In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects
ISO 20916:2019 specifies good study practice for clinical performance studies of in vitro diagnostic (IVD) medical devices carried out using specimens from human subjects. It establishes principles for the ethical conduct, planning, design, conduct, monitoring, recording, and reporting of such studies — including the clinical performance study plan (CPSP), the roles and responsibilities of sponsor and investigator, informed consent and ethics review, specimen provenance, data integrity, and reporting. It is the IVD analogue of ISO 14155.
What this does not cover
stated in the document's own scope- Applies to IVD clinical performance studies using human specimens, not interventional device trials — see ISO 14155
- Does not cover bioanalytical assay validation for PK studies — see ICH M10
- Does not itself grant CE marking or regulatory approval
- Does not set analytical performance requirements for the IVD device design
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ISO 20916:2019 specifies good study practice for clinical performance studies of in vitro diagnostic (IVD) medical devices that use specimens from human subjects. It sets out principles for the ethical conduct, planning, design, conduct, monitoring, recording, and reporting of such studies, including the clinical performance study plan (CPSP), the roles and responsibilities of the sponsor and the principal investigator, informed consent and ethics review, specimen provenance and handling, data integrity, and deviation and safety reporting. It is the IVD analogue of ISO 14155 for clinical investigation of medical devices, adapted to studies performed on specimens rather than interventions on subjects.
Legal basis & how it acquires force
ISO 20916 is a voluntary international standard published by ISO; it is not law in itself. It acquires practical force where a regulator or a submission relies on it — notably supporting performance evaluation and clinical performance study requirements under the EU IVD Regulation (EU) 2017/746 — or where a sponsor adopts it as its good-study-practice basis. It interprets and operationalises general good clinical practice principles for the IVD context.
Document structure
| Part | Covers |
|---|---|
| Scope, terms, and general principles | Applicability, definitions, ethical and scientific principles |
| Clinical performance study planning | The clinical performance study plan (CPSP), design, and endpoints |
| Roles and responsibilities | Sponsor, principal investigator, and other parties |
| Conduct and monitoring | Specimen provenance/handling, consent, monitoring, data integrity |
| Reporting | Deviation/safety reporting and the clinical performance study report |
| Annexes | Informative guidance and templates supporting the requirements |
Key requirements
- Develop a clinical performance study plan (CPSP) defining objectives, design, and endpoints
- Obtain ethics committee/IRB review and, where applicable, subject informed consent
- Define sponsor and principal investigator roles and responsibilities
- Ensure specimen provenance, handling, and traceability are documented
- Maintain data integrity, source records, and monitoring appropriate to the study
- Manage and report study deviations and adverse events/incidents
- Prepare a clinical performance study report consistent with the plan
Implementation tips
- Treat ISO 20916 as the IVD analogue of ISO 14155 — IVD studies use specimens, not device interventions
- Align the CPSP with EU IVDR performance-evaluation expectations where the study supports a CE submission
- Address specimen consent and secondary-use provenance explicitly; it is a frequent gap in IVD studies
- Define acceptance criteria for clinical performance before enrollment, not after data are seen
International alignment
ISO 20916 is the IVD counterpart to ISO 14155 (clinical investigation of medical devices) and supports the clinical performance and performance-evaluation requirements of the EU IVDR (EU) 2017/746. It is consistent with the ICH E6 good clinical practice principles adapted to specimen-based studies.
ISO 20916:2019: frequently asked questions
Quick answers to common questions about ISO 20916:2019.
How does ISO 20916 relate to ISO 14155?
ISO 14155 covers clinical investigation of general medical devices; ISO 20916 is the parallel good-study-practice standard for IVD clinical performance studies using human specimens.
What is a CPSP?
The clinical performance study plan — the document defining the study objectives, design, endpoints, and conduct.
Which regulation does it support?
It supports the clinical performance study and performance-evaluation expectations of the EU IVD Regulation (EU) 2017/746.