• EU finalizes 1-year MDR application delay

    Due to the COVID-19 outbreak, the EU has postphoned the date of application of the EU Medical Devices Regulation by one year. The Medical Devices Directives transitional period has also been extended.

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  • Medical Devices Directive

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

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  • Medical Devices Regulation

    The Medical Devices Regulation (MDR) will replace the Medical Devices Directive (MDD) after a transitional period in 2021.

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  • Kiwa Notified Body for medical devices

    Kiwa Italy and Kiwa Turkey boast a wide and in-depth experience as Notified Bodies in medical devices certification, with thousands of products already certified.

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