{"id":4413,"date":"2026-11-04T15:12:26","date_gmt":"2026-11-04T12:12:26","guid":{"rendered":"https:\/\/www.karengm.com\/?p=4413"},"modified":"2026-11-04T15:17:03","modified_gmt":"2026-11-04T12:17:03","slug":"set-veya-sistem-islem-paketi-urunlerde-udi-kayit-numarasi","status":"publish","type":"post","link":"https:\/\/www.karengm.com\/?p=4413","title":{"rendered":"Set veya Sistem\/\u0130\u015flem Paketi  \u00dcr\u00fcnlerde UD\u0130 Kay\u0131t Numaras\u0131"},"content":{"rendered":"\n<p class=\"has-medium-font-size\" style=\"font-style:normal;font-weight:700\">Set veya Sistem \u015eeklindeki T\u0131bbi Cihaz Y\u00f6netmeli\u011fi Kapsam\u0131 \u00dcr\u00fcnler UD\u0130 Kay\u0131t Numaras\u0131 Kontrol\u00fc<\/p>\n\n\n\n<p>\u0130thalat i\u015flemleri s\u0131ras\u0131nda TAREKS denetimleri kapsam\u0131nda Set veya Sistem\/\u0130\u015flem paketi t\u0131bbi cihaz \u00fcr\u00fcnlerinde,  Avrupa Birli\u011fi T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR 2017\/745) Ek VI K\u0131s\u0131m C (Madde 6.3) ve Madde 22 kapsam\u0131nda, <strong>bir set veya sistem\/i\u015flem paketini olu\u015fturan t\u0131bbi cihazlar\u0131n her birinde ayr\u0131 ayr\u0131 UDI numaras\u0131 aranmas\u0131 kural olarak zorunludur ancak bunun \u00e7ok kritik istisnalar\u0131 mevcuttur<\/strong>.<\/p>\n\n\n\n<p>MDR&#8217;\u0131n setler (sistem ve i\u015flem paketleri) i\u00e7in getirdi\u011fi iki katmanl\u0131 UDI mant\u0131\u011f\u0131 ve kurallar\u0131 \u015fu \u015fekildedir:<\/p>\n\n\n\n<p><strong>1. Setin Kendisi \u0130\u00e7in UDI Zorunlulu\u011fu<\/strong><\/p>\n\n\n\n<p>MDR Madde 22 uyar\u0131nca bir araya getirilerek olu\u015fturulan sistem veya i\u015flem paketinin (setin) <strong>kendisine ait ba\u011f\u0131ms\u0131z bir UDI (UDI-DI + UDI-PI) ve Basic UDI-DI numaras\u0131 olmak zorundad\u0131r<\/strong>. Bu numara seti olu\u015fturan (birle\u015ftiren) firman\u0131n sorumlulu\u011fundad\u0131r ve setin en d\u0131\u015f ambalaj\u0131na yerle\u015ftirilir.<\/p>\n\n\n\n<p><strong>2. Seti Olu\u015fturan \u0130\u00e7erikteki \u00dcr\u00fcnler \u0130\u00e7in UDI Zorunlulu\u011fu (Genel Kural ve \u0130stisnalar)<\/strong><\/p>\n\n\n\n<p>Kural olarak, setin i\u00e7indeki her bir t\u0131bbi cihaz\u0131n kendi ambalaj\u0131nda veya do\u011frudan \u00fczerinde kendisine ait bir UDI ta\u015f\u0131y\u0131c\u0131s\u0131 bulunmal\u0131d\u0131r. Ancak MDR <strong>a\u015fa\u011f\u0131daki durumlarda set i\u00e7indeki m\u00fcnferit \u00fcr\u00fcnlerde ba\u011f\u0131ms\u0131z UDI aranmas\u0131 zorunlulu\u011funu kald\u0131r\u0131r:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Tek Kullan\u0131ml\u0131k \u00dcr\u00fcn \u0130stisnas\u0131:<\/strong> Set i\u00e7erisinde yer alan, kullan\u0131m amac\u0131 kullan\u0131c\u0131 taraf\u0131ndan genel olarak bilinen, <strong>tek kullan\u0131ml\u0131k (disposable) cihazlar<\/strong> e\u011fer o setin d\u0131\u015far\u0131s\u0131nda tek ba\u015f\u0131na (m\u00fcnferit olarak) kullan\u0131lmayacaksa, kendi \u00fczerlerinde ayr\u0131 bir UDI barkodu ta\u015f\u0131mak zorunda de\u011fildir. Bu \u00fcr\u00fcnlerin izlenebilirli\u011fi d\u0131\u015f ambalajdaki set UDI&#8217;si \u00fczerinden y\u00fcr\u00fct\u00fcl\u00fcr.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Yeniden Kullan\u0131labilir Cihazlar:<\/strong> Set i\u00e7inde yer alan ve cerrahi el aletleri gibi <strong>yeniden kullan\u0131labilen (reusable)<\/strong> cihazlar setten ba\u011f\u0131ms\u0131z olarak steril edilip tekrar tekrar kullan\u0131laca\u011f\u0131 i\u00e7in, bunlar\u0131n kendi \u00fczerlerinde (tercihen do\u011frudan markalama\/lazer ile) kendilerine ait UDI ta\u015f\u0131malar\u0131 \u015fartt\u0131r.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00a0<strong>Ayr\u0131 Sat\u0131\u015f Potansiyeli:<\/strong> Set i\u00e7indeki bir \u00fcr\u00fcn, gerekti\u011finde setten \u00e7\u0131kar\u0131l\u0131p piyasada tek ba\u015f\u0131na da sat\u0131labilecek bir t\u0131bbi cihaz ise kesinlikle kendi UDI numaras\u0131na sahip olmak zorundad\u0131r.<\/li>\n<\/ul>\n\n\n\n<p><strong>\u00d6zet Tablo<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u00dcr\u00fcn T\u00fcr\u00fc (Set \u0130\u00e7indeki)<\/strong><\/td><td><strong>Kendi UDI Ta\u015f\u0131y\u0131c\u0131s\u0131 Zorunlu mu?<\/strong><\/td><td><strong>Nedeni \/ \u015eart\u0131<\/strong><\/td><\/tr><tr><td><strong>Setin D\u0131\u015f Ambalaj\u0131<\/strong><\/td><td><strong>Evet (Zorunlu)<\/strong><\/td><td>Set\/Sistem paketi \u00fcreticisinin atad\u0131\u011f\u0131 yeni UDI.<\/td><\/tr><tr><td><strong>Tek Kullan\u0131ml\u0131k Cihazlar<\/strong><\/td><td><strong>Hay\u0131r (Muaf tutulabilir)<\/strong><\/td><td>Sadece set i\u00e7inde kullan\u0131lacak ve d\u0131\u015far\u0131da tekil sat\u0131lmayacaksa.<\/td><\/tr><tr><td><strong>Yeniden Kullan\u0131labilir Cihazlar<\/strong><\/td><td><strong>Evet (Zorunlu)<\/strong><\/td><td>Set d\u0131\u015f\u0131na \u00e7\u0131k\u0131p tekrar sterilizasyon ve kullan\u0131m g\u00f6rece\u011fi i\u00e7in.<\/td><\/tr><tr><td><strong>Tek Ba\u015f\u0131na Da Sat\u0131lan Cihazlar<\/strong><\/td><td><strong>Evet (Zorunlu)<\/strong><\/td><td>Piyasaya m\u00fcnferit olarak arz edilebilme \u00f6zelli\u011fi ta\u015f\u0131d\u0131\u011f\u0131 i\u00e7in.<\/td><\/tr><\/tbody><\/table><figcaption class=\"wp-element-caption\">E\u011fer set i\u00e7erisine koyulan \u015f\u0131r\u0131ngalar, \u00fcreticinin normalde piyasada tekli olarak da satt\u0131\u011f\u0131, kendi \u00f6zel ambalaj\u0131na (blister) sahip standart t\u0131bbi cihazlar ise:<br>Her bir \u015f\u0131r\u0131ngan\u0131n kendi ambalaj\u0131 \u00fczerinde, o \u015f\u0131r\u0131nga modeline ait orijinal <strong>UDI-DI ve \u00fcretim bilgilerini i\u00e7eren UDI-PI (Lot, SKT vb.)<\/strong> karekodunun bulunmas\u0131 gerekir.<br>Set \u00fcreticisi, d\u0131\u015f ambalajda t\u00fcm seti kapsayan yeni bir Set UDI&#8217;si kullan\u0131rken, i\u00e7erideki cihazlar\u0131n kendi kimliklerini (orijinal barkodlar\u0131n\u0131) \u00dcTS sisteminde set bile\u015feni olarak beyan eder.<\/figcaption><\/figure>\n\n\n\n<p>Avrupa Birli\u011fi T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR 2017\/745)<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Set veya Sistem \u015eeklindeki T\u0131bbi Cihaz Y\u00f6netmeli\u011fi Kapsam\u0131 \u00dcr\u00fcnler UD\u0130 Kay\u0131t Numaras\u0131 Kontrol\u00fc \u0130thalat i\u015flemleri s\u0131ras\u0131nda TAREKS denetimleri kapsam\u0131nda Set veya Sistem\/\u0130\u015flem paketi t\u0131bbi cihaz \u00fcr\u00fcnlerinde, Avrupa Birli\u011fi T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR 2017\/745) Ek VI K\u0131s\u0131m C (Madde 6.3) ve Madde 22 kapsam\u0131nda, bir set veya sistem\/i\u015flem paketini olu\u015fturan t\u0131bbi cihazlar\u0131n her birinde ayr\u0131 ayr\u0131 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2335,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4413","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-genel"],"_links":{"self":[{"href":"https:\/\/www.karengm.com\/index.php?rest_route=\/wp\/v2\/posts\/4413"}],"collection":[{"href":"https:\/\/www.karengm.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.karengm.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.karengm.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.karengm.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4413"}],"version-history":[{"count":1,"href":"https:\/\/www.karengm.com\/index.php?rest_route=\/wp\/v2\/posts\/4413\/revisions"}],"predecessor-version":[{"id":4414,"href":"https:\/\/www.karengm.com\/index.php?rest_route=\/wp\/v2\/posts\/4413\/revisions\/4414"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.karengm.com\/index.php?rest_route=\/wp\/v2\/media\/2335"}],"wp:attachment":[{"href":"https:\/\/www.karengm.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4413"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.karengm.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4413"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.karengm.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4413"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}