Enabling Predictability in Diagnostics: Inside the CLEARED CERSI Initiative

The CLEARED Centre of Excellence for Regulatory Science and Innovation (CERSI) is helping reshape how the UK approaches the regulation of in vitro diagnostic (IVD) tests — the technologies that detect diseases, guide treatment, and safeguard public health.

As regulatory requirements evolve in both the UK (MHRA) and EU (IVDR), manufacturers and clinicians face growing uncertainty about what counts as acceptable evidence of a test’s performance and safety. CLEARED CERSI exists to bring clarity, consistency, and collaboration to this space.

Through a partnership between the University of Leeds, University College London, and Psephos Biomedica, the programme is building practical guidance and shared standards that will make regulation more predictable, efficient, and transparent.

By combining regulatory science with real-world experience, CLEARED CERSI aims to speed up innovation, reduce duplication, and strengthen the evidence base that underpins diagnostic safety.Ultimately, the goal is simple: to help good tests reach patients faster — and keep them safe once they do.