Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report
In 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.
Presented 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).
- Discuss the purpose of the CPR and its role as a critical component of the PER
- Identify sources of clinical data and analyze those data within the context of the
performance endpoints and acceptance criteria presented in the SVR
- Demonstrate how to extract, organize, and appraise these data within the CPR
Watch the webinar recording.
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical performance reports for IVDR submissions.
Key Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746
In 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).
Overview of In Vitro Diagnostic Regulation 2017/746
The 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.
The 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.
Read more on this topic in our blog post, here.