14th Annual Outsourcing in Clinical Trials: Medical Devices Europe 2026
Talk Stream B: In Vitro Diagnostics Performance & Validation track
Navigating the new competent authority application process for companion diagnostics under IVDR
Tue, Jan 27, 2026 · 2:00–2:30 PM CET Holiday Inn Munich City Centre
About this session
- Understanding the updated competent authority application pathway for CDx under IVDR
- Sharing lessons learned from real-world submissions and post-application interactions
- Identifying best practices for aligning diagnostic and therapeutic regulatory timelines when engaging with authorities
Speaker
Reviews of this session
No reviews yet
Were you in the room? Reviews are open until Jan 28, 2027.