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