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.
See all applications and CE related forms
See also the MDR/IVDR Information.
