Building an IVDR performance evaluation plan: from claims to evidence

1. Define the product and the claim being evaluated

Before choosing a template, identify the device version, assay configuration, specimen types, users and clinical role. The scope needs to be specific enough for another reviewer to understand which product the evaluation covers. A platform name alone does not establish the scope of every assay or configuration offered on it.

Gather the current instructions for use, design inputs, risk documentation and commercial description. Resolve differences in the intended purpose before they are repeated in research plans. When a future claim is still under development, identify it separately from the claim supported by the present device and evidence.

2. Make the evidence map an instrument for decisions

Use a working table to connect each performance claim to its evidence question. Include the underlying document and version, the assessment of applicability and the decision still required. This makes the table more useful than a list of reports that simply marks every file as present.

3. Distinguish evidence gaps from presentation gaps

A complete study may be difficult to evaluate because the report lacks a clear cross-reference or explanation of the tested version. That is different from a study that never included a specimen type now listed in the intended purpose. The first issue may be resolved through controlled clarification; the second may require additional evidence or a change to the claim.

For each gap, describe the unanswered question and why it matters. Rank work according to its effect on the evaluation and the dependencies it creates. A major change to the clinical role may need to be resolved before a protocol is finalised, while formatting corrections can proceed independently. Avoid assigning a study simply because a standard template has a blank section.

4. Test the plan against a realistic change

Consider a hypothetical assay currently evaluated with serum that is proposed for an additional specimen type. The plan should identify which existing conclusions may still apply and which characteristics need review. Specimen collection, handling, interference and comparability may each create questions; the precise work depends on the device and claim.

The example illustrates a planning method, not a universal test package. The decision record should explain the applicable question, available support, missing evidence and proposed resolution. That makes the resulting work understandable to laboratory, clinical, quality and regulatory colleagues.

5. Assign outputs and update triggers

Assign an accountable owner for every evidence activity and define the output that will enter the evaluation. Document assumptions about specimen availability, external data access and report readiness. If those assumptions change, assess the impact on the planned conclusion and schedule rather than silently carrying forward the original dates.

Define when new literature, a device change, post-market information or a change in clinical practice requires review. Preserve the previous plan and the reason for revision. The PEP and PER should remain connected throughout the device lifecycle, with the current conclusion supported by an identifiable body of evidence.