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Medical Device Regulation for non-medical products

Contact lenses, dermal fillers, machines for laser treatment for body hair removal… all products without medical purpose that will fall under the Medical Device Regulation as of 25 May 2020. The manufacturers must comply to the new regulation, but do they even know?

“Medical Device Regulation 2017/745”, the name suggests it applies to medical devices. But there is more to it. Annex XVI of the regulation clearly defines other devices, without medical purpose, that also must comply to the regulation. Products that may have been considered cosmetics in the past are now captured under the Medical Devices Regulation.