Public Information
Certification Systems & Authorities
Kiwa Assurance B.V. operates under the authority of the Dutch Accreditation Council (ISO/IEC 17021-1) and the Ministry of Health, Welfare and Sport (NB MDR); Kiwa performs EN-ISO 13485 quality management system certifications under the ISO/IEC 17021-1 (see C637 scope).
The accreditation scope, under which Kiwa Assurance B.V. performs certification activities, can be found at the site of the RvA:
The scope of designation under which Kiwa performs MDR certification activities can be found in the Nando database of the European Union under NB 1912.
Kiwa has been designated as Notified Body to carry out conformity assessments according to the Regulation (EU) 2017/745 (MDR). If you require more information about the services, please let us know how we can be of assistance to you. Send an email to nl.medcert@kiwa.com or consult our webpage.