Archives: Agenda

• See how to align robust clinical evidence for MDR from an NB perspective
• Bridge the gap between reviewer expectations and sponsor realities
• Optimize clinical trial design and submissions for smoother approval

Chair: Dominic Tong, Senior Analyst, Medical Devices, GlobalData

• Medical device evidence is shifting from one-off trials to continuous, lifecycle-long evidence, with growing emphasis on post-market and real-world data and performance
• Episodic evidence generation models, designed around isolated studies and outsourced delivery, are increasingly misaligned with these expectations and introduce cost, delay and duplication at scale
• How medtech teams can use a single, versatile and affordable platform to run feasibility studies, trials, PMS and RWE in-house, enabling faster evidence generation and systematic reuse across the lifecycle
• A surgical robotics case study showing how clinical trial capabilities are brought in-house and a global clinical registry is leveraged to support evidence generation pre- and post-market

• Tracing the evolution of IVDR governance and how MDCG working groups shaped today’s framework and merged responsibilities over recent years
• Exploring behind the scenes of performance study assessments, including what is discussed within the competent authority review process and how applications are evaluated
• Sharing practical recommendations, common pitfalls, lessons learned, and strategies for preparing approval-ready submissions

• How an all-in-one eClinical platform simplifies medical device trial operations
• Why API-first interoperability is critical for device studies
• Practical AI use cases that support, rather than replace, clinical teams

• 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

• Spotting compliance risks early for novel or AI-enabled devices
• Best practices for bridging clinical and regulatory teams
• Lessons from recent reviews and practical recommendations for sponsors

• Discussing lessons learned from coordinated assessments for medical devices under Article 78
• Considering the impact of the European Commission’s pilot project for IVD stakeholders
• Sharing practical approaches for preparing evidence packages and coordinating with multiple authorities during assessments

Moderator: Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

• Piloting practical tools and workflows for collecting high-quality data across international sites
• Navigating local requirements and global compliance for multi-country observational programs
• Integrating imaging, monitoring, and electronic trial master files to strengthen data integrity and site collaboration