{"id":47,"date":"2024-02-20T15:44:51","date_gmt":"2024-02-20T12:44:51","guid":{"rendered":"https:\/\/medses.org\/?p=47"},"modified":"2024-02-23T17:51:38","modified_gmt":"2024-02-23T14:51:38","slug":"uretici-beyani-nedir","status":"publish","type":"post","link":"https:\/\/medses.org\/?p=47","title":{"rendered":"\u00dcretici Beyan\u0131 Nedir?"},"content":{"rendered":"\n

\u00dcretici Beyan\u0131; s\u00fcre uzat\u0131m\u0131 s\u00fcrecinde \u00fcreticinin ilgili cihaz veya cihazlar\u0131n s\u00fcre uzat\u0131m\u0131 i\u00e7in gerekli ko\u015fullar\u0131 ta\u015f\u0131d\u0131\u011f\u0131na, tasar\u0131m\u0131nda \u00f6nemli bir de\u011fi\u015fiklik yap\u0131lmad\u0131\u011f\u0131na, s\u00fcre uzat\u0131m\u0131 i\u00e7in uygun oldu\u011funa dair gerekli ko\u015fullar\u0131 ta\u015f\u0131d\u0131\u011f\u0131na dair bir beyand\u0131r. Bu belgede bulunmas\u0131 gereken asgari ko\u015fullar ise T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu \u2018nun 2023\/KK-1 duyurusu adl\u0131 duyurusunun Ek-1 \u2018inde belirtilmi\u015ftir. Bu ko\u015fullar\u0131n ne oldu\u011fu a\u015fa\u011f\u0131da verilmi\u015ftir ayr\u0131ca s\u00f6z konusu belgeye ait taslak dok\u00fcmana eri\u015fmek i\u00e7in buraya<\/a> t\u0131klayabilirsiniz.<\/p>\n\n\n\n

\u00dcretici Beyan\u0131nda asgari bulunmas\u0131 gerekenler<\/strong><\/p>\n\n\n\n

1- \u0130lgili cihaz\u0131n ya da cihazlar\u0131n 90\/385\/EEC say\u0131l\u0131 Direktife veya 93\/42\/EEC say\u0131l\u0131 Direktife (hangi Direktif kapsam\u0131ndaysa) uygun olmaya devam etti\u011fine dair a\u00e7\u0131klama,
2- \u0130lgili cihaz\u0131n ya da cihazlar\u0131n tasar\u0131m\u0131nda ve kullan\u0131m amac\u0131nda \u00f6nemli bir de\u011fi\u015fiklik olmad\u0131\u011f\u0131na dair a\u00e7\u0131klama,
3- \u0130lgili cihaz\u0131n ya da cihazlar\u0131n; hastalar\u0131n, kullan\u0131c\u0131lar\u0131n veya di\u011fer ki\u015filerin sa\u011fl\u0131\u011f\u0131 veya g\u00fcvenli\u011fine ya da kamu sa\u011fl\u0131\u011f\u0131n\u0131n korunmas\u0131na ili\u015fkin di\u011fer hususlara y\u00f6nelik kabul edilemez bir risk te\u015fkil etmedi\u011fine dair a\u00e7\u0131klama,
4- 26 May\u0131s 2024 tarihinden ge\u00e7 olmamak \u00fczere, MDR Madde 10(9) uyar\u0131nca bir kalite y\u00f6netim sistemini (KYS) uygulamaya koyaca\u011f\u0131na\/koydu\u011funa dair a\u00e7\u0131klama,
5- 26 May\u0131s 2024 tarihinden ge\u00e7 olmamak \u00fczere, s\u00f6z konusu cihazla\/cihazlarla ilgili ya da s\u00f6z konusu cihaz\u0131n\/cihazlar\u0131n yerini almas\u0131 ama\u00e7lanan cihazla\/cihazlarla ilgili uygunluk de\u011ferlendirmesine y\u00f6nelik MDR Ek VII’nin 4.3 numaral\u0131 maddesinin birinci alt paragraf\u0131 uyar\u0131nca, imalat\u00e7\u0131n\u0131n ya da yetkili temsilcisinin bir onaylanm\u0131\u015f kurulu\u015fa resmi bir ba\u015fvuruda bulunmu\u015f oldu\u011funa ya da bulunaca\u011f\u0131na dair a\u00e7\u0131klama (OK\u2019n\u0131n d\u00f6rt haneli tan\u0131mlay\u0131c\u0131 numaras\u0131 dahil bilgileri, ba\u015fvuru kapsam\u0131ndaki EC sertifikas\u0131 numaras\u0131, ba\u015fvuru kapsam\u0131ndaki cihazlar gibi ba\u015fvuru detaylar\u0131n\u0131n da beyanda yer almas\u0131 gerekmektedir),
6- 26 Eyl\u00fcl 2024 tarihinden ge\u00e7 olmamak \u00fczere, ilgili onaylanm\u0131\u015f kurulu\u015f ve imalat\u00e7\u0131 aras\u0131nda MDR Ek VII’nin 4.3 numaral\u0131 maddesinin ikinci alt paragraf\u0131 uyar\u0131nca yaz\u0131l\u0131 bir anla\u015fman\u0131n imzalanm\u0131\u015f oldu\u011funa ya da imzalanaca\u011f\u0131na dair a\u00e7\u0131klama (anla\u015fma kapsam\u0131ndaki EC sertifikas\u0131 numaras\u0131, anla\u015fma kapsam\u0131ndaki cihazlar, MDD EC sertifikas\u0131 ge\u00e7erlilik s\u00fcresi 20.03.2023 tarihinden \u00f6nce ise anla\u015fma tarihi gibi anla\u015fma detaylar\u0131n\u0131n da beyanda yer almas\u0131 gerekmektedir),
7- Bu beyan\u0131n ge\u00e7erlili\u011finin teyit edilmesi i\u00e7in, beyan\u0131 d\u00fczenleyen imalat\u00e7\u0131 firma yetkilisinin e-posta adresi dahil ileti\u015fim bilgileri.<\/p>\n\n\n\n

S\u00fcre uzat\u0131m\u0131n\u0131 ilgilendiren duyuru h\u00fck\u00fcmlerinin tamam\u0131 i\u00e7in: 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>\n\n\n\n

Medses, t\u0131bbi cihaz sekt\u00f6r\u00fcnde MDD’den MDR’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

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\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

\u00dcretici Beyan\u0131; s\u00fcre uzat\u0131m\u0131 s\u00fcrecinde \u00fcreticinin ilgili cihaz veya cihazlar\u0131n s\u00fcre uzat\u0131m\u0131 i\u00e7in gerekli ko\u015fullar\u0131 ta\u015f\u0131d\u0131\u011f\u0131na, tasar\u0131m\u0131nda \u00f6nemli bir de\u011fi\u015fiklik yap\u0131lmad\u0131\u011f\u0131na, s\u00fcre uzat\u0131m\u0131 i\u00e7in uygun oldu\u011funa dair gerekli ko\u015fullar\u0131 ta\u015f\u0131d\u0131\u011f\u0131na dair bir beyand\u0131r. Bu belgede bulunmas\u0131 gereken asgari ko\u015fullar ise T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu \u2018nun 2023\/KK-1 duyurusu adl\u0131 duyurusunun Ek-1 \u2018inde belirtilmi\u015ftir. Bu […]<\/p>\n","protected":false},"author":1,"featured_media":51,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[5,7,8],"class_list":["post-47","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-msmedses","tag-medses","tag-sure-uzatimi","tag-titck"],"_links":{"self":[{"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/posts\/47","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=47"}],"version-history":[{"count":11,"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/posts\/47\/revisions"}],"predecessor-version":[{"id":178,"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/posts\/47\/revisions\/178"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medses.org\/index.php?rest_route=\/wp\/v2\/media\/51"}],"wp:attachment":[{"href":"https:\/\/medses.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=47"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medses.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=47"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medses.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=47"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}