Medical Devices Regulation (MDR) - Medical Devices Directive (MDD)

Medical devices manufactured or traded in the EU must comply with EU legislation in the area of safety and health. This means they have to be conform to the pertaining product directives and must be CE marked.

A new European legislation, the Medical Devices Regulation (MDR), will take effect per May 2021. The EU adopted the MDR following scandals caused by a number of medical device manufacturers.

For medical device manufacturers and Notified Bodies (NBs) the MDR is their number one concern. On this page we inform you about the MDD, the MDR and and what we can do for you in this area.

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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Medical Devices Regulation (MDR) - Medical Devices Directive (MDD)

EU finalizes 1-year MDR application delay

Medical Devices Directive

Medical Devices Regulation

Kiwa Notified Body for medical devices

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Medical Devices Regulation (MDR) - Medical Devices Directive (MDD)

EU finalizes 1-year MDR application delay

Medical Devices Directive

Medical Devices Regulation

Kiwa Notified Body for medical devices