MedTech Europe has released a free, 169-page eBoook on "Clinical Evidence Requirements under the EU IVDR Regulation."
Find it here:
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AI Corner:
Here’s a big-picture overview of the MedTech Europe eBook – Clinical Evidence under IVDR (4th ed., 2025).
The MedTech Europe eBook provides a practical, industry-oriented guide to meeting the clinical evidence requirements of the EU In Vitro Diagnostic Regulation (IVDR 2017/746). It explains how manufacturers must show that their devices are not only technically reliable but also clinically relevant and safe in the context of modern medical practice.
At the heart of IVDR is the concept of performance evaluation as a continuous process built on three linked elements: scientific validity (showing that the biomarker or analyte is genuinely associated with a clinical condition or physiological state), analytical performance (the ability of the test to measure that analyte accurately and reproducibly), and clinical performance (evidence that the test’s results correspond to the clinical state or outcome it claims to inform). Together, these elements constitute the clinical evidence that must underpin a device’s CE marking and ongoing benefit-risk profile.
A recurring theme is the central role of the device’s “intended purpose”—what is measured, in which sample, for which patient population, and for what clinical function (diagnosis, screening, monitoring, therapy guidance). This declared purpose drives the design of studies, the choice of performance indicators, and post-market follow-up. Equally important is the need to show that the device remains aligned with the “state of the art in medicine”—not necessarily the newest technology, but the practice currently regarded as good and effective care in Europe. As medical practice and competing technologies evolve, manufacturers are expected to monitor whether their own devices continue to offer a favorable benefit-risk profile.
The document stresses a risk-based approach. Higher-risk IVDs (notably Class C and D devices such as companion diagnostics, infectious-disease assays, and complex genomic tests) typically require more robust clinical performance data—often from prospective or multi-site studies—while lower-risk devices may rely more on literature and routine-use data. Real-world evidence and published experience can supplement or, in some cases, substitute for formal clinical performance studies, provided the data are of suitable quality. The guidance also clarifies that clinical utility—the impact of the test on patient management—is generally not demanded by IVDR, except in special cases such as companion diagnostics.
Overall, the eBook highlights the cultural and regulatory shift from the older IVDD regime, which emphasized technical specifications, to the IVDR framework, which places clinical relevance and continuous evidence generation at the center of IVD regulation. It positions compliance not as a one-time hurdle but as an ongoing process that links the declared purpose of a device to the scientific understanding of the biomarker, to demonstrable technical reliability, and finally to its role in real clinical decision-making within current medical practice.
