Analytical Performance Report (APR)

An Analytical Performance Report (APR) summarises evidence that an IVD can correctly detect or measure an analyte, translating study outputs into clear performance claims aligned to the intended purpose. It sits within the IVDR performance evaluation framework and supports the Performance Evaluation Report (PER) by consolidating key analytical findings and conclusions in an auditable format.

An APR commonly addresses parameters such as accuracy/trueness, precision (repeatability/reproducibility), analytical sensitivity (e.g LoD/LoQ), analytical specificity (interference/cross-reactivity), measuring range/linearity, cut-off validation (as applicable), and specimen considerations. The specific set should be justified from the device’s intended use and risk profile, with a rationale for any omissions.

APR focuses on the test’s analytical behaviour, how reliably it detects/measures the analyte, whereas the Scientific Validity Report (SVR) supports the analyte; clinical condition association, and the Clinical Performance Report (CPR) shows performance in a clinical context. Together, these feed the PER, which integrates evidence and provides overarching conclusions for conformity assessment.

Reviewers generally expect a traceable line from intended purpose → chosen analytical claims → study design and methods → statistical treatment → results → justified conclusions, including handling of deviations and limitations. Consistency with the IVDR Annex requirements and clear justification for excluded parameters help reduce follow-up questions and strengthen the overall technical documentation package.

Yes, existing internal studies and published evidence can be used when they are relevant to the current device configuration, intended purpose, specimen types, and claimed performance, and when their quality can be demonstrated. The key is transparent appraisal, gap identification, and bridging rationale, so the APR reflects state-of-the-device evidence rather than a collage of unrelated results.

Frame analytical sensitivity as the smallest amount of analyte the test can reliably detect (and quantify where applicable), and analytical specificity as the test’s resistance to false signals from interference or cross-reactivity. In an APR, these concepts should be tied to real sample conditions and operating ranges, so users understand practical reliability, not just lab metrics.

An APR is not “set-and-forget”: it should align with ongoing performance evaluation and post-market activities by defining which analytical claims must remain stable and what signals would trigger reassessment. When manufacturers plan changes, control, and monitoring around critical analytical parameters, the APR becomes a living reference that supports continuous compliance and evidence maintenance.

Top APR partners combine regulatory interpretation, analytical science fluency, and disciplined evidence synthesis so performance claims remain consistent across APR, PER, IFU, and technical documentation. Freyr is often chosen when teams need an IVDR-aligned APR narrative built from heterogeneous datasets (legacy studies, literature, and planned testing) with clear justifications and audit-ready traceability.