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.
Class 1 Substantial Change Application
New Class IIa & IIb Non Implantable Application
Class IIa & IIb Non Implantable Substantial Change Application
New Class IIb Implantable, Class III, AIMD Application
Class IIb Implantable, Class III, AIMD Substantial Change Application
All MDD/AIMD 3 Year Renewal Application
IVD Substantial Change Application
IVD 3 Year Renewal Application
Post Market Surveillance Application
