Medical Device Regulation (MDR)

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.

New European legislation, the Medical Device Regulation (MDR), has taken 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. Read more in this section about the MDR and how we can help you with MDR certification.

Transition period for the MDR application extended

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

The Medical Devices Directive (MDD) has taken effect in 1993, and has been revised in 2010. The MDR (EU 2017/745) has replaced the MDD.
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Medical Devices Regulation

The Medical Device Regulation (MDR) has replaced the Medical Devices Directive (MDD). Kiwa Cermet Italia and Kiwa Dare Services have been designated as notified bodies for the MDR.
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Kiwa Notified Body for medical devices

Kiwa Italy, Kiwa Turkey and Kiwa Dare Services (Netherlands) 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 Device Regulation (MDR)

Transition period for the MDR application extended

Medical Devices Directive

Medical Devices Regulation

Kiwa Notified Body for medical devices

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Medical Device Regulation (MDR)

Transition period for the MDR application extended

Medical Devices Directive

Medical Devices Regulation

Kiwa Notified Body for medical devices