ISO 14155 Clinical Research of Medical Devices for Human Subjects - Good Clinical Practice

This standard addresses good clinical practices for the design, conduct, recording and reporting of clinical trials conducted in human subjects to evaluate the clinical performance or efficacy and safety of medical devices. For post-marketing clinical trials, the principles set out in this standard are intended to be followed to the extent relevant, taking into account the nature of the clinical investigation.

This standard specifies the general requirements intended:

• To protect the rights, safety and well-being of human subjects;
• To ensure the scientific conduct of clinical research and the reliability of clinical research results;
• Define the responsibilities of the sponsor and principal investigator;
• Assisting sponsors, researchers, ethics committees, regulatory authorities and other organizations involved in the conformity assessment of medical devices.

This standard does not apply to in vitro diagnostic medical devices. However, depending on the device and national or regional requirements, there may be situations where users of this standard may evaluate whether certain parts or requirements of this standard are applicable.

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