{"id":16405,"date":"2026-07-16T11:03:51","date_gmt":"2026-07-16T11:03:51","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/mdr-article-61-kapsaminda-class-i-urunlerde-klinik-degerlendirme-gerekir-mi\/"},"modified":"2026-07-16T12:14:36","modified_gmt":"2026-07-16T12:14:36","slug":"mdr-article-61-kapsaminda-class-i-urunlerde-klinik-degerlendirme-gerekir-mi","status":"publish","type":"kkqa_question","link":"http:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/mdr-article-61-kapsaminda-class-i-urunlerde-klinik-degerlendirme-gerekir-mi\/","title":{"rendered":"MDR Article 61 kapsam\u0131nda Class I \u00fcr\u00fcnlerde klinik de\u011ferlendirme gerekir mi?"},"content":{"rendered":"<p>Class I \u00fcr\u00fcnlerde de g\u00fcvenlilik ve performans iddialar\u0131 klinik veri, literat\u00fcr, e\u015fde\u011fer \u00fcr\u00fcn bilgisi, PMS verisi veya gerek\u00e7eli teknik de\u011ferlendirme ile desteklenmelidir. Sadece \u00fcr\u00fcn d\u00fc\u015f\u00fck riskli diye klinik de\u011ferlendirme tamamen atlanmamal\u0131d\u0131r.<\/p>","protected":false},"excerpt":{"rendered":"<p>Evet. Klinik de\u011ferlendirme yaln\u0131zca y\u00fcksek riskli cihazlara ait bir y\u00fck\u00fcml\u00fcl\u00fck de\u011fildir.<\/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":[465],"class_list":["post-16405","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-klinik-degerlendirme","kkqa_letter-a"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/16405","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=16405"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/16405\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=16405"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=16405"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=16405"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}