{"id":5346,"date":"2023-07-27T10:43:30","date_gmt":"2023-07-27T07:43:30","guid":{"rendered":"http:\/\/elazigtso.com\/tr\/index.php\/2023\/07\/27\/ukca-isareti\/"},"modified":"2023-07-27T10:43:30","modified_gmt":"2023-07-27T07:43:30","slug":"ukca-isareti","status":"publish","type":"post","link":"https:\/\/elazigtso.org.tr\/tr\/index.php\/2023\/07\/27\/ukca-isareti\/","title":{"rendered":"UKCA \u0130\u015fareti"},"content":{"rendered":"<\/p>\n<div class=\"content-detail\">\n<p>Say\u0131n \u00dcyemiz,<\/p>\n<p>TOBB taraf\u0131ndan Odam\u0131za g\u00f6nderilen yaz\u0131da,\u00a0T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu&#8217;ndan al\u0131nan 07.09.2022 tarihli ve 858637 say\u0131l\u0131 yaz\u0131s\u0131na atfen.\u00a0A\u015fa\u011f\u0131da sunulan ilgi yaz\u0131da, Birle\u015fik Krall\u0131k&#8217;a t\u0131bbi cihaz ihracat\u0131na y\u00f6nelik dikkat edilmesi gereken hususlar ve gereklilikler hakk\u0131nda bilgi verilmi\u015ftir.<\/p>\n<p>&#8220;Bilindi\u011fi \u00fczere Birle\u015fik Krall\u0131k (BK) 31 Ocak 2020 tarihi itibar\u0131yla Avrupa Birli\u011fi (AB)\u2019den<br \/>\nayr\u0131lm\u0131\u015ft\u0131r. Ayr\u0131l\u0131\u015f\u0131n akabinde ba\u015flayan ge\u00e7i\u015f s\u00fcreci de 1 Ocak 2021 tarihinde sona ermi\u015ftir. 1 Ocak 2021<br \/>\ntarihinden itibaren BK pazar\u0131na \u00fcr\u00fcn arz edilirken yap\u0131lmas\u0131 gerekenler ve tabi olunacak kurallar \u00fcr\u00fcn<br \/>\ngruplar\u0131 i\u00e7in birtak\u0131m farkl\u0131l\u0131klar g\u00f6stermektedir. BK\u2019da 1 Ocak 2023 tarihinden itibaren CE i\u015faretinin<br \/>\nyerini alacak olan UKCA (UK Conformity Assessed) i\u015faretinin uygulamas\u0131na ge\u00e7ilecektir. BK taraf\u0131ndan<br \/>\n20 Haziran 2022 tarihinde yap\u0131lan bir duyuru ile t\u0131bbi cihazlar hari\u00e7 olmak \u00fczere baz\u0131 \u00fcr\u00fcn gruplar\u0131na<br \/>\ny\u00f6nelik olarak UKCA i\u015faretinin uygulamas\u0131na dair i\u015f d\u00fcnyas\u0131na y\u00f6nelik kolayla\u015ft\u0131r\u0131c\u0131 uygulamalar<br \/>\na\u00e7\u0131klanm\u0131\u015ft\u0131r. Konuya ili\u015fkin duyuru metni ile rehber dok\u00fcmana a\u015fa\u011f\u0131daki adreslerden eri\u015filebilmektedir.<\/p>\n<p>-https:\/\/www.gov.uk\/government\/news\/government-to-make-it-simpler-for-businesses-to-applynew-product-safety-markings\n<\/p>\n<p>-https:\/\/www.gov.uk\/guidance\/placing-manufactured-goods-on-the-market-in-great-britain<\/p>\n<p>Bahse konu esnekliklerin uygulanaca\u011f\u0131 \u00fcr\u00fcn gruplar\u0131 ile esnekliklerin uygulanmayaca\u011f\u0131 ve \u00f6zel<br \/>\nd\u00fczenlemelere tabi olacak di\u011fer \u00fcr\u00fcn gruplar\u0131n\u0131n listesi yukar\u0131da ba\u011flant\u0131s\u0131 verilen a\u00e7\u0131klama metinlerinde<br \/>\nyer almaktad\u0131r. T\u0131bbi cihazlar, s\u00f6z konusu \u00f6zel d\u00fczenlemelere tabi olacak \u00fcr\u00fcn gruplar\u0131 i\u00e7inde yer<br \/>\nalmaktad\u0131r.<\/p>\n<p>Bununla birlikte, CE i\u015fareti B\u00fcy\u00fck Britanya&#8217;da 30 Haziran 2023&#8217;e kadar tan\u0131nmaya devam<br \/>\nedecektir. AB taraf\u0131ndan tan\u0131nan Onaylanm\u0131\u015f Kurulu\u015flar taraf\u0131ndan verilen sertifikalar, 30 Haziran 2023&#8217;e<br \/>\nkadar B\u00fcy\u00fck Britanya pazar\u0131 i\u00e7in ge\u00e7erli olmaya devam edecektir. Ancak, 1 Temmuz 2023 tarihinden<br \/>\nitibaren BK\u2019da t\u0131bbi cihazlar\u0131n piyasaya arz edilebilmesi i\u00e7in UK MDR 2002\u2019e uygun olarak ili\u015ftirilen<br \/>\nUKCA i\u015fareti ta\u015f\u0131malar\u0131 gerekli olacakt\u0131r.<\/p>\n<p>\u0130lave olarak, \u00fclkemizdeki t\u0131bbi cihaz imalat\u00e7\u0131lar\u0131n\u0131n BK\u2019ya t\u0131bbi cihaz ihracat\u0131 yapabilmeleri<br \/>\ni\u00e7in;\n<\/p>\n<ul>\n<li> BK\u2019da yerle\u015fik bir yetkili temsilci atamalar\u0131 (UK Responsible Person),<\/li>\n<li>\n \u0130n vitro tan\u0131 t\u0131bbi cihazlar\u0131, sistem i\u015flem paketleri, \u0131smarlama imal edilen cihazlar d\u00e2hil olmak<br \/>\n\u00fczere BK\u2019da piyasaya arz edecekleri t\u00fcm t\u0131bbi cihazlar i\u00e7in atad\u0131klar\u0131 yetkili temsilci vas\u0131tas\u0131yla bu<br \/>\nalanda yetkili otorite olan MHRA\u2019ya kay\u0131t yapt\u0131rmalar\u0131 gerekmektedir.<\/li>\n<\/ul>\n<p>Ayr\u0131ca, BK\u2019n\u0131n T\u0131bbi Cihaz Mevzuat\u0131 ve UKCA i\u015fareti ilgili detayl\u0131 bilgilere;<br \/>\nhttps:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk ba\u011flant\u0131s\u0131 \u00fczerinden eri\u015filebileceksiniz&#8221;<\/p>\n<p>Sayg\u0131lar\u0131m\u0131zla,<\/p>\n<p>Elaz\u0131\u011f Ticaret ve Sanayi Odas\u0131<\/p>\n<\/p>\n<p>\u00a0<\/p>\n<p>Bu duyuru 502 defa okundu. <\/p>\n<p>Ekleme Tarihi :2022-09-15 02:58:00 <\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Say\u0131n \u00dcyemiz, TOBB taraf\u0131ndan Odam\u0131za g\u00f6nderilen yaz\u0131da,\u00a0T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu&#8217;ndan al\u0131nan 07.09.2022 tarihli ve 858637 say\u0131l\u0131 yaz\u0131s\u0131na atfen.\u00a0A\u015fa\u011f\u0131da sunulan ilgi yaz\u0131da, Birle\u015fik Krall\u0131k&#8217;a t\u0131bbi cihaz ihracat\u0131na y\u00f6nelik dikkat edilmesi gereken hususlar ve gereklilikler hakk\u0131nda bilgi verilmi\u015ftir. &#8220;Bilindi\u011fi \u00fczere Birle\u015fik Krall\u0131k (BK) 31 Ocak 2020 tarihi itibar\u0131yla Avrupa Birli\u011fi (AB)\u2019den ayr\u0131lm\u0131\u015ft\u0131r. Ayr\u0131l\u0131\u015f\u0131n akabinde ba\u015flayan [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5650,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-5346","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-duyuru"],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/elazigtso.org.tr\/tr\/wp-content\/uploads\/2023\/07\/logo_news-80.jpg","_links":{"self":[{"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/posts\/5346","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/comments?post=5346"}],"version-history":[{"count":0,"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/posts\/5346\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/media\/5650"}],"wp:attachment":[{"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/media?parent=5346"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/categories?post=5346"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/elazigtso.org.tr\/tr\/index.php\/wp-json\/wp\/v2\/tags?post=5346"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}