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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MDR Amending Regulation Officially Published And Already In Force
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.
Time For Talking: MedTech Europe Wants Clarity And Transparency Over MDR Amendment
The MDR amending regulation is on the cusp of being enforced. Most feel it is long overdue to prevent further medtech regulatory chaos in the EU. But the new text raises many questions itself. Medtech Insight spoke to MedTech Europe’s Petra Zoellner to understand what is needed next.
TEAM-NB Membership Increases By Over a Quarter Within Six Months
TEAM-NB was originally created to raise standards among notified bodies to an agreed harmonized level. Its latest expansion aims to continue that mission of spreading best conformity assessment practices.