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.
MDR Documents
MDR 2017/745 Class I: S, M and RS
MDR 2017/745 Class IIa and IIb Non-Implantable
MDR 2017/745 Class III and IIb Implantable
MDD/IVD Documents
CE Product Significant Change Notification and Review
Class 1 Substantial Change Application
Class IIa & IIb Non Implantable Substantial Change Application
Class IIb Implantable, Class III, AIMD Substantial Change Application
IVD Substantial Change Application
IVD 3 Year Renewal Application
Post Market Surveillance Application
