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Valid from 10.10.2026

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ISO 14155 specifies good clinical practice for clinical investigations of medical devices involving human subjects. It covers the design, conduct, recording and reporting of investigations used to assess a device’s clinical performance, effectiveness and safety. ISO 14155 guidelines provide the requirements for clinical investigations 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.
• Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.