<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">This document specifies principles and a process for the clinical evaluation of medical devices. The process describes planning and performing clinical evaluations. It covers the collection, appraisal and analysis of evidence derived from clinical and where relevant, non-clinical data, to assess and verify the safety and performance or effectiveness including clinical benefit(s) of the device under evaluation (DUE). </span></p>
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">This document also:</span></p>
<ul>
<li style="list-style-type: none;">
<ul>
<li class="ListContinue1"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">establishes the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation on behalf of the manufacturer;</span></li>
<li class="ListContinue1"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;"><span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">provides manufacturers with a framework within which to conduct the clinical evaluation of medical devices;</span></li>
<li class="ListContinue1"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">provides guidance on the scientific conduct of a clinical evaluation, thereby supporting the credibility of conclusions.</span></li>
</ul>
</li>
</ul>
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">Not all requirements of this document apply to each device type or medical device life cycle phase.</span></p>
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">While other parties can contribute to the clinical evaluation process, the responsibility and accountability remain with the manufacturer.</span></p>
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span style="font-size: 11.0pt; mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: DE; mso-fareast-language: DE; mso-bidi-language: AR-SA;">This document does not apply to in vitro diagnostic medical devices.</span></p>
Registration number (WIID)
85514
Scope
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">This document specifies principles and a process for the clinical evaluation of medical devices. The process describes planning and performing clinical evaluations. It covers the collection, appraisal and analysis of evidence derived from clinical and where relevant, non-clinical data, to assess and verify the safety and performance or effectiveness including clinical benefit(s) of the device under evaluation (DUE). </span></p>
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">This document also:</span></p>
<ul>
<li style="list-style-type: none;">
<ul>
<li class="ListContinue1"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">establishes the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation on behalf of the manufacturer;</span></li>
<li class="ListContinue1"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;"><span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">provides manufacturers with a framework within which to conduct the clinical evaluation of medical devices;</span></li>
<li class="ListContinue1"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">provides guidance on the scientific conduct of a clinical evaluation, thereby supporting the credibility of conclusions.</span></li>
</ul>
</li>
</ul>
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">Not all requirements of this document apply to each device type or medical device life cycle phase.</span></p>
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif;">While other parties can contribute to the clinical evaluation process, the responsibility and accountability remain with the manufacturer.</span></p>
<p class="MsoBodyText" style="margin-left: 35.45pt; mso-layout-grid-align: none; text-autospace: none;"><span style="font-size: 11.0pt; mso-bidi-font-size: 12.0pt; font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: DE; mso-fareast-language: DE; mso-bidi-language: AR-SA;">This document does not apply to in vitro diagnostic medical devices.</span></p>
