Annelies Rotthier

15 years of experience in IVD field · Business Unit Manager IVD CRO

IVD Clinical Evidence and Medical Writing. IVD Product Development and IVDR Compliance. Strategic leadership & Consultancy.

8 articles

Clinical20 may 2026 4 min

What to Look for When Selecting a CRO for IVD Performance Studies

Not every CRO is equipped for IVD performance studies. Learn the nine capabilities that matter most for compliant, defensible evidence generation.

Clinical20 may 2026 5 min

Three Sponsorship Models for Combined IVD-Drug Studies: How to Choose the Right One for Your Program

Explore the three main sponsorship models for combined IVD-drug studies and learn how governance structures impact compliance, timelines, and data ownership.

Clinical20 may 2026 3 min

Delegation vs. Transfer of Sponsor Responsibilities: The Line Every IVD Performance Study Sponsor Needs to Draw

Understand the difference between delegating operational tasks and transferring Sponsor responsibilities in IVD performance studies under IVDR and FDA frameworks.

Clinical20 may 2026 4 min

Who Is the Sponsor of Your IVD Performance Study and Why It Matters More Than You Think

Learn who carries Sponsor responsibility in IVD performance studies and why this role shapes compliance, data ownership, and regulatory success.

Clinical30 mar 2026 1 min

Sponsor Responsibilities in IVD Clinical Performance Studies

Understand sponsor responsibilities in IVD clinical performance studies across IVDR, applicable FDA requirements (including IDE where relevant), and ISO 20916, including delegation, CRO roles and combined study models.

Regulatory Affairs10 oct 2025 3 min

IVD Use in EU Clinical Trials: Key Considerations Under the IVDR

Unsure whether your IVD requires a legal representative under the IVDR? Learn the difference between in-house use, performance studies, and companion diagnostics.

Regulatory Affairs10 oct 2025 5 min

Bridging the Regulatory Gap: Integrating IVDs into Global Clinical Trials

Learn how to integrate IVDs into global clinical trials while meeting IVDR and CTR requirements. Practical tips, real-world cases, and QbD expertise.

Clinical25 jun 2025 1 min

IVDR Compliance for Large-Panel Next-Generation Sequencing (NGS) Devices: A Strategic Guide

Achieve IVDR compliance for large-panel Next-Generation Sequencing (NGS). Validate genetic variants and meet performance requirements with the right strategy.

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