MedTech Europe has released the fourth edition of its eBook “Clinical Evidence Requirements under the IVDR (EU) 2017/746”, a key resource to support manufacturers with performance evaluation obligations.
What’s new in this edition (August 2025)?
- Expanded guidance on Companion Diagnostics (Chapter 7).
- A new chapter on NGS-based IVD assays in oncology (Chapter 14).
- A new chapter on Real-World Evidence (Chapter 15).
- Updated references and standards in line with best practices.
At Asphalion, we see this as a valuable tool to help IVD developers ensure compliance, foster innovation, and bring safe and effective diagnostics to patients.
You can download the full guide here: 4th edition of Clinical Evidence requirements under the IVDR Guide
We can help you navigate this regulatory requirements. Contact us at: [email protected]
