Before a medical device can be launched in the European Economic Area (EEA), it must receive a CE mark. The CE mark confirms that the medical device meets certain ‘essential requirements’ (i.e. that it is fit and safe for the intended purpose).

It also shows that the medical device can be freely marketed anywhere in the EEA without further control.

CE marking is mandatory, even if the medical device was manufactured outside the EEA. It is the manufacturer’s sole responsibility to obtain and place the CE mark on the product. If the product is imported from outside the . . .

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