<p>NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.</p>
<p>This document specifies the requirements for <em>information supplied by the manufacturer</em> for a <em>medical device</em> or by the<em> manufacturer</em> for an <em>accessory</em>, as defined in 3.1. This document includes the generally applicable requirements for identification and <em>labels</em> on a <em>medical device</em> or <em>accessory</em>, the packaging, <em>marking</em> of a <em>medical device</em> or <em>accessory,</em> and <em>accompanying information</em>. This document does not specify the means by which the information is to be supplied.</p>
<p>NOTE 2 Some <em>authorities having jurisdiction</em> impose different requirements for the identification, <em>marking</em> and documentation of a <em>medical device</em> or <em>accessory</em>.</p>
<p>Specific requirements of <em>medical device</em> <em>product standards</em> or<em> group standards</em> take precedence over requirements of this document.</p>
Registration number (WIID)
88714
Scope
<p>NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.</p>
<p>This document specifies the requirements for <em>information supplied by the manufacturer</em> for a <em>medical device</em> or by the<em> manufacturer</em> for an <em>accessory</em>, as defined in 3.1. This document includes the generally applicable requirements for identification and <em>labels</em> on a <em>medical device</em> or <em>accessory</em>, the packaging, <em>marking</em> of a <em>medical device</em> or <em>accessory,</em> and <em>accompanying information</em>. This document does not specify the means by which the information is to be supplied.</p>
<p>NOTE 2 Some <em>authorities having jurisdiction</em> impose different requirements for the identification, <em>marking</em> and documentation of a <em>medical device</em> or <em>accessory</em>.</p>
<p>Specific requirements of <em>medical device</em> <em>product standards</em> or<em> group standards</em> take precedence over requirements of this document.</p>
