The new in vitro diagnostics regulation of the European Union, the IVDR 2017/746, will soon be replacing the existing IVD Directive on May 26th, 2022. The regulation is set to bring in drastic changes to the way the IVD medical devices are regulated by strengthening the old requirements in a variety of facets.
The IVDR changes have greatly increased the requirements for Performance Evaluations, which are conducted in the premarket phase. Further, it also mandates that the performance of devices be continuously monitored throughout the life cycle of the device. This continuous data collection and analysis will become an integral part of the Performance Evaluation Report (PER).
Join this featured presentation from our RA/QA Subject Matter Expert, Joseph-Richardson Larbi, who will cover the essential components of a PER and how to best prepare your technical documentation. He will also go over how to demonstrate an acceptable benefit-risk ratio and comply to the IVDR’s GSPRs for both legacy and new IVD medical devices. This session will also discuss the requirements for drafting a PER and the common pitfalls to avoid based on Celegence’s current IVDR projects.
Celegence will be hosting the WEBINAR on Tuesday, November 16th at 10 am EST. Register online now.