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.
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 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.
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).
Contact
Contact
If you have any questions about the Medical Device Regulation (MDR), please contact for more information Medical Devices, Kiwa Netherlands.
Cybersecurity in the healthcare sector
Do you want to know more about te cyber security possibilities in the healthcare sector?