关于本白皮书
本资源涵盖的关键主题
Clinical evidence requirements under IVDR are more demanding than many IVD manufacturers expect. The regulation introduces a structured, three-pillar framework — scientific validity, analytical performance, and clinical performance — that must be systematically planned, executed, and documented throughout the entire lifecycle of a device.
This whitepaper walks through the key documents required to demonstrate clinical evidence under IVDR: from the intended purpose and state of the art, through the performance evaluation plan and its three pillars, to the performance evaluation report. Written by senior IVD experts at QbD Group, it is aimed at IVD and companion diagnostic manufacturers preparing for IVDR compliance, whether they are developing a new device or transitioning a legacy product from IVDD.
What you'll learn
Key takeaways from this document
- Why the intended purpose is the foundation of all clinical evidence, and what it must include under IVDR
- How to define and document the state of the art (SOTA) and why it is kept separate from the scientific validity report
- What a Performance Evaluation Plan (PEP) must contain, and how to approach it for both new and legacy devices
- How to demonstrate the three pillars of clinical evidence: scientific validity, analytical performance, and clinical performance
- What belongs in a Performance Evaluation Report (PER) and how it ties together the full clinical evidence narrative
- Which common gaps and pitfalls to avoid, from insufficient clinical data to missing post-market performance follow-up
