This document specifies good clinical practice (GCP) 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.

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For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see AnnexI).

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This document specifies the general requirements intended to

u000bu000bprotect the rights, safety and well-being of human subjects, users or other persons,u000bensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,u000bdefine the responsibilities of the sponsor and principal investigator, andu000bassist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.u000bu000b

Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s).

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NOTE For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference[5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.

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This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, whereusers of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.

Product Details

Published:

03/01/2026

File Size:

1 file , 3.6 MB

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus