
{"id":13787,"date":"2026-05-19T07:14:21","date_gmt":"2026-05-19T07:14:21","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/mdr-altinda-klinik-arastirma-yapmadan-ce-almak-mumkun-mu\/"},"modified":"2026-07-16T12:18:53","modified_gmt":"2026-07-16T12:18:53","slug":"mdr-altinda-klinik-arastirma-yapmadan-ce-almak-mumkun-mu","status":"publish","type":"kkqa_question","link":"http:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/mdr-altinda-klinik-arastirma-yapmadan-ce-almak-mumkun-mu\/","title":{"rendered":"MDR alt\u0131nda klinik ara\u015ft\u0131rma yapmadan CE almak m\u00fcmk\u00fcn m\u00fc?"},"content":{"rendered":"<p>Klinik de\u011ferlendirme, \u00fcr\u00fcn\u00fcn iddia edilen g\u00fcvenlilik ve performans\u0131n\u0131 klinik verilerle destekleyen sistematik bir s\u00fcre\u00e7tir. D\u00fc\u015f\u00fck riskli \u00fcr\u00fcnlerde dahi kullan\u0131m amac\u0131, benzer \u00fcr\u00fcn deneyimi, literat\u00fcr, PMS verisi ve risk profili ile klinik gerek\u00e7e olu\u015fturulmal\u0131d\u0131r. CER i\u00e7inde klinik iddialar, kabul kriterleri, literat\u00fcr stratejisi, e\u015fde\u011ferlik gerek\u00e7esi, veri bo\u015fluklar\u0131 ve PMCF ihtiyac\u0131 a\u00e7\u0131k\u00e7a tart\u0131\u015f\u0131lmal\u0131d\u0131r. Sadece literat\u00fcr eklemek yeterli de\u011fildir; literat\u00fcr\u00fcn \u00fcr\u00fcne neden uygulanabilir oldu\u011fu a\u00e7\u0131klanmal\u0131d\u0131r. 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":"<p>Klinik de\u011ferlendirme, \u00fcr\u00fcn\u00fcn iddia edilen performans\u0131 ve klinik faydas\u0131 i\u00e7in yeterli klinik kan\u0131t\u0131n sistematik \u015fekilde g\u00f6sterilmesidir.<\/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":[455],"kkqa_letter":[467],"class_list":["post-13787","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-klinik-degerlendirme","kkqa_letter-c"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13787","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=13787"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13787\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13787"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13787"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13787"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}