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