EU Device Reclassification
This article was originally published in RAJ Devices
Executive Summary
Uncertainty over future of proposals
You may also be interested in...
Dr Reddy’s Knocked Back On Rituximab In US
Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.
Sandoz And Samsung Celebrate Stelara Rival’s EU Approval
Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.