Article 120 kapsam\u0131ndaki legacy cihazlarda ge\u00e7i\u015f hakk\u0131 belirli \u015fartlara ba\u011fl\u0131d\u0131r. \u00d6nemli tasar\u0131m veya kullan\u0131m amac\u0131 de\u011fi\u015fikli\u011fi, sertifika ge\u00e7erlili\u011fi, onaylanm\u0131\u015f kurulu\u015f g\u00f6zetimi, PMS\/vigilance y\u00fck\u00fcml\u00fcl\u00fckleri ve EUDAMED\/UDI ge\u00e7i\u015f gereklilikleri birlikte incelenmelidir. \u00dcretici de\u011fi\u015fikli\u011fi, varyant ekleme veya tedarik\u00e7i de\u011fi\u015fikli\u011fi gibi konular ‘significant change’ a\u00e7\u0131s\u0131ndan yaz\u0131l\u0131 gerek\u00e7eyle de\u011ferlendirilmelidir. EUDAMED kayd\u0131 yap\u0131lacaksa akt\u00f6r rol\u00fc, SRN, Basic UDI-DI, UDI-DI, sertifika ve cihaz veri setleri \u00f6nceden tutarl\u0131 hale getirilmelidir. Firma \u00f6zelinde \u00fcr\u00fcn s\u0131n\u0131f\u0131, kullan\u0131m amac\u0131 ve pazar \u00fclkesi de\u011fi\u015fti\u011finde sonu\u00e7 de\u011fi\u015febilece\u011fi i\u00e7in karar kay\u0131t alt\u0131na al\u0131nm\u0131\u015f bir mevzuat de\u011ferlendirmesiyle desteklenmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
Article 120 kapsam\u0131ndaki legacy cihazlarda ge\u00e7i\u015f hakk\u0131 belirli \u015fartlara ba\u011fl\u0131d\u0131r. \u00d6nemli tasar\u0131m veya kullan\u0131m amac\u0131 de\u011fi\u015fikli\u011fi, sertifika ge\u00e7erlili\u011fi, onaylanm\u0131\u015f kurulu\u015f […]<\/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":[528],"kkqa_letter":[465],"class_list":["post-13591","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-gecis-hukumleri","kkqa_letter-a"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13591","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=13591"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13591\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13591"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13591"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13591"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}