Technical documentation on post-market surveillance
EU declaration of conformity
CE marking of conformity
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
Requirements to be met by notified bodies
Conformity assessment based on a quality management system and assessment of the technical documentation
Conformity assessment based on type examination
Conformity assessment based on product conformity verification
Certificates issued by a notified body
Procedure for custom-made devices
Clinical evaluation and post-market clinical follow-up
List of groups of products without an intended medical purpose referred to in Article 1(2)
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