ISO 14155
ISO 14155 defines good clinical practice for clinical investigations of medical devices involving human subjects. It supports ethical study conduct, credible evidence, and clear sponsor and investigator responsibilities.
What is ISO 14155?
ISO 14155:2026 is the international good clinical practice standard for designing, conducting, recording, and reporting medical device clinical investigations involving human subjects. Its objectives include protecting participants’ rights, safety, and well-being; supporting scientifically sound research; and producing credible clinical evidence.
The standard also defines responsibilities for sponsors and principal investigators. Ethics committees, regulators, and conformity assessment bodies may use the resulting documentation when evaluating a device.
What is the current edition of ISO 14155?
The current edition is ISO 14155:2026, published in March 2026. It is the fourth edition and replaces the withdrawn 2020 edition. Clinical plans, procedures, templates, and supplier agreements should therefore be checked before citing ISO 14155:2020 in a new study.
Pure Global’s overview of the edition change is available in the ISO 14155:2026 update.
Does ISO 14155 apply to post-market studies and IVDs?
Its principles are intended to be followed as relevant for post-market clinical investigations, with the study design and device context taken into account. This makes the standard relevant to some post-market clinical follow-up activities.
ISO 14155 does not generally apply to in vitro diagnostic medical devices. However, particular provisions may still be considered when regional requirements or the nature of a study make them relevant.
Does following ISO 14155 guarantee regulatory approval?
No. ISO 14155 provides a recognized framework, but applicable laws, ethics requirements, and regulator expectations still control each investigation. Regulators can require additional evidence or jurisdiction-specific procedures.
For the European Union, clinical investigation results may feed the device’s Clinical Evaluation Report. U.S. sponsors should separately determine whether FDA investigational device requirements apply.
What should manufacturers align with ISO 14155?
Manufacturers should align the clinical investigation plan, informed-consent process, monitoring approach, data handling, safety reporting, investigator oversight, and final report. The study documentation should also connect the device’s intended purpose, risks, endpoints, and statistical rationale so the resulting evidence can support the intended regulatory use.
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