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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

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