Establishing and Maintaining the Right Level…

Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR

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 is provided, along with best practices for evaluating the state of the art and integrating it into your performance evaluation. It clarifies postmarket performance follow-up (PMPF) requirements and how they support your benefit-risk assessment.

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.

https://www.raps.org/news-and-articles/news-articles/2025/3/establishing-and-maintaining-the-right-level-of-cl

About the author

Pieter Bogaert

Senior Consultant IVD - Regulatory Affairs

Pieter Bogaert is a Regulatory Affairs Consultant and ISO 13485 Lead Auditor specializing in in vitro diagnostic medical devices (IVD). With expertise in European regulations, he supports IVD manufacturers, pharma and biotech companies, and EU laboratories in achieving compliance with the In Vitro Diagnostic Regulation (IVDR).

His consultancy covers regulatory strategy, quality management system compliance, risk management, performance evaluation, and technical documentation submissions. As Co-Chair of the RAPS Belgium Local Networking Group, Pieter actively contributes to the regulatory affairs community. With a background in biomedical sciences, he brings hands-on and managerial experience in medical laboratories, CE-marked IVDs, and in-house developed tests for clinical drug trials.

About the Author

Pieter Bogaert

PhD Biotechnology · Senior Consultant IVD – Regulatory Affairs

Pieter is a Senior IVD Regulatory Affairs Consultant at QbD Group, specializing in EU IVDR compliance, clinical evidence requirements, and regulatory strategy for diagnostic devices.

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