<p>This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.</p>
<p>This document does not address language requirements since that is the domain of national laws and regulations.</p>
<p>This document does not apply to:</p>
<p>a) IVD medical devices for performance evaluation (e.g. for investigational use only);</p>
<p>b) shipping documents;</p>
<p>c) material safety data sheets / Safety Data Sheets;</p>
<p>d) marketing information (consistent with applicable legal requirements).</p>
<p>.</p>
Registration number (WIID)
79866
Scope
<p>This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.</p>
<p>This document does not address language requirements since that is the domain of national laws and regulations.</p>
<p>This document does not apply to:</p>
<p>a) IVD medical devices for performance evaluation (e.g. for investigational use only);</p>
<p>b) shipping documents;</p>
<p>c) material safety data sheets / Safety Data Sheets;</p>
<p>d) marketing information (consistent with applicable legal requirements).</p>
<p>.</p>
