<p><span lang="EN-GB">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.</span></p>
<p><span lang="EN-GB">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 </span>Annex I<span lang="EN-GB">).</span></p>
<p><span lang="EN-GB">This document specifies the general requirements intended to</span></p>
<ul>
<li><span lang="EN-GB">protect the rights, safety and well-being of human subjects, users or other persons,</span></li>
<li><span lang="EN-GB">ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,</span></li>
<li><span lang="EN-GB">define the responsibilities of the sponsor and principal investigator, and</span></li>
<li><span lang="EN-GB">assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.</span></li>
</ul>
<p><span lang="EN-GB">Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s).</span></p>
<p><span lang="EN-GB">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 </span>[5]<span lang="EN-GB">). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.</span></p>
<p><span lang="EN-GB">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, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.</span></p>
Registration number (WIID)
83968
Scope
<p><span lang="EN-GB">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.</span></p>
<p><span lang="EN-GB">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 </span>Annex I<span lang="EN-GB">).</span></p>
<p><span lang="EN-GB">This document specifies the general requirements intended to</span></p>
<ul>
<li><span lang="EN-GB">protect the rights, safety and well-being of human subjects, users or other persons,</span></li>
<li><span lang="EN-GB">ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,</span></li>
<li><span lang="EN-GB">define the responsibilities of the sponsor and principal investigator, and</span></li>
<li><span lang="EN-GB">assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.</span></li>
</ul>
<p><span lang="EN-GB">Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s).</span></p>
<p><span lang="EN-GB">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 </span>[5]<span lang="EN-GB">). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.</span></p>
<p><span lang="EN-GB">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, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.</span></p>
