IVDR de\u011ferlendirmesinde intended purpose, test edilen analit, numune tipi, kullan\u0131c\u0131 profili, sonu\u00e7lar\u0131n klinik karar \u00fczerindeki etkisi ve s\u0131n\u0131fland\u0131rma kural\u0131 birlikte incelenmelidir. RUO, self-test, companion diagnostic veya near-patient test gibi ifadeler \u00fcr\u00fcn\u00fcn y\u00fck\u00fcml\u00fcl\u00fcklerini ciddi \u015fekilde etkileyebilir. Performans de\u011ferlendirme dosyas\u0131nda bilimsel ge\u00e7erlilik, analitik performans ve klinik performans ayr\u0131 ayr\u0131 g\u00f6sterilmelidir. Legacy cihazlar i\u00e7in ge\u00e7i\u015f h\u00fck\u00fcmleri olsa bile PMS, vigilance ve kalite sistemi y\u00fck\u00fcml\u00fcl\u00fckleri devam eder; bu nedenle dosya yaln\u0131zca eski IVDD mant\u0131\u011f\u0131yla b\u0131rak\u0131lmamal\u0131d\u0131r. Dosyada ayn\u0131 bilgi etiket, IFU, risk analizi, GSPR matrisi ve uygunluk beyan\u0131nda tutarl\u0131 g\u00f6r\u00fcnmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
IVDR a\u00e7\u0131s\u0131ndan cevap, intended purpose, s\u0131n\u0131fland\u0131rma, performans de\u011ferlendirme, ge\u00e7i\u015f h\u00fck\u00fcmleri ve ekonomik operat\u00f6r rol\u00fcne g\u00f6re belirlenir.<\/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":[448],"kkqa_letter":[481],"class_list":["post-13806","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-ivdr","kkqa_letter-r"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13806","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=13806"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13806\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13806"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13806"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13806"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}