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 also the MDR/IVDR Information.
