Medtech Experts Voice Mixed Reactions To European Commission's New MDR Proposals
Many well respected medtech experts have taken to LinkedIn to voice their opinions on the European Commission’s proposals to address the growing challenges with the implementation of the MDR. A glance at their views shows just how split opinions are.
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The European Commission is now a step closer to implementing legislation that will see staggered delays for the application of the MDR in a bid to forestall medical devices shortages across the EU, with even longer extensions proposed than previously expected.
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Another key stage has been reached in Switzerland’s bid to enable US FDA-approved medtech to be used in the local population.
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A first of its kind study examines how large compared with medium companies are coping with the EU’s strict clinical evidence requirements. The results show how it is the more stringent demands for high-risk devices that are leading to device removals as well as market launch outside the EU.