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 26(3) and 28, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 25 and 26 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 on assessment of technical documentation X Conformity assessment based on type examination XI Conformity assessment based on production quality assurance XII Certificates issued by a notified body XIII Performance evaluation, performance studies and post-market performance follow-up XIV Interventional clinical performance studies and certain other performance studies XV Correlation table