Industry Voices Growing Frustration Over Notified Body Designations Despite Latest Listing
One more name has appeared in the European Commission list of notified bodies designated under the MDR and marks the the first time a Croatian company has been appointed. This time, the fanfare has been overshadowed by frustration from the industry as EU medtech regulation deadlines approach.
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The latest update in the Medical Device Regulation page of the European Commission's Nando database represents the 18th listing under the new regulation. Numbers are rising slowly.
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.