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. Pratikte ilk yap\u0131lmas\u0131 gereken, ba\u015fl\u0131\u011f\u0131n yaln\u0131zca mevzuat maddesi olarak de\u011fil \u00fcr\u00fcn dosyas\u0131nda hangi kan\u0131tla desteklendi\u011fini kontrol etmektir.<\/p>","protected":false},"excerpt":{"rendered":"
MDR a\u00e7\u0131s\u0131ndan ana de\u011ferlendirme, \u00fcr\u00fcn\u00fcn kullan\u0131m amac\u0131, uygunluk de\u011ferlendirme yolu, ge\u00e7i\u015f h\u00fck\u00fcmleri ve teknik dosya kan\u0131tlar\u0131n\u0131n tutarl\u0131l\u0131\u011f\u0131d\u0131r.<\/p>","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-13783","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\/13783","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=13783"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13783\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13783"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13783"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}