Whole EU Medtech Industry Behind Latest Push To Have MDR Problems Tackled At Highest Levels
The number of attempts to persuade EU decision-makers to take radical action to alleviate the MDR implementation pressures is growing exponentially as voices turn into a loud clamor for change.
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There are growing fears that the new EU medtech regulations could result in products used for children or rare diseases vanishing from the market. In an interview with Medtech Insight, regulatory expert Tom Melvin explains how these devices can be protected.
The call for more to be done about the EU’s regulatory hurdles to innovation, as well as for improvements to governance, has now grown to a crescendo. While the EU looks at how best to move forward, innovation in the UK is benefiting from greater regulatory freedoms.
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.