
{"id":13181,"date":"2026-05-19T07:04:19","date_gmt":"2026-05-19T07:04:19","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/ce-isaretli-cihazin-veteriner-kullanimina-da-acilmasi-mdr-kapsaminda-degisiklik-midir\/"},"modified":"2026-05-19T07:04:19","modified_gmt":"2026-05-19T07:04:19","slug":"ce-isaretli-cihazin-veteriner-kullanimina-da-acilmasi-mdr-kapsaminda-degisiklik-midir","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/ce-isaretli-cihazin-veteriner-kullanimina-da-acilmasi-mdr-kapsaminda-degisiklik-midir\/","title":{"rendered":"CE i\u015faretli cihaz\u0131n veteriner kullan\u0131m\u0131na da a\u00e7\u0131lmas\u0131 MDR kapsam\u0131nda de\u011fi\u015fiklik midir?"},"content":{"rendered":"<p>Bu durumda karar, cihaz\u0131n piyasaya arz modeli, risk s\u0131n\u0131f\u0131, sertifika kapsam\u0131 ve \u00fcreticinin yapt\u0131\u011f\u0131 de\u011fi\u015fikli\u011fin etkisi \u00fczerinden verilmelidir. \u0130nsan kullan\u0131m\u0131 i\u00e7in belgelendirilen cihaz\u0131n veteriner kullan\u0131m\u0131 ayr\u0131 mevzuat ve ama\u00e7lanan kullan\u0131m a\u00e7\u0131s\u0131ndan de\u011ferlendirilmelidir. \u00dcretici, uygunluk beyan\u0131, sertifika, teknik dosya, etiket\/IFU ve kay\u0131t bilgilerini ayn\u0131 karar mant\u0131\u011f\u0131yla g\u00fcncellemelidir. \u00d6zellikle NB kapsam\u0131na giren cihazlarda de\u011fi\u015fiklik bildirim prosed\u00fcr\u00fc ve s\u00f6zle\u015fme \u015fartlar\u0131 ayr\u0131ca kontrol edilmelidir.<\/p>","protected":false},"excerpt":{"rendered":"<p>Bu durumda karar, cihaz\u0131n piyasaya arz modeli, risk s\u0131n\u0131f\u0131, sertifika kapsam\u0131 ve \u00fcreticinin yapt\u0131\u011f\u0131 de\u011fi\u015fikli\u011fin etkisi \u00fczerinden verilmelidir. \u0130nsan kullan\u0131m\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 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