Module 18 - Drug Device Combinations and Other Technologies

What is a cosmetic product?

“Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity

with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;”

- from Cosmetic Products Regulation (EU) 1223/2009

In short, it’s for cosmetic purposes – keeping things clean, maintaining condition, or making them look or smell better.

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Borderlines with Cosmetics

Whether a product is a cosmetic or a medical device will relate mainly to the claims made for it. The majority of borderlines of this nature are between medicinal products and cosmetics, rather than medical devices, and will centre on whether there are ‘medicinal’ claims for the product concerned. There are, however, a few products on the borderline with medical devices: e.g.

Hair conditioner – cosmetic Hair product intended to aid the removal of lice with a head lice comb – accessory to the medical device (comb) and therefore a medical device.

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