Panel Discussion: Defining a Unified Path Towards IVDR Compliance for Streamlined Approvals
- How has IVDR changed expectations for evidence generation, documentation, and timelines across regulators, notified bodies, pharma, and diagnostic developers?
- Is there any strategy change in aligning with notified bodies and regulators?
- What are the most common bottlenecks companies encounter during co-development; from clinical trials to MAA and conformity assessment?