• Medical Devices Directive (MDD)

    The current Medical Devices Directive (MDD) has taken effect in 1993, and has been revised in 2010.

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  • Medical Devices Regulation (MDR)

    The Medical Devices Regulation (MDR) will replace the Medical Devices Directive (MDD) after a transitional period of three years in 2020.

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  • Kiwa Notified Body for medical devices

    Kiwa boasts a wide and in-depth experience as a Notified Body from over 20 years in medical devices certification, with thousands of products already certified.

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  • CE marking: what is a CE mark and when is it mandatory?

    CE marking is the confirmation that a medical device complies with the requirements of relevant European legislation.

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