ISO 14155 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this standard are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
ISO 14155 specifies general requirements intended to
— protect the rights, safety and well-being of human subjects,
— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
— define the responsibilities of the sponsor and principal investigator, and
— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Users of this standard need to consider whether other standards or national requirements also apply to the investigational devices under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.
For Software as a medical device (SaMD) demonstration of the analytical validity, and where appropriate, the scientific validity, and clinical performance of the SaMD, the requirements of this document apply as far as relevant. Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
ISO 14155 does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this standard might consider whether specific sections or requirements of ISO 14155 could apply.
ISO 14155:2026 text has been approved in Europe as EN ISO 14155:2026 without any changes.
