EN ISO 20916:2024: applying the harmonised standard under IVDR

What changed in 2024?

The European Commission added EN ISO 20916:2024 to the harmonised standards supporting Regulation (EU) 2017/746. The reference is based on ISO 20916:2019, which sets good-study-practice principles for planning, designing, conducting, recording and reporting clinical performance studies for IVD medical devices.

The important distinction is between the international ISO publication date and the European harmonised reference. Describing this as a completely revised 2024 ISO standard would be inaccurate. The change is its European adoption and citation for IVDR purposes.

What does presumption of conformity mean in practice?

When a manufacturer applies the cited standard correctly, the covered requirements may be presumed to conform. That can make the technical-documentation argument clearer because the chosen method is tied to a recognised European reference.

The presumption is not blanket approval. A manufacturer should identify the applicable clauses, explain exclusions and document any alternative method. A notified body can still examine whether the protocol is appropriate for the device, intended population, specimen type, clinical setting and claimed performance.

What should appear in the study file?

A defensible file shows how the intended purpose becomes a research question and how that question drives the protocol. The route from claim to endpoint should be visible before enrolment begins, not reconstructed after the database is locked.

• A documented intended-purpose and clinical-performance claim map.
• A justified target population, specimen pathway and inclusion/exclusion framework.
• Comparator selection and acceptance criteria linked to current practice.
• Sample-size assumptions, analysis populations, missing-data rules and predefined statistics.
• Ethics, consent, safety reporting, monitoring, deviations and data-integrity controls proportionate to the study.

Connecting the standard to the evidence plan

Map the applicable EN ISO 20916 clauses to IVDR Annex XIII and the device-specific evidence plan. Use this mapping to review the protocol, operational documents, analysis and clinical performance study report against the intended purpose.

For each design decision, record its rationale, responsible reviewer and supporting document.

Build a protocol review that tests decisions, not document headings

Start the review with a single claim and follow it through the protocol. Identify the population that will support it, how eligible specimens reach the study, which measurements will be collected and what comparison will be made. Then ask whether the planned result would actually answer the claim. A protocol can contain all the expected headings and still leave this chain incomplete.

For example, an intended purpose involving a particular clinical setting needs a recruitment and specimen pathway that represents that setting. Convenient stored specimens may be useful, but their origin, handling and selection need to be understood. Record which decisions are supported, which need clarification and which require the design to change. This review record becomes useful during protocol approval and later when explaining deviations.

Run a specimen-to-report exercise before activation

Use a fictional participant or specimen record to walk through consent or other applicable arrangements, eligibility, specimen identification, testing, data entry and query resolution. Check whether each handover has an owner and whether the record retains the information required by the analysis. This is a practical way to identify a missing field or ambiguous instruction before it affects study data.

The exercise should include an exception: an insufficient specimen, an invalid test or a missing comparator result. The team should know where to record it and how to seek a decision. Avoid inventing exclusion rules at the point of data cleaning. Operational readiness also includes trained staff, approved documents, supplies and the applicable permissions; a successful exercise does not replace those requirements.

Maintain the standard mapping when the study changes

Keep the applicability assessment linked to the protocol version. A change to the specimen pathway, endpoint or testing workflow may affect more than one procedure. Review associated training, data collection and analysis instructions together, and retain the reason for the decision. Simply changing the standard reference in the bibliography will not show how the study was controlled.

The practical output is a traceable set of decisions: the applicable requirement, its implementation, the supporting record and any justified limitation. It helps the manufacturer explain the study coherently while preserving the distinction between following a standard and demonstrating the device-specific performance claimed.