Panel Discussion: Strengthening the Interface between Competent & Notified Bodies to Define a Unified Path Towards IVDR Compliance for Streamlined Approvals
Time: 8:30 am
day: Day 2 AM
Details:
- What are the current and future expectations for CDx conformity? How closely are the new UK regulations expected to mirror or diverge from IVDR?
- How are stakeholders harmonizing the interpretation of performance studies, from a technical and regulatory perspective?
- How is the changing global landscape of laboratory developed tests expected to impact biomarker driven trials?
