Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
What do <strong>Notified</strong> <strong>Bodies</strong> do?<br />
• <strong>Assess</strong> the conformity of products to the Essential<br />
Requirements of the Medical Device Directives<br />
<strong>and</strong> the Quality Systems used to manufacture<br />
them to relevant st<strong>and</strong>ards<br />
– This enables manufacturers to affix the CE mark to<br />
the product <strong>and</strong> gain entry to the EU market<br />
• <strong>Notified</strong> Body involvement increases with the risk<br />
of product<br />
– For high risk products, <strong>Notified</strong> <strong>Bodies</strong> need very<br />
significant <strong>and</strong> varied expertise<br />
• Manufacturers need expert <strong>and</strong> stable <strong>Notified</strong><br />
<strong>Bodies</strong> to provide secure long term market access<br />
6
Change language