EU Notified Bodies Told To Comply With Russia/Belarus Sanctions
Given the ongoing conflict in Ukraine, EU medtech notified bodies have been told to comply with sanctions intended to hurt companies based in Russia and Belarus.
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Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.
Medtech companies will soon be able to reference an updated European version of the international risk management standard when proving compliance with the EU Medical Device Regulation.