This eBook is a collection of questions and answers designed to support manufacturers in navigating their performance evaluation obligations under the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.
The content reflects the collective expertise of numerous regulatory and clinical professionals, including both members of MedTech Europe and a range of external experts and contributors. It has been developed as a practical resource, grounded in the real-world experience of the IVD industry and enriched by continuous feedback from Notified Bodies.
We are pleased to present the Fourth Edition (August 2025), which builds on the foundation of previous versions and incorporates the latest insights and developments in the field.
This edition includes the following updates:
• Chapter 7 on Companion Diagnostics has been revised, now featuring new questions that reflect the latest trends and stakeholder feedback.
• Chapter 14 on Clinical Evidence for Next Generation Sequencing (NGS)-based IVD Assays, with a particular focus on oncology applications.
• Chapter 15 on Real-World Evidence, acknowledging its growing importance in IVD development and assessment.