Beyond Approval: Building Better Post-Market Surveillance through Work Package 2

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 models that can detect early signs of problems — for example, unexpected shifts in performance — while avoiding false alarms. This research will help shape future UK guidance on PMS study design, data collection, and analysis.

As new technologies like AI-enabled diagnostics emerge, this work is vital. Reliable PMS systems will help regulators, manufacturers, and clinicians maintain trust in diagnostic innovation — ensuring that safety and quality never stop at approval.