Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
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Role of the Manufacturer<br />
• The manufacturer has total responsibility for<br />
ensuring product complies with Medical<br />
Device Directives before CE-marking it <strong>and</strong><br />
placing it on the market<br />
• The manufacturer signs a Declaration of<br />
Conformity when:<br />
– Satisfied that the product meets Directives’<br />
requirements<br />
– Necessary conformity assessments are complete<br />
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