Mastering Clinical Performance Studies under IVDR

FROM STRATEGY TO DELIVERY

Are you prepared to tackle the challenges of clinical performance studies under the IVDR?

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On demand

1h

In Vitro Diagnostics

English

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Description

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.

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What you'll learn

• 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

Speakers

Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.

Don’t miss the opportunity to learn and engage with professionals in the field.

Annelies Rotthier

Scientific Affairs and IVD Clinical Evidence Manager

Annelies Rotthier is a senior IVD consultant. After her Ph.D. in Molecular Genetics at the VIB Institute in Antwerp, she pursued her career in the field of molecular genetics as R&D manager in the spin-off company Multiplicom and later as Director Product Development at Agilent Technologies, a major player in Next Generation Sequencing IVD applications.

She brings her experience to support companies with product development in compliance with IVD Regulation and with the transition to the new IVD Regulation. Risk management activities in accordance with ISO14971 is one of her main expertise.

Kirsten Van Garsse

Director Representative Service & Manager IVD - Regulatory Affairs

Kirsten Van Garsse obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has amassed extensive experience in the In Vitro Diagnostic Medical Device Industry. She joined Qarad, now part of the QbD Group, a consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, at the end of 2017.

In her role as Director of Authorized Representative Services & Manager of IVD Regulatory Affairs, Kirsten applies her wealth of experience to Regulatory Affairs projects, adeptly translating regulations into compliant business processes and applications. Additionally, she oversees the various Representation Services offered by Qarad, ensuring clients receive expert support in navigating regulatory requirements.

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Supported by our IVD experts

SHORT EXPLAINER VIDEOS

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.

Learn more

How to define your Clinical Performance Strategy?​

Learn how to define an effective clinical performance strategy for IVDs. Discover key steps, including setting a clear intended purpose, understanding the state of the art, defining performance characteristics, and assessing available data.

Learn more

What are the requirements for IVD Clinical Performance Studies Under IVDR and ISO 20916?​

Learn the essential requirements for conducting IVD clinical performance studies under the IVDR and ISO 20916:2024.

Learn more

When does Annex XIV apply in Performance Studies​?

Compliance with Annex XIV is essential for certain IVD performance studies under the IVDR, such as those involving surgically invasive sampling or interventional procedures. Discover when these requirements apply.

Learn more

Key Documentation for Annex XIV Compliance in Clinical Performance Studies​

For studies under Annex XIV, manufacturers must follow the rigorous process outlined in Article 58 of the IVDR. Learn about the key documentation required.

Learn more

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?​

For studies under Annex XIV, manufacturers must follow the rigorous process outlined in Article 58 of the IVDR. Learn about the key documentation required.

Learn more

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