Fruitful Use Of EU Reg Loopholes Or Farce? How The Cranberry Is Dividing Opinions
This article was originally published in Clinica
The borders between medical devices, pharmaceuticals and even nutraceuticals are so fine that many companies seek to cross these subtle lines in order to gain regulatory or marketing advantage over their competitors. Often, this is achieved with success – although sometimes on shaky ground.
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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.
Challenges will persist for borderline and combination products under the new EU regulatory structure so manufacturers need to continue to pay close attention when determining the classification of these products.
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.