Kiwa Notified Body for Medical Devices

Within the Kiwa group, Kiwa Cermet Italia (NB 0476) and Kiwa Belgelenddirme Hizmetleri in Turkey (NB 1984) boast a wide and in-depth experience as Notified Bodies in medical devices certification, with thousands of products already certified.

Kiwa Cermet Italia

Kiwa Cermet Italia has successfully achieved designation as a Notified Body by the Italian Ministry of Health and the European Commission for Conformity Assessment activities according to the Medical Device Regulation 2017/745/EU (MDR).

Kiwa Cermet Italia is able to deliver services related to CE mark for a wide range of medical devices, including also the highest risk class III, the device including medicinal products and the imaging device utilizing radiation, ensuring not only the continuity of EU market access for customers, but also the increase of service portfolio compared to the actual MDD designation.

Kiwa Cermet Italia is also a Certification Body accredited by ACCREDIA, according to the scheme ISO 13485.

Kiwa Turkey

Kiwa Turkey provides worldwide conformity assessment services as Notified Body with NB number 1984. Kiwa Turkey is an Accredited Body by TURKAK for Management System Certification according to ISO 9001 and ISO 13485 standards.

Member of TEAM-NB

Kiwa Cermet Italia and Kiwa Turkey are members of TEAM-NB, the European Association Medical devices of Notified Bodies.

For more information about our accreditations and notifications, please visit this page