European Commission Makes Final Decision On Cranberry Products
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.
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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.
The EU's medical device borderline and classification manual has just been updated for the second time this year. It contains seven new entries, including a few surprising ones.
The EU's manual on borderline products, where there is some ambiguity about whether medical device/IVD oversight applies, is set to be updated in line with the new Medical Devices and IVD Regulations. But in advance of that, the EU manual has been updated to provide guidance on 12 additional product types under the still-active Directive rules.