How do you plan and conduct IVD performance studies that support the clinical evidence required under the IVDR?

The clinical evidence under the In Vitro Diagnostic Regulation (EU) 2017/746 does not emerge from a single study but from the interplay of three pillars that have to be demonstrated under Art. 56: scientific validity links the analyte to the clinical condition, analytical performance shows that the test measures correctly, and clinical performance shows that the result correlates with the clinical condition. This sequence is not arbitrary: if the clinical performance study is started before analytical performance has been demonstrated against the acceptance criteria from Annex I, it runs on a basis that can still collapse. The performance evaluation plan under Annex XIII is therefore the document that pulls the bottleneck forward: it defines which pillar has to be demonstrated, when, and against which acceptance criteria.

This is exactly where we come in: we build the performance evaluation plan so that analytical performance and the sample-size justification are in place before the costly clinical performance study under EN ISO 20916 begins. The results feed into the Performance Evaluation Report and the technical documentation, so that every performance claim is supported by concrete evidence. The post-market performance follow-up under Annex XIII keeps that evidence current after market launch and ties it to post-market surveillance and risk management under ISO 14971:2019. In this way the clinical evidence stays robust throughout the lifecycle instead of aging along with the certificate.