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<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>There is guidance or rationale for this Clause in </span>A.2.1<span lang="EN-GB">.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document specifies the requirements for <em style="mso-bidi-font-style: normal;">information supplied by the manufacturer</em> for a <em style="mso-bidi-font-style: normal;">medical device</em> or an <em style="mso-bidi-font-style: normal;">accessory</em>, as defined in </span>3.1<span lang="EN-GB">. This document includes the generally applicable requirements for identification and <em style="mso-bidi-font-style: normal;">labels</em> on a <em style="mso-bidi-font-style: normal;">medical device</em> or <em style="mso-bidi-font-style: normal;">accessory</em>, the packaging, <em style="mso-bidi-font-style: normal;">marking</em> of a <em style="mso-bidi-font-style: normal;">medical device</em> or <em style="mso-bidi-font-style: normal;">accessory,</em> and <em style="mso-bidi-font-style: normal;">accompanying information</em>. This document does not specify the means by which the information is to be supplied.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>Some <em style="mso-bidi-font-style: normal;">authorities having jurisdiction</em> impose different requirements for the identification, <em style="mso-bidi-font-style: normal;">marking</em> and documentation of a <em style="mso-bidi-font-style: normal;">medical device</em> or <em style="mso-bidi-font-style: normal;">accessory</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Specific requirements of <em style="mso-bidi-font-style: normal;">medical device product standards</em> or <em style="mso-bidi-font-style: normal;">group standards</em> take precedence over requirements of this document.</span></p>
Reģistrācijas numurs (WIID)
88714
Darbības sfēra
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>There is guidance or rationale for this Clause in </span>A.2.1<span lang="EN-GB">.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document specifies the requirements for <em style="mso-bidi-font-style: normal;">information supplied by the manufacturer</em> for a <em style="mso-bidi-font-style: normal;">medical device</em> or an <em style="mso-bidi-font-style: normal;">accessory</em>, as defined in </span>3.1<span lang="EN-GB">. This document includes the generally applicable requirements for identification and <em style="mso-bidi-font-style: normal;">labels</em> on a <em style="mso-bidi-font-style: normal;">medical device</em> or <em style="mso-bidi-font-style: normal;">accessory</em>, the packaging, <em style="mso-bidi-font-style: normal;">marking</em> of a <em style="mso-bidi-font-style: normal;">medical device</em> or <em style="mso-bidi-font-style: normal;">accessory,</em> and <em style="mso-bidi-font-style: normal;">accompanying information</em>. This document does not specify the means by which the information is to be supplied.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>Some <em style="mso-bidi-font-style: normal;">authorities having jurisdiction</em> impose different requirements for the identification, <em style="mso-bidi-font-style: normal;">marking</em> and documentation of a <em style="mso-bidi-font-style: normal;">medical device</em> or <em style="mso-bidi-font-style: normal;">accessory</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Specific requirements of <em style="mso-bidi-font-style: normal;">medical device product standards</em> or <em style="mso-bidi-font-style: normal;">group standards</em> take precedence over requirements of this document.</span></p>
