{"id":6533,"date":"2023-03-12T04:55:14","date_gmt":"2023-03-12T01:55:14","guid":{"rendered":"https:\/\/www.katsanas.com\/?p=6533"},"modified":"2025-07-30T12:18:07","modified_gmt":"2025-07-30T12:18:07","slug":"eudamede-hazir-misiniz","status":"publish","type":"post","link":"https:\/\/www.katsanas.com\/en\/eudamede-hazir-misiniz\/","title":{"rendered":"EUDAMED&#8217;e Haz\u0131r m\u0131s\u0131n\u0131z?"},"content":{"rendered":"<h4><strong><a href=\"https:\/\/katsanas.com\/\">Home \u00bb \u00a0 \u00a0 <\/a><a href=\"https:\/\/www.katsanas.com\/blog-katsan\/\">Blog \u00bb \u00a0 \u00a0 <\/a>EUDAMED&#8217;e Haz\u0131r m\u0131s\u0131n\u0131z? \u00bb \u00a0 \u00a0 <\/strong><\/h4>\n<div class=\"row\">\n<div class=\"col-md-5\"><img decoding=\"async\" class=\"aligncenter wp-image-5861\" src=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/10\/MDR-4.png\" alt=\"\" \/><\/div>\n<div class=\"col-md-7\">\n<p><img decoding=\"async\" style=\"width: 100%;\" src=\"v\" alt=\"\" \/><\/p>\n<p>EUDAMED, Avrupa Birli\u011fi i\u00e7erisinde dola\u015f\u0131mda olan her t\u0131bbi cihaz i\u00e7in \u201ccanl\u0131 bir veri taban\u0131\u201d olarak vazife g\u00f6rmeyi ama\u00e7lad\u0131\u011f\u0131 i\u00e7in MDR&#8217;nin en kritik y\u00f6nlerinden biridir. EUDAMED \u015fu an tamamen i\u015flevsel olmasa da, \u00fcreticiler planlar\u0131n\u0131 onun ka\u00e7\u0131n\u0131lmaz geli\u015fine y\u00f6nelik yapmal\u0131d\u0131r.<\/p>\n<p>MDCG belgeleri, \u00fcreticileri sistemin pratik kullan\u0131m\u0131na haz\u0131rlamak i\u00e7in yeterli olmayabilir. Bu nedenle EUDAMED BETA, EUDAMED sistemi ile ilgili teknik ve rehber dok\u00fcmanlar\u0131n sa\u011flanmas\u0131 amac\u0131yla kullan\u0131ma sunulmu\u015ftur. Ayr\u0131ca, bu b\u00f6l\u00fcm EUDAMED i\u00e7in bir \u201coyun alan\u0131na\u201d da eri\u015fim sa\u011flamaktad\u0131r.<\/p>\n<p>Bu oyun alan\u0131, kullan\u0131c\u0131lar\u0131n EUDAMED sisteminde, ger\u00e7ek sisteme herhangi bir etkisi olmadan, kendi \u015firket bilgileriyle \u201coynamalar\u0131na\u201d izin veren bir portald\u0131r. Bu sistem, \u00fcreticilerin sistemden etkin bir \u015fekilde yararlanabilmeleri i\u00e7in eksikliklerini belirlemelerine ve sistemin uygulamaya al\u0131naca\u011f\u0131 zaman i\u00e7in plan yapmalar\u0131na olanak tan\u0131maktad\u0131r.<\/p>\n<p>EUDAMED i\u00e7in mevcut zaman \u00e7izelgesi 6 ad\u0131mdan olu\u015fmaktad\u0131r ve bunlar\u0131n en \u00f6nemlisi, EUDAMED&#8217;in 6 mod\u00fcl\u00fcn\u00fcn (Akt\u00f6rler, Tetikte Olma, Klinik Ara\u015ft\u0131rma ve Performans \u00c7al\u0131\u015fmalar\u0131 ve Piyasa G\u00f6zetim mod\u00fclleri) tamam\u0131n\u0131n devreye al\u0131nmas\u0131 i\u00e7in son tarih olan ve o tarih itibari ile kullan\u0131lmas\u0131n\u0131 zorunlu k\u0131lan 2024 4. \u00c7eyrektir. Di\u011fer \u00f6nemli zaman aral\u0131\u011f\u0131 ise di\u011fer mod\u00fcllerin, UDI\/Cihaz ve NB &amp; Sertifika, mod\u00fcllerinin kullan\u0131m\u0131n\u0131n zorunlu hale getirilmesi i\u00e7in son tarih olan 2026 Q2&#8217;dir.<\/p>\n<p>EUDAMED&#8217;in amac\u0131 bir canl\u0131 veri taban\u0131 olu\u015fturmak oldu\u011fundan, \u00fcreticilerden cihazlar\u0131yla ilgili s\u00fcrekli veri g\u00fcncellemeleri istenecektir. Bu nedenle, geli\u015ftirme s\u00fcresi, \u00fcreticilerin belge ve yaz\u0131l\u0131m entegrasyonu haz\u0131rl\u0131k seviyelerini art\u0131rmak i\u00e7in kullan\u0131lmal\u0131d\u0131r.<\/p>\n<\/div>\n<\/div>\n<div id=\"51BA82CA_4C9C_0457_CE97_0423ED0CEB6D\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>EUDAMED, Avrupa Birli\u011fi i\u00e7erisinde dola\u015f\u0131mda olan her t\u0131bbi cihaz i\u00e7in \u201ccanl\u0131 bir veri taban\u0131\u201d olarak<br \/>\nvazife g\u00f6rmeyi ama\u00e7lad\u0131\u011f\u0131<\/p>\n","protected":false},"author":2,"featured_media":6511,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[],"class_list":["post-6533","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-tr"],"_links":{"self":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts\/6533","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/comments?post=6533"}],"version-history":[{"count":2,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts\/6533\/revisions"}],"predecessor-version":[{"id":14416,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts\/6533\/revisions\/14416"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/media\/6511"}],"wp:attachment":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/media?parent=6533"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/categories?post=6533"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/tags?post=6533"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}