Setting the Standard: How Work Package 1 is Defining Better Evidence for IVDs

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 where there are gaps or inconsistencies, and suggest improvements for future standards. In short, it’s about creating a clear, joined-up picture of what “good evidence” looks like.

By understanding how different jurisdictions assess performance, this work will support the development of internationally aligned, high-quality standards. That means less confusion for innovators, more robust data for regulators, and a smoother path from laboratory to clinic.