• 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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    Surgeon at work in the OR
  • 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 equipment in hospital