Kiwa Notified Body for Medical Devices

Within the Kiwa group, Kiwa Cermet Italia (NB 0476) and Kiwa Assurance B.V (Netherlands - NB 1912), operating under the name Kiwa Medical Certification boast a wide and in-depth experience as Notified Bodies in medical devices certification, with thousands of products already certified.

We assess whether medical devices meet the legally established requirements of the MDR. If the medical devices meet the requirements, they are CE marked and can enter the European market.

Kiwa Assurance B.V.

Kiwa has been appointed by the Dutch Ministry of Health, Welfare and Sport (VWS) as Notified Body for the Medical Devices Regulation (EU) 2017/745 (MDR). The designation is included in the Nando Database of the European Commission.

Kiwa is also accredited for testing in accordance with the standard for medical equipment, EN-IEC 60601, for both EMC and safety aspects.

Kiwa is member of TEAM-NB, the European Association Medical devices of Notified Bodies.