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Evaluation

Medical Devices

Maximizing the Value of Clinical Data for Global Submissions (EU/China)

Wednesday, May 14, 2025
12:00 - 13:00 CEST
Location: Studio 211 + 212 (level 2)
Learning Level: Intermediate
Description: This session covers strategies for maximizing clinical data value, navigating regulatory frameworks, and implementing effective clinical, PMS, and Real-World Evidence (RWE) strategies. We will present Notified Body experience from real-case clinical and PMS file reviews for CE marking. We will provide an overview of NMPA requirements for clinical evaluations and how they differ from MDR. We will also explore how to align clinical investigations with business objectives while considering the use of clinical data across regions. Finally, we will dive into practical examples of collecting RWE in the post market phase, to establish an effective clinical data collection system for device’s safety and performance in the real-world clinical use scenarios.

Learning Objectives:

  • participants will be able to identify and implement strategies to maximize the value of clinical data pre- and post-market launch while navigating various regulatory frameworks.
  • participants will be able to differentiate between NMPA and MDR requirements for clinical evaluations and understand how to design high quality clinical investigations to facilitate the use of clinical data for submissions in different markets, in line with business objectives.
  • participants will be able to utilize practical examples of collecting RWE in the post-market phase to establish an effective clinical data collection system supporting regulatory compliance and market needs.