{"id":57,"date":"2024-02-20T16:12:34","date_gmt":"2024-02-20T13:12:34","guid":{"rendered":"https:\/\/medses.org\/?p=57"},"modified":"2024-02-23T17:48:56","modified_gmt":"2024-02-23T14:48:56","slug":"onaylanmis-kurulus-beyani-onaylanmis-kurulus-onay-mektubu-nedir","status":"publish","type":"post","link":"https:\/\/medses.org\/?p=57","title":{"rendered":"Onaylanm\u0131\u015f Kurulu\u015f Beyan\u0131 (Onaylanm\u0131\u015f Kurulu\u015f Onay Mektubu) Nedir?"},"content":{"rendered":"\n<p class=\"has-black-color has-text-color has-link-color wp-elements-af88cab362d4d9055f81014f8c89492b wp-block-paragraph\">Onaylanm\u0131\u015f Kurulu\u015f Beyan\u0131; s\u00fcre uzat\u0131m\u0131 s\u00fcrecinde \u00fcreticinin onaylanm\u0131\u015f kurulu\u015ftan, ba\u015fvuru yap\u0131lan cihaz veya cihazlar\u0131n s\u00fcre uzat\u0131m\u0131 i\u00e7in gerekli ko\u015fullar\u0131 ta\u015f\u0131d\u0131\u011f\u0131na dair ald\u0131\u011f\u0131 bir beyand\u0131r. Bu belgede bulunmas\u0131 gereken asgari ko\u015fullar ise T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu &#8216;nun 2023\/KK-1 duyurusu adl\u0131 duyurusunun Ek-2 sinde belirtilmi\u015ftir. Bu ko\u015fullar\u0131n ne oldu\u011fu a\u015fa\u011f\u0131da verilmi\u015ftir ayr\u0131ca s\u00f6z konusu belgeye ait \u015fablona eri\u015fmek i\u00e7in <a href=\"https:\/\/medses.org\/wp-content\/uploads\/2024\/02\/md_confirmation-letter-2023-607-nbcg-tr.docx\">buraya<\/a> t\u0131klayabilirsiniz.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-def4b71be72deef8610da17ca53720ca wp-block-paragraph\" style=\"font-size:20px\"><strong>Onaylanm\u0131\u015f Kurulu\u015f Beyan\u0131nda asgari bulunmas\u0131 gerekenler<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-a2fa859cc819e7daa545b7916bcde23c wp-block-paragraph\">1- \u0130malat\u00e7\u0131n\u0131n uygunluk de\u011ferlendirmesi ba\u015fvurusunun ilgili onaylanm\u0131\u015f kurulu\u015f taraf\u0131ndan al\u0131nd\u0131\u011f\u0131na dair a\u00e7\u0131klama,<br>2- Ba\u015fvuru sonras\u0131nda, imalat\u00e7\u0131 ile ilgili onaylanm\u0131\u015f kurulu\u015f taraf\u0131ndan MDR Ek VII&#8217;nin 4.3 numaral\u0131 maddesinin ikinci alt paragraf\u0131 uyar\u0131nca yaz\u0131l\u0131 bir anla\u015fman\u0131n imzalanm\u0131\u015f oldu\u011funa dair a\u00e7\u0131klama (imalat\u00e7\u0131 bilgileri ve uygulanabilir oldu\u011funda anla\u015fma tarihinin de olmas\u0131 gerekir),<br>3- Anla\u015fma kapsam\u0131nda olan ve s\u00fcre uzat\u0131m\u0131ndan yararlanacak olan cihazlar ile ilgili detayl\u0131 bilgiler ve ilgili cihazlar\u0131n listesi (ilgili belgede anla\u015fma kapsam\u0131 i\u00e7indeki cihazlar\u0131n \u015f\u00fcpheye yer vermeyecek \u015fekilde a\u00e7\u0131k ve tan\u0131mlay\u0131c\u0131 bir \u015fekilde listelenmesi gerekir),<br>4- Bu Duyurunun (B) ve (C)\u2019sinde bahsedilen cihazlar i\u00e7in, anla\u015fma kapsam\u0131ndaki EC Sertifikalar\u0131 ile ilgili bilgiler (sertifikay\u0131 d\u00fczenleyen onaylanm\u0131\u015f kurulu\u015f bilgileri ve EC Sertifika numaras\u0131 dahil),<br>5- Bu teyit mektubunun ge\u00e7erlili\u011finin teyit edilmesi i\u00e7in, belgeyi d\u00fczenleyen onaylanm\u0131\u015f kurulu\u015f yetkilisinin e-posta adresi dahil ileti\u015fim bilgileri (Bu bilginin yer almamas\u0131 halinde teyit maili ilgili Onaylanm\u0131\u015f Kurulu\u015f\u2019un NANDO\u2019da tan\u0131ml\u0131 olan mail adresine at\u0131lacakt\u0131r).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">S\u00fcre uzat\u0131m\u0131n\u0131 ilgilendiren duyuru h\u00fck\u00fcmlerinin tamam\u0131 i\u00e7in: <a href=\"https:\/\/titck.gov.tr\/storage\/Archive\/2023\/announcement\/2023KK5SaylDuyuru_9fdd66d3-afa0-44b2-b45b-6181221d197a.pdf\">2023\/KK-1 Say\u0131l\u0131 (AB) 2023\/607 Say\u0131l\u0131 T\u00fcz\u00fck H\u00fck\u00fcmlerinin Uygulanmas\u0131na Dair Duyuru<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:12px\">Medses, t\u0131bbi cihaz sekt\u00f6r\u00fcnde MDD&#8217;den MDR&#8217;ye ge\u00e7i\u015f s\u00fcrecinde T\u0130TCK taraf\u0131ndan ba\u015fvuru i\u00e7in istenen belgeler hakk\u0131nda bilgilendirme hizmeti veren bir dan\u0131\u015fma hatt\u0131 hizmetidir. Bu platform \u00fczerindeki her t\u00fcrl\u00fc yaz\u0131l\u0131, sesli ve g\u00f6rsel materyalde bulunan i\u00e7erik ve bilgilerinin do\u011fru olmas\u0131n\u0131 sa\u011flamak i\u00e7in m\u00fcmk\u00fcn olan her \u00e7aba g\u00f6sterilmi\u015ftir. Medses arac\u0131l\u0131\u011f\u0131 ile sunulan bilgiler tavsiye niteli\u011finde olup bu bilgiler, y\u00f6nlendirmeler bir nihai h\u00fck\u00fcm de\u011feri ta\u015f\u0131mamaktad\u0131r ve s\u00fcre uzat\u0131m\u0131na dair nihai karar ve d\u00fczenleme yetkisi T\u0130TCK \u2018dad\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:12px\">Medses, hizmete ba\u015fvuran ki\u015filerin, Medses taraf\u0131ndan verilen bilgilerin do\u011frulu\u011fu veya eksiksizli\u011fi konusunda veya Medses taraf\u0131ndan verilen bilgileri kullanmas\u0131 nedeniyle ya da kullan\u0131m\u0131ndan do\u011fan sonu\u00e7lara bak\u0131lmaks\u0131z\u0131n olu\u015fabilecek herhangi bir hata veya eksiklikten, do\u011frudan, dolayl\u0131, \u00f6zel veya ar\u0131zi zararlardan, maliyetlerden, harcamalardan, yasal \u00fccretlerden veya kay\u0131plardan (gelir kay\u0131plar\u0131, k\u00e2r kayb\u0131 ve f\u0131rsat kay\u0131plar\u0131 da dahil olmak \u00fczere) hi\u00e7bir \u015fekilde sorumlu tutulamaz. Medses, T\u0130TCK taraf\u0131ndan istenen belgelerin haz\u0131rlanmas\u0131 veya bu belgelerin T\u0130TCK taraf\u0131ndan onaylanmas\u0131 konusunda herhangi bir garanti veya taahh\u00fct vermemektedir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Onaylanm\u0131\u015f Kurulu\u015f Beyan\u0131; s\u00fcre uzat\u0131m\u0131 s\u00fcrecinde \u00fcreticinin onaylanm\u0131\u015f kurulu\u015ftan, ba\u015fvuru yap\u0131lan cihaz veya cihazlar\u0131n s\u00fcre uzat\u0131m\u0131 i\u00e7in gerekli ko\u015fullar\u0131 ta\u015f\u0131d\u0131\u011f\u0131na dair ald\u0131\u011f\u0131 bir beyand\u0131r. Bu belgede bulunmas\u0131 gereken asgari ko\u015fullar ise T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu &#8216;nun 2023\/KK-1 duyurusu adl\u0131 duyurusunun Ek-2 sinde belirtilmi\u015ftir. Bu ko\u015fullar\u0131n ne oldu\u011fu a\u015fa\u011f\u0131da verilmi\u015ftir ayr\u0131ca s\u00f6z konusu belgeye [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":58,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-57","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-msmedses"],"_links":{"self":[{"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/posts\/57","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medses.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=57"}],"version-history":[{"count":5,"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/posts\/57\/revisions"}],"predecessor-version":[{"id":174,"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/posts\/57\/revisions\/174"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/media\/58"}],"wp:attachment":[{"href":"https:\/\/medses.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=57"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medses.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=57"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medses.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=57"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}