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 2020. 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 and thus for Kiwa, as a Notified Body for medical devices. On this page we inform you about the MDD, the MDR and other important developments for the medical device industry regarding CE marking.

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 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

CE marking is the confirmation that a medical device complies with the requirements of relevant European legislation.
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Medical Devices Regulation (MDR) - Medical Devices Directive (MDD)

Medical Devices Directive

Medical Devices Regulation

Kiwa Notified Body for medical devices

CE marking

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

Medical Devices Directive

Medical Devices Regulation

Kiwa Notified Body for medical devices

CE marking