Date: 9 July 2026
Time: 16:00 - 17:00 CET | 10:00 - 11:00 am EDT
Location: Virtual
Introduction
This webinar provides a high-level overview of IVD performance studies and touches upon the evolving considerations for companion diagnostics (CDx) within the current European regulatory framework. Industry experts from Qserve and TÜV SÜD will discuss common challenges, expectations observed in practice with respect to performance studies, and CDx-related activities.
The session will explore current IVDR requirements; relevant guidance documents, including ISO 20916, and practical considerations encountered during performance study planning and execution. Speakers will also highlight common pitfalls and trends observed during interactions with manufacturers and notified bodies.
Attendees will gain valuable insight into the complexity of performance studies, the CDx landscape, and the importance of leveraging the right expertise when navigating uncertainty within this rapidly evolving field.
The session features a 45-minute informal presentation followed by a live Q&A. You can submit your questions through the registration form, by email at marketing@qservegroup.com, or directly during the event.
Agenda:
- Welcome and Introduction
- Introduction to IVDR, performance/clinical and CDx studies (Qserve)
- Understanding complexity of Companion Diagnostics under IVDR
- Understanding Standalone IVD Performance Studies (TÜV SÜD)
- Notified Body Perspective, Common Challenges and Pitfalls (TÜV SÜD)
- Looking Ahead, From Performance Studies to CDx Applications (Qserve & TÜV SÜD)
- Live Q&A.
Learning Objectives:
By attending this webinar, participants will:
- Gain a high-level understanding of companion diagnostics and IVD performance studies under IVDR
- Understand key differences in performance studies and CDx-related activities
- Learn about common challenges, current expectations, and practical considerations observed by Qserve and TÜV SÜD.
Who should attend?
This webinar is designed for professionals involved in the development, regulation, quality, or clinical evaluation of in vitro diagnostic medical devices, including:
- Regulatory Affairs professionals
- Clinical Affairs and Clinical Operations teams
- IVD manufacturers and developers
- Companion diagnostic developers
- Quality Assurance professionals
- R&D and Product Development teams
- Medical Writing professionals
- Professionals involved in IVDR transition activities
- Organizations exploring standalone IVD performance studies or future CDc applications.