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We’re proud to highlight a new publication by Pieter Bogaert, PhD—senior RA IVD consultant at QbD Group—recently featured in RAPS Regulatory Focus. In this expert piece, Pieter shares practical insights for IVD manufacturers striving to meet the EU IVDR’s evolving clinical evidence requirements.
In the EU, demonstrating safety and effectiveness is not a one-time task. Under the IVDR, clinical evidence must be continuously generated and re-evaluated, with a clear link to both state-of-the-art and risk management practices.
This article offers:
- A breakdown of the three key pillars of clinical evidence: scientific validity, analytical performance, and clinical performance
- Clear guidance on tailoring your approach based on device risk class and type
- Best practices for evaluating the state of the art and integrating it into your performance evaluation
- Clarification of postmarket performance follow-up (PMPF) requirements—and how they support your benefit-risk assessment
Whether you're compiling a performance evaluation report or refining your PMS and PMPF strategies, this article is a valuable resource for navigating EU IVDR compliance.
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