CERSI IVD

Great regulation depends on great communication. Work Package 3 is creating a new virtual platform to connect researchers, regulators, and industry experts working in diagnostic science. Built around security, collaboration, and accessibility, the platform will allow members to share knowledge, access training, and contribute to live projects in a trusted online space. Features include group workspaces, event listings, resource libraries, and digital recognition for contributors — all...

Once an IVD test reaches the market, the real-world evidence begins. Post-market surveillance (PMS) ensures tests continue to perform safely and effectively over time — but the methods for doing this are often unclear or inconsistent. Work Package 2 of CLEARED CERSI is focused on improving those methods. The team is exploring how best to design and analyse PMS studies using real-world data, from hospital systems to national reporting databases. They are developing and testing statistical...

Before a diagnostic test can be used, it must prove it works accurately and reliably. But the rules on how to show that evidence differ widely around the world. Work Package 1 of CLEARED CERSI is tackling this challenge head-on. The team is reviewing every major international regulation and standard related to IVD performance evaluation — from ISO and CLSI guidance to frameworks under the MHRA’s Comparable Regulatory Country scheme. The aim is to map what guidance currently exists, identify...