Borderline and Classification Work Group â Introduction - TOPRA
Borderline and Classification Work Group â Introduction - TOPRA
Borderline and Classification Work Group â Introduction - TOPRA
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In conclusion<br />
• Who is on the <strong>Work</strong> <strong>Group</strong><br />
– Commission, Member State CAs, EMEA, Industry <strong>and</strong><br />
Notified Body representatives<br />
• The <strong>Work</strong> <strong>Group</strong> works on<br />
– MEDDEV 2.1/3 on demarcation between medical devices<br />
<strong>and</strong> drugs<br />
– Manual of Decisions<br />
• There are many products currently under discussion<br />
– Puts great pressure on participants<br />
• There is a path to follow to request a decision about a<br />
product<br />
The Organisation for Professionals in Regulatory Affairs<br />
17
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