CE mark is a legal requirement to place a medical device on the market within the European Union. In conjunction with EN ISO 13485 certification, this device specific evaluation supports a manufacturer’s claim that a product is compliant to the European Medical Device Regulation that details the safety and performance requirements for medical devices. As a designated Notified Body under the MDR, NSAI has the technical expertise and experience to provide the applicable CE marking services.
NSAI is now able to provide conformity assessments under the IVDR and grant CE marked certificates to the scope documented on the NANDO database. NSAI will be performing conformity assessment activities under IVDR 2017/746, Annex IX Chapter I and Chapter II.
The Designation represents a significant expansion in the scope of conformity assessment provided under the old IVDD. In line with this expansion, NSAI is designated to perform conformity assessment activities for all Classifications of devices: Class A, Class B, Class C and Class D.
See also the MDR/IVDR Information.