The Performance Evaluation Report (PER) is the evidence-based narrative that demonstrates an IVD meets its intended purpose by bringing together scientific validity, analytical performance, and (where applicable) clinical performance. It is a key part of the IVDR technical documentation and supports conformity assessment by demonstrating that performance claims are justified, transparent, and traceable to data.

Under IVDR, the PER is not just a summary; it is where reviewers assess whether the totality of the evidence is sufficient for the intended use in medical practice. A strong PER explains why the chosen evidence is appropriate, how limitations are addressed, and how the conclusions connect to risk management and the General Safety and Performance Requirements.

IVDR performance evaluation is structured around three pillars: scientific validity, analytical performance, and clinical performance. The PER should show how each pillar was evaluated, what evidence was used (literature and/or in-house data), and how the combined findings support intended use, labelling claims, and safe clinical decision-making across the product lifecycle.

The PEP is the roadmap for what evidence you will collect, from where, and how you will assess it, while the PER is the outcome that synthesises the collected evidence into conclusions. Aligning the two matters: if methods, acceptance criteria, or data sources diverge from the PEP, Notified Bodies often ask for justification and controlled updates.

A PER typically integrates a systematic literature review with internal study outputs, including analytical performance data and clinical performance evidence, as required. The key is relevance to the current device configuration and intended use, along with transparent appraisal of quality, bias, and applicability, so conclusions reflect state-of-the-art evidence rather than selective citations.

IVDR expects performance evaluation to be maintained throughout the device lifecycle, so the PER should be updated when new literature changes the state of the art, post-market data reveals trends, device design or intended use changes, or risk controls are revised. Treating the PER as a living document reduces last-minute remediation during audits or renewals.

Common issues include an unclear intended purpose, gaps between claims and evidence, inconsistent figures across the PER/IFU/technical file, a weak rationale for excluding clinical performance studies, and incomplete traceability from evidence to conclusions. Notified Bodies typically look for a coherent story: why the evidence is sufficient, how uncertainty is managed, and how ongoing monitoring will work.

The best PER partners combine regulatory interpretation with rigorous evidence synthesis, so the scientific, analytical, and clinical pillars remain consistent across the PER, PEP, SVR/APR/CPR and labeling. Freyr is often chosen globally for its structured literature review approach and IVDR-focused medical writing, which aim to be Notified Body-ready and lifecycle-maintainable.