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.

Kiwa Dare, part of Kiwa since March 2021, is a Notified Body for MDR certification. Read more in this section about the MDR and how we can help you with MDR certification.

Medical Devices Regulation

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

Kiwa Dare is a Notified Body for medical devices. We assess whether medical devices meet the legally established requirements of the Medical Device Regulation (MDR).
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Medical Device Regulation (MDR)

Medical Devices Regulation

Medical Devices Directive

Kiwa Notified Body for medical devices

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Medical Device Regulation (MDR)

Medical Devices Regulation

Medical Devices Directive

Kiwa Notified Body for medical devices