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Clinical Evidence plays a pivotal role in IVDR compliance, serving as the main crucial aspect of IVD device safety and performance. The Clinical Evidence Concept has been introduced with the IVDR back in May 2017 (DoA IVDR), however the compliance in meeting these Performance Evaluation IVDR Requirements remained one of the number one challenges, resulting in a significant portion of identified deficiencies by the Notified Bodies during Technical Documentation Assessments.

Understanding how the intended purpose is governing the three pillars of the Clinical Evidence – Scientific Validity, Analytical Performance and Clinical Performance – as well as the continuous benefit/risk ratio assessment seems to remain challenging. In a collaborative webinar hosted by TÜV SÜD and Entourage, our experts will delve into optimal IVDR Clinical Evidence strategies. Participants will be gaining insights into the IVDR Clinical Evidence concept and how to manage these requirements efficiently.

Efficiency strategies will be discussed, e.g., how to potentially leverage Clinical Performance evidence for legacy IVD devices and how to consider the continuous Performance Evaluation Process in the organisational Quality Management System.

Join us to get invaluable insights from our world-class experts on how to understand the Clinical Evidence IVDR life cycle concept to ensure continuous safety and performance of state-of-the-art IVDs. Surveillance activities and management of the entire IVD life cycle have been one of the main aspects which have been reinforced and sharpened with the introduction of the IVDR in May 2017.

Webinar Outline

Topic 1: Clinical Evidence concept under the IVDR – a continuous approach

Topic 2: Lessons Learned from ~ 5 years IVDR NB experience

Topic 3: Understanding the clinical performance concept – how much is enough?

Topic 4: Clinical Evidence strategies – what data can be leveraged?

Conclusion & Q&A

Sessions

Session 1: Wednesday, 09th Oct 09:00 – 10:00 AM

Session 2: Wednesday, 09th Oct 03:00 – 04:00 PM