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Medical Devices

Clinical Evaluation: Complexity in Simplicity: Regulatory Challenges for Standard of Care Medical Devices

Wednesday, May 8, 2024
11:45 – 12:45 CEST
Location: C 01
Learning Level: Advanced
Description: The world of medical devices isn't limited to complex machinery and cutting-edge technology. In fact, some of the most common and seemingly simple devices, such as cotton pads, nasal tampons, irrigation solutions, and suction tubes, play crucial roles in patient care. However, establishing their clinical benefits with measurable, meaningful parameters and defining safety and performance acceptance criteria based on state-of-the-art poses unique challenges.

This solution circle aims at exploring the difficulties faced by manufacturers, regulators, and healthcare professionals when establishing benefit-risk profiles for these essential devices. Through a comprehensive examination of case studies, real-world examples, and regulatory guidance, participants will gain valuable insights into the complexities of these seemingly simple devices.

Learning Objectives:

  • Identifying Clinical Benefits: Explore strategies and methodologies for establishing clinically relevant benefits, including measurable parameters, for "simple" medical devices.
  • Safety and Performance Criteria: Discuss the challenges and best practices for defining safety and performance acceptance criteria specific to simple devices.
  • Real-World Case Studies: Examine real-world examples to gain practical insights into navigating regulatory hurdles and benefit-risk assessments.