Medical Device Regulation

European Market Access Medical Devices

Prior to launching a product on the European market it must comply with all applicable requirements in European legislation. The CE (Conformité Européene) marking is the manufacturer’s declaration that a product fulfills relevant regulations and standards, including safety, health and environmental protection requirements. All medical devices marketed within the borders of the European Economic Area must fulfil the requirements set out in the Medical Device Regulation (MDR), proving safety and performance, in order to affix the CE mark.

If you are interested in having devices certified under the MDR by DEKRA, a pre-application is first required. For further information, please contact us from info.japan@dekra.com .

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DEKRA Japan

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