Ek XVI \u00fcr\u00fcnlerinde t\u0131bbi ama\u00e7 bulunmamas\u0131 MDR d\u0131\u015f\u0131 anlam\u0131na gelmeyebilir. \u00dcr\u00fcn\u00fcn invazivli\u011fi, enerji uygulamas\u0131, insan dokusu ile temas\u0131, kullan\u0131c\u0131 riski ve ortak spesifikasyonlar\u0131n uygulanabilirli\u011fi de\u011ferlendirilmelidir. \u00dcretici pazarlama metinleri, etiket, IFU ve teknik dosyada ayn\u0131 kullan\u0131m amac\u0131 \u00e7izgisini korumal\u0131; estetik iddialar g\u00fcvenlik ve performans kan\u0131tlar\u0131yla desteklenmelidir. Klinik veri yeterlili\u011fi, risk-fayda sonucu ve pazarlama iddialar\u0131 aras\u0131nda izlenebilir ba\u011flant\u0131 kurulmal\u0131d\u0131r. 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":"
Ek XVI \u00fcr\u00fcnlerinde t\u0131bbi ama\u00e7 bulunmamas\u0131 MDR d\u0131\u015f\u0131 anlam\u0131na gelmeyebilir. \u00dcr\u00fcn\u00fcn invazivli\u011fi, enerji uygulamas\u0131, insan dokusu ile temas\u0131, kullan\u0131c\u0131 riski […]<\/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":[447],"kkqa_letter":[465],"class_list":["post-13408","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-mdr","kkqa_letter-a"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13408","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=13408"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13408\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13408"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13408"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13408"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}