Mastering Clinical Performance Studies under IVDR
from strategy to delivery​
The regulatory landscape for in vitro diagnostic (IVD) devices is constantly evolving, making it critical to provide evidence of your device’s clinical performance. This webinar will delve into the strategic, regulatory, and operational aspects of conducting successful clinical performance studies.
With input from IVD experts, we’ll explore what it takes to create a robust and compliant study design, effectively source samples and sites, and meet the unique challenges posed by self-testing and near-patient testing devices. Additionally, our panel will discuss the requirements outlined in Annex XIV of the IVDR and provide tips on managing performance study applications across EU Member States.
Whether you’re preparing for a new submission or looking to refine your current approach, this session is designed to provide actionable guidance to help you succeed.
- 5 December 2024 | 16:00 CEST
Register and learn about following topics
- Collect reliable clinical data
- Align with regulatory requirements
- Design effective study plans
- Source samples and select sites
- Self-testing and near-patient testing considerations
- Common assessment gaps from notified bodies
- Key points of Annex XIV
- Manage applications across EU Member States
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Speakers
Annelies Rotthier
Scientific Affairs and IVD Clinical Evidence Manager
Kirsten Van Garsse
Director Representative Services & Manager IVD - RA
Kirsten Van Garsse holds a master’s degree in biomedical sciences from the Vrije Universiteit Brussel (VUB), obtained in 2002. With over two decades of experience in the In Vitro Diagnostic Medical Device Industry, she has excelled in various roles.
Since joining Qarad, now part of the QbD Group, in 2017, Kirsten has been pivotal in driving regulatory compliance and quality initiatives. As a Regulatory Affairs Manager, she translates complex regulations into compliant business processes while in her role as Authorized Representative Director, she oversees all Representation Services.
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Supported by our IVD experts
SHORT EXPLAINER VIDEO
Why is Clinical Performance key to a successful IVDR submission?
Did you know that the IVDR mandates robust clinical evidence to support the validity and performance of IVD assays? In this article we’ll explore the role of Clinical Performance in a smooth IVDR submission.