Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
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Conformity <strong>Assess</strong>ment: Steps to<br />
CE-Marking<br />
• Define intended use of the device<br />
• Classify the device<br />
• Choose a conformity assessment<br />
procedure<br />
• Set up <strong>and</strong> maintain the technical<br />
documentation including risk<br />
analysis<br />
• Perform conformity assessment (if<br />
required with <strong>Notified</strong> Body)<br />
• Issue the declaration of conformity<br />
<strong>and</strong> affix the CE marking