
{"id":13223,"date":"2026-05-19T07:04:19","date_gmt":"2026-05-19T07:04:19","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/distributor-dfu-cevirisi-yaptiginda-mdr-madde-16-kapsamina-girer-mi\/"},"modified":"2026-05-19T07:04:19","modified_gmt":"2026-05-19T07:04:19","slug":"distributor-dfu-cevirisi-yaptiginda-mdr-madde-16-kapsamina-girer-mi","status":"publish","type":"kkqa_question","link":"http:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/distributor-dfu-cevirisi-yaptiginda-mdr-madde-16-kapsamina-girer-mi\/","title":{"rendered":"Distrib\u00fct\u00f6r DFU \u00e7evirisi yapt\u0131\u011f\u0131nda MDR Madde 16 kapsam\u0131na girer mi?"},"content":{"rendered":"<p>Bu soru ekonomik operat\u00f6r rol\u00fcn\u00fcn do\u011fru tan\u0131mlanmas\u0131na ba\u011fl\u0131d\u0131r. Distrib\u00fct\u00f6r\u00fcn \u00e7eviri yapmas\u0131 Madde 16 kapsam\u0131ndaki kalite sistemi, do\u011frulama ve \u00fcretici bilgilendirme y\u00fck\u00fcml\u00fcl\u00fcklerini do\u011furabilir. \u00dcretici, yetkili temsilci, ithalat\u00e7\u0131 ve distrib\u00fct\u00f6r rollerini s\u00f6zle\u015fme, etiket, kay\u0131t, \u015fikayet ve vigilance s\u00fcre\u00e7lerinde kar\u0131\u015ft\u0131rmamal\u0131d\u0131r. Denetimde beklenen yakla\u015f\u0131m; rol tan\u0131m\u0131, sorumluluk matrisi, ileti\u015fim prosed\u00fcr\u00fc ve kay\u0131tlar\u0131n izlenebilir \u015fekilde sunulmas\u0131d\u0131r.<\/p>","protected":false},"excerpt":{"rendered":"<p>Bu soru ekonomik operat\u00f6r rol\u00fcn\u00fcn do\u011fru tan\u0131mlanmas\u0131na ba\u011fl\u0131d\u0131r. Distrib\u00fct\u00f6r\u00fcn \u00e7eviri yapmas\u0131 Madde 16 kapsam\u0131ndaki kalite sistemi, do\u011frulama ve \u00fcretici bilgilendirme [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"kkqa_category":[505],"kkqa_letter":[468],"class_list":["post-13223","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-ekonomik-operatorler","kkqa_letter-d"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13223","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=13223"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13223\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13223"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13223"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13223"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}