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VISION & ORIGINS

The CLEARED CERSI IVD Network was established to strengthen regulatory science for diagnostic technologies ensuring that innovative, AI-enabled, and digital diagnostics reach patients safely and effectively.

PHASE 1

Phase 1 (Discovery, 2024) was led by University College London (UCL) in partnership with Psephos Biomedica, Insightful Health Ltd, and Act-IVD, sponsored by the MHRA and funded by Innovate UK. This phase identified key regulatory challenges and delivered foundational frameworks for evidence-based documentation and post-market surveillance.

Now in Phase 2 (Implementation, 2025–2026), led by Psephos Biomedica in collaboration with University College London, University of Leeds, Insightful Health Ltd, and Act-IVD, CLEARED CERI IVD is building practical methodologies, data tools, and a collaborative virtual network positioning the UK as a global leader in diagnostic regulatory science and innovation.

PHASE 2

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© 2026 by CERSI IVD. All rights reserved.

CERSI-IVD: Centre of Excellence for Regulatory Science and Innovation (CERSIs) of In Vitro Diagnostic (IVD) tests. Clinical Evaluation and Assessment for Regulation of In Vitro Diagnostic tests (CLEARED IVD).

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