Transition period for the MDR application extended
The current Medical Devices Directive (MDD) has taken effect in 1993, and has been revised in 2010.
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.
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.
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.
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.
The new regulations on medical devices
Read more about the regulatory framework on the EU website
Contact us
Are you located in Asia and Africa? Please contact Kiwa Turkey.