MDR\/IVDR AB pazar\u0131na ili\u015fkin temel \u00e7er\u00e7eveyi belirler; ancak dil, kay\u0131t, reklam, i\u015fletici sorumluluklar\u0131 veya ulusal bildirimler \u00fclke baz\u0131nda ayr\u0131ca ortaya \u00e7\u0131kabilir. T\u00fcrkiye i\u00e7in \u00dcTS kayd\u0131, belge e\u015fle\u015ftirme ve T\u0130TCK s\u00fcre\u00e7leri AB CE uygunlu\u011fundan ba\u011f\u0131ms\u0131z idari gereklilikler do\u011furabilir. \u00dcretici ve distrib\u00fct\u00f6r, her hedef pazar i\u00e7in etiket, IFU, ekonomik operat\u00f6r ve kay\u0131t gerekliliklerini ayr\u0131 kontrol etmelidir. EUDAMED kayd\u0131 yap\u0131lacaksa akt\u00f6r rol\u00fc, SRN, Basic UDI-DI, UDI-DI, sertifika ve cihaz veri setleri \u00f6nceden tutarl\u0131 hale getirilmelidir. Firma \u00f6zelinde \u00fcr\u00fcn s\u0131n\u0131f\u0131, kullan\u0131m amac\u0131 ve pazar \u00fclkesi de\u011fi\u015fti\u011finde sonu\u00e7 de\u011fi\u015febilece\u011fi i\u00e7in karar kay\u0131t alt\u0131na al\u0131nm\u0131\u015f bir mevzuat de\u011ferlendirmesiyle desteklenmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
MDR\/IVDR AB pazar\u0131na ili\u015fkin temel \u00e7er\u00e7eveyi belirler; ancak dil, kay\u0131t, reklam, i\u015fletici sorumluluklar\u0131 veya ulusal bildirimler \u00fclke baz\u0131nda ayr\u0131ca ortaya […]<\/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":[524],"kkqa_letter":[465],"class_list":["post-13475","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-uygulama-alani-ulusal-kurallar","kkqa_letter-a"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13475","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=13475"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13475\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13475"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13475"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13475"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}