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 notified bodies harmonising their interpretation of performance studies, from a technical and regulatory perspective?
- What is the expected interplay between IVDR and the enforced European AI act? And what is the regulatory pathway expected for the registration of an AI-driven diagnostic or medical device?
- How are US LDT regulations expected to impact the industry, and in what ways do they align with or differ from the IVDR framework?
