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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 Routes<br />

• If a product complies with the requirements of a new<br />

approach directive, the manufacturer signs a<br />

conformity declaration.<br />

• Depending on the potential risk of the device<br />

certification by a <strong>Notified</strong> Body may be required.<br />

• If certification is a requirement as part of the<br />

conformity assessment procedure, the manufacturer<br />

has the option to choose any of the <strong>Notified</strong> <strong>Bodies</strong> in<br />

any of the Member States of the EU.<br />

• Products which require certification by a <strong>Notified</strong> Body<br />

carry the CE-marking in combination with the number<br />

of the <strong>Notified</strong> Body, for example:

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