
{"id":13629,"date":"2026-05-19T07:14:19","date_gmt":"2026-05-19T07:14:19","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/distributor-mdr-madde-14-kontrollerini-nasil-kayit-altina-almali\/"},"modified":"2026-07-16T11:49:55","modified_gmt":"2026-07-16T11:49:55","slug":"distributor-mdr-madde-14-kontrollerini-nasil-kayit-altina-almali","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/distributor-mdr-madde-14-kontrollerini-nasil-kayit-altina-almali\/","title":{"rendered":"Distrib\u00fct\u00f6r MDR Madde 14 kontrollerini nas\u0131l kay\u0131t alt\u0131na almal\u0131?"},"content":{"rendered":"<p>Distrib\u00fct\u00f6r, MDR Madde 14 kontrollerini \u00fcr\u00fcn kabul kontrol listesi, \u00f6rnekleme plan\u0131, CE-DoC-etiket do\u011frulama kayd\u0131, uygunsuz \u00fcr\u00fcn kayd\u0131 ve tedarik\u00e7i bazl\u0131 izlenebilirlik kay\u0131tlar\u0131yla g\u00f6stermelidir. Uygulamada \u00f6nce \u00fcr\u00fcn ve s\u00fcre\u00e7 s\u0131n\u0131r\u0131 netle\u015ftirilmelidir. Karar\u0131 etkileyen temel unsurlar yasal \u00fcretici, yetkili temsilci, ithalat\u00e7\u0131 ve distrib\u00fct\u00f6r rollerinin birbirinden ayr\u0131lmas\u0131; her rol\u00fcn kontrol ve kay\u0131t sorumlulu\u011fu olmal\u0131d\u0131r. Kurumsal kay\u0131t setinde rol ve sorumluluk prosed\u00fcr\u00fc, s\u00f6zle\u015fme\/mandat, CE-DoC kontrol listesi, \u00fcr\u00fcn kabul kayd\u0131, \u015fikayet-vijilans ileti\u015fim kayd\u0131, izlenebilirlik ve depolama kay\u0131tlar\u0131 birlikte g\u00f6sterilmelidir. Bu yakla\u015f\u0131m MDR ekonomik operat\u00f6r y\u00fck\u00fcml\u00fcl\u00fckleri, yetkili temsilci, ithalat\u00e7\u0131 ve distrib\u00fct\u00f6r sorumluluklar\u0131 ba\u015fl\u0131klar\u0131n\u0131n ayn\u0131 \u00fcr\u00fcn verisine dayanmas\u0131n\u0131 sa\u011flar. Gerek\u00e7e k\u0131sa tutulabilir; ancak \u00fcr\u00fcn \u00f6zelinde, g\u00fcncel ve do\u011frulanabilir olmas\u0131 gerekir.<\/p>","protected":false},"excerpt":{"rendered":"<p>Distrib\u00fct\u00f6r, MDR Madde 14 kontrollerini \u00fcr\u00fcn kabul kontrol listesi, \u00f6rnekleme plan\u0131, CE-DoC-etiket do\u011frulama kayd\u0131, uygunsuz \u00fcr\u00fcn kayd\u0131 ve tedarik\u00e7i bazl\u0131 [&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-13629","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-ekonomik-operatorler","kkqa_letter-d"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13629","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=13629"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13629\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13629"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13629"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13629"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}