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GLOSSARYEU

CE Mark

The marking by which a manufacturer indicates that a device conforms to the applicable requirements of the EU MDR and other Union harmonization legislation. Custom-made and investigational devices do not bear it.

Where it is written
Regulation (EU) 2017/745, Article 2(43); Article 20(1)
Also called
CE marking, CE marking of conformity

Avoid This Mistake

The CE marking is affixed before the device is placed on the market, not after.

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