDR is already underway. Consequently\, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed\, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ivd-deep-dive-series-part-2-clinical-data-sources/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
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ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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