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  • alexandrabuga replied to the topic "Classification in FDA Vs EU"5 years, 11 months ago

    Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found that in EU All implantable devices and long-term surgically invasive devices are in Class IIb…   Read more»