Clinical performance studies
EN ISO 20916:2024 under IVDR: what harmonisation changes—and what it does not
A practical explanation of EN ISO 20916:2024, its harmonised status under IVDR and the evidence a clinical performance study still needs beyond standards alignment.
Published · Reviewed
Executive answer
Commission Implementing Decision (EU) 2024/2625 added EN ISO 20916:2024—the European adoption of ISO 20916:2019—to the IVDR harmonised-standards list. Following the harmonised standard can support a presumption of conformity only for the IVDR requirements and standard clauses actually covered. It remains voluntary, and it does not by itself establish scientific validity, analytical performance, clinical performance or an adequate study design for a particular device.
Key points
- EN ISO 20916:2024 is the European adoption of ISO 20916:2019; it is not a new 2024 edition of the underlying ISO document.
- Harmonised standards remain voluntary under IVDR.
- Presumption of conformity is limited to the legal requirements and clauses the cited standard covers.
- The protocol must still justify population, specimen, comparator, endpoints, sample size and statistical analysis for the intended purpose.
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.
How FirsTeckBio uses the standard
We use EN ISO 20916 as a study-quality backbone, then connect it to IVDR Annex XIII and the device-specific evidence plan. This keeps the protocol, operational documents, analysis and clinical performance study report aligned to the same intended purpose.
The result is not a generic standards checklist. It is a study package in which each design choice has an owner, a rationale and a defined place in the final performance-evaluation evidence chain.
Primary sources and review
Reviewed by the FirsTeckBio Regulatory & Clinical Team. This article is general information, not legal or regulatory advice for a specific device.