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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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.
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.
The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.