CE mark is a legal requirement to place a medical device on the market anywhere within the European Union. In conjunction with ISO 13485 certification, this device specific evaluation supports a manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives that details the safety and performance requirements for medical devices. As a designated Notified Body under the Medical Device Directives, 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.
