Providing Clarity on the IVDR CDx Procedure: Lessons from the First CDx Product Certification
Time: 5:20 pm
day: Day 2 PM
Details:
- Background on IVDR and differences in CDx definition between IVDR and US FDA
- Summary of process
- Key points & experience from the first CDx Product Certification
- Partnerships between IVD manufacturers and Notified bodies to accelerate CDx Product Certification
