Borderline and Classification Work Group â Introduction - TOPRA
Borderline and Classification Work Group â Introduction - TOPRA
Borderline and Classification Work Group â Introduction - TOPRA
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Manual of Decisions<br />
• Debates issues about<br />
– <strong>Borderline</strong>s<br />
• Is it a medical device? If not why not?<br />
– <strong>Classification</strong>s<br />
• If it is a device, what class is it?<br />
– Results are in a “Manual of Decisions”<br />
• http://ec.europa.eu/enterprise/medical_devices/borderline_class<br />
ification_en.htm<br />
• A very useful document<br />
– Its potential benefits well outweigh any risks<br />
– Need Member States to follow it<br />
The Organisation for Professionals in Regulatory Affairs<br />
7
Change language