EU Regulatory Watershed Sees Widely Diverging Expert Views Over MDR As They Bid Farewell To Directives
Today marks the end of an era. Directives that have defined our working days for decades will now recede into history. Some have spoken of their nostalgia, some of optimism, and others of concerns. For one regulatory veteran, meanwhile, EU medtech is heading in the wrong direction.
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Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.
Several manufacturers in the EU have marketed cranberry capsules as medical devices to gain regulatory and marketing advantages. Others have lobbied against this "unfair practice." France took the matter to the European Commission, which took action – the first time the commission employed its "borderline"-product designation authority.