IVD performance evaluation
On May 23, 2022, the IVDR (In Vitro Diagnostic Medical Devices Regulation) replaced the IVDD (in vitro Diagnostic Medical Devices Directive). This change requires all novel assays entering the EU market to undergo a structured IVDR performance evaluation, covering the three central pillars: scientific validity, analytical performance, and clinical performance. Established assays may also require reassessment to maintain their CE mark and meet updated IVDR requirements. This is where Biocult plays a pivotal role.
Why choose Biocult?
Performance evaluation at Biocult goes beyond the execution of tests. With deep expertise, clear communication, and flexible project management, we support clients from the initial planning phase to the final evaluation report.
We have extensive experience in IVD assay development and validation studies across cardiovascular, hemostasis, and infectious disease domains. Our laboratory houses a broad range of clinical analyzers used for reference testing, enabling us to support both small-scale and high-throughput studies.
Our verification and validation (V&V) experts work with handheld devices as well as full-size clinical analyzers, ensuring robust datasets for your IVDR submission. This combination of operational competence and scientific knowledge strengthens every project we support.
Understanding IVDR performance evaluation
A full IVDR performance evaluation combines scientific validity, clinical and analytical performance, and continuous evidence collection to ensure that an assay is not only functioning correctly but is also safe, reliable, and aligned with its intended purpose under the IVDR framework. Biocult supports clients in meeting these requirements by providing structured guidance, high-quality study execution, and clear documentation that aligns with regulatory expectations.
Our IVDR service
With more than twenty years of experience, we provide a complete set of services designed to support your IVDR transition. We help clients navigate all essential elements of the IVDR performance evaluation plan, performance studies, and reporting requirements. Our network of partners allows us to cover all three pillars of IVDR:
- Scientific validity
- Analytical performance
- Clinical performance
Additionally, we offer professional sample sourcing, customized analytical performance services, and in-house support through a dedicated sourcing team. Our services follow the latest IVDR requirements and are designed to streamline the process from planning to submission.
Clinical & analytical performance studies
To support your performance evaluation, we provide all studies required under Annex I, Section 9.1a of the IVDR, which form the foundation for clinical and analytical performance evaluation and ensure your assay is ready for notified body review. These include assessments of analytical sensitivity and specificity, trueness, precision, and accuracy.
Supporting your IVDR compliance & performance evaluation studies
Biocult helps clients maintain ongoing IVDR compliance by supporting updates to performance documentation, managing sample sourcing, and ensuring that all evidence aligns with the performance evaluation report (PER) and other key regulatory documents.
Would you like to learn more about Performance Evaluation Studies? We’d love to hear from you via our contact form. We look forward to supporting your performance evaluation needs.
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Let’s make something great together. Feel free to contact us for more information via the contact form.