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        amendement and the UDI system annex ANNEX I ANNEX I - General Safety and performance requirements ANNEX VI assessment assessment procedure authorities CE CE marking certificate Chapter I Chapter II Chapter III clinical clinical evaluation clinical investigation clinical investigations conformity conformity assessment core data elements to be provided to the UDI database together with the UDI-DI in accordance with articles 28 and 29 designation electronic electronic system evaluation general requirements general safety General Safety and performance requirements importers market mdr notified bodies performance requirements post-market post-market surveillance procedure registration requirements review safety technical documentation UDI UDI database UDI system

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