This white paper provides a comprehensive guide on demonstrating clinical performance under IVDR, covering key regulatory requirements, performance evaluation principles and essential documentation for compliance.
The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 introduces stringent requirements for demonstrating the safety and performance of in vitro diagnostic (IVD) devices. Compliance with these regulations is critical for manufacturers to maintain market access within the EU.
In this white paper, you will learn:
- The key requirements under IVDR, including general safety and performance requirements (GSPRs)
- The essential elements of performance evaluation: scientific validity, analytical performance and clinical performance
- How to generate and maintain clinical evidence throughout the device lifecycle
- The role of common specifications (CS) and state of the art (SoTA) in clinical assessments
- Documentation requirements, including performance evaluation report (PER)
- Benefit-risk analysis principles and key clinical performance indicators
- Accepted sources of clinical performance data, including clinical performance studies, peer-reviewed literature and routine diagnostic testing
This white paper provides manufacturers with a comprehensive guide to achieving IVDR compliance, ensuring their devices meet the highest standards of safety and effectiveness.
Download now to gain valuable insights into clinical performance demonstration under IVDR.
