ANNEXESSupplementary provisions
ANNEXES I General safety and performance requirements II Technical documentation III Technical documentation on post-market surveillance IV EU declaration of conformity V CE marking of conformity VI Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the UDI system VII Requirements to be met by notified bodies VIII Classification rules IX Conformity assessment based on a quality management system and assessment of the technical documentation X Conformity assessment based on type examination XI Conformity assessment based on product conformity verification XII Certificates issued by a notified body XIII Procedure for custom-made devices XIV Clinical evaluation and post-market clinical follow-up XV Clinical investigations XVI List of groups of products without an intended medical purpose referred to in Article 1(2) XVII Correlation table