MDR de\u011ferlendirmesinde \u00fcr\u00fcn\u00fcn kullan\u0131m amac\u0131, hedef kullan\u0131c\u0131, iddia edilen klinik fayda ve cihaz s\u0131n\u0131f\u0131 birlikte ele al\u0131nmal\u0131d\u0131r. Madde veya ek bazl\u0131 bir h\u00fck\u00fcm tek ba\u015f\u0131na uygulanmaz; teknik dosya, risk y\u00f6netimi, PMS ve etiket bilgileriyle tutarl\u0131 olmal\u0131d\u0131r. \u00dcretici, ge\u00e7i\u015f h\u00fck\u00fcmleri, \u00f6nemli de\u011fi\u015fiklik, klinik de\u011ferlendirme ve uygunluk de\u011ferlendirme yolunu yaz\u0131l\u0131 bir karar kayd\u0131yla desteklemelidir. \u00d6zellikle Article 16, 22, 61, 117 ve 120 gibi maddelerde rol ve kapsam hatas\u0131 ciddi uygunsuzluk do\u011furabilir. Bu nedenle \u00fcretici, ticari karar ile reg\u00fclasyon karar\u0131n\u0131 ay\u0131rmal\u0131 ve karar mant\u0131\u011f\u0131n\u0131 yaz\u0131l\u0131 hale getirmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
MDR de\u011ferlendirmesinde \u00fcr\u00fcn\u00fcn kullan\u0131m amac\u0131, hedef kullan\u0131c\u0131, iddia edilen klinik fayda ve cihaz s\u0131n\u0131f\u0131 birlikte ele al\u0131nmal\u0131d\u0131r. Madde veya ek […]<\/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-13719","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-mdr","kkqa_letter-a"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13719","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=13719"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13719\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13719"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13719"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13719"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}