Official Sign-Off For EU Medical Device Regulation Amending Text Due Today
The first legal stages in the process for implementing new rules that will extend the Medical Device Regulation transitional period and remove the one-year sell-off period conditions are nearly complete. But further work will be needed.
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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.
EU Regulatory Round-Up, March 2023: EU Deadlines Under MDR Amending Regulation Published And Clarified
This month’s round-up summarises the biggest EU medtech regulatory news in a year as legacy device transition periods are extended. A highly applauded commission summary of the new timelines under the EU’s MDR amending regulation provides key snapshot of the essential points.