{"id":18016,"date":"2026-09-14T11:44:56","date_gmt":"2026-09-14T08:44:56","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=18016"},"modified":"2026-09-14T11:45:01","modified_gmt":"2026-09-14T08:45:01","slug":"tibbi-cihaz-ureticisi-olmak-icin-ne-gerekir","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/tibbi-cihaz-ureticisi-olmak-icin-ne-gerekir\/","title":{"rendered":"T\u0131bbi Cihaz \u00dcreticisi Olmak \u0130\u00e7in Ne Gerekir? 2026 Rehberi"},"content":{"rendered":"<style>\n.kk-manufacturer{\nmax-width:960px;margin:0 auto;color:#202124;font-size:17px;line-height:1.78\n}\n.kk-manufacturer h1{font-size:36px;line-height:1.25;color:#111;margin:0 0 22px}\n.kk-manufacturer h2{font-size:27px;line-height:1.35;color:#111;margin:44px 0 17px}\n.kk-manufacturer h3{font-size:21px;line-height:1.4;color:#222;margin:29px 0 12px}\n.kk-manufacturer p{margin:0 0 18px}\n.kk-manufacturer ul,.kk-manufacturer ol{margin:0 0 22px 23px}\n.kk-manufacturer li{margin-bottom:8px}\n.kk-manufacturer a{text-decoration:underline}\n.kk-summary,.kk-info,.kk-warning,.kk-check,.kk-update{\npadding:20px 23px;margin:25px 0;border-radius:6px\n}\n.kk-summary{background:#fafafa;border:1px solid #ddd;border-left:5px solid #111}\n.kk-info{background:#f5f7f9;border-left:4px solid #333}\n.kk-warning{background:#fff7e6;border-left:4px solid #d18b00}\n.kk-check{background:#fafafa;border:1px solid #ddd}\n.kk-update{background:#f8f8f8;border:2px solid #111}\n.kk-summary strong,.kk-update strong{font-size:19px}\n.kk-toc{\nbackground:#f7f7f7;border:1px solid #e1e1e1;padding:23px 26px;\nmargin:30px 0;border-radius:7px\n}\n.kk-toc strong{display:block;font-size:20px;margin-bottom:12px}\n.kk-toc ol{margin-bottom:0}\n.kk-table{overflow-x:auto;margin:25px 0}\n.kk-manufacturer table{width:100%;border-collapse:collapse;min-width:680px}\n.kk-manufacturer th,.kk-manufacturer td{\nborder:1px solid #d7d7d7;padding:12px 14px;text-align:left;vertical-align:top\n}\n.kk-manufacturer th{background:#f3f4f5;font-weight:700}\n.kk-flow{display:flex;flex-wrap:wrap;gap:7px;margin:25px 0}\n.kk-flow span{\nbackground:#f2f2f2;border:1px solid #ddd;padding:9px 12px;\nborder-radius:4px;font-weight:600\n}\n.kk-faq{border-top:1px solid #e4e4e4;padding:20px 0}\n.kk-faq h3{margin-top:0}\n.kk-cta{\nbackground:#111;color:#fff;padding:29px;margin:40px 0;border-radius:7px\n}\n.kk-cta h2{color:#fff;margin-top:0}\n.kk-cta a{\ndisplay:inline-block;background:#fff;color:#111;text-decoration:none;\nfont-weight:700;padding:11px 17px;margin:5px 7px 5px 0;border-radius:4px\n}\n.kk-source{font-size:15px;color:#555}\n@media(max-width:768px){\n.kk-manufacturer{font-size:16px}\n.kk-manufacturer h1{font-size:29px}\n.kk-manufacturer h2{font-size:24px}\n}\n<\/style>\n\n<article class=\"kk-manufacturer\">\n\n\n<p>\n<strong>T\u0131bbi cihaz \u00fcreticisi olmak<\/strong>, yaln\u0131zca bir \u00fcr\u00fcn tasarlay\u0131p \u00fcretime\nba\u015flamak anlam\u0131na gelmez. \u00dcr\u00fcn\u00fcn t\u0131bbi cihaz niteli\u011finin belirlenmesi,\nrisk s\u0131n\u0131f\u0131n\u0131n tespit edilmesi, kalite y\u00f6netim sisteminin kurulmas\u0131,\nteknik dok\u00fcmantasyonun haz\u0131rlanmas\u0131, risk y\u00f6netimi ve klinik de\u011ferlendirmenin\nger\u00e7ekle\u015ftirilmesi, uygunluk de\u011ferlendirmesi, CE i\u015fareti, UDI ve d\u00fczenleyici\nkay\u0131tlar\u0131n birlikte y\u00f6netilmesi gerekir.\n<\/p>\n\n<p>\n\u00dcstelik t\u0131bbi cihaz mevzuat\u0131nda \u201c\u00fcretici\u201d olmak i\u00e7in cihaz\u0131 mutlaka kendi\nfabrikan\u0131zda fiziksel olarak \u00fcretmeniz de gerekmez.\n<\/p>\n\n<div class=\"kk-summary\">\n<strong>K\u0131sa cevap: T\u0131bbi cihaz \u00fcreticisi olmak i\u00e7in ne gerekir?<\/strong>\n\n<p>\n\u00d6ncelikle \u00fcr\u00fcn\u00fcn t\u0131bbi cihaz olup olmad\u0131\u011f\u0131 ve hangi risk s\u0131n\u0131f\u0131na girdi\u011fi belirlenir.\n\u00dcretici, \u00fcr\u00fcne uygun bir kalite y\u00f6netim sistemi kurar; teknik dosya,\nrisk y\u00f6netimi, klinik de\u011ferlendirme, test ve validasyonlar\u0131 tamamlar.\nCihaz s\u0131n\u0131f\u0131na g\u00f6re gerekiyorsa Onaylanm\u0131\u015f Kurulu\u015f s\u00fcrece dahil edilir.\n<\/p>\n\n<p>\nUygunluk de\u011ferlendirmesi tamamland\u0131ktan sonra AB Uygunluk Beyan\u0131 d\u00fczenlenir,\nCE i\u015fareti ili\u015ftirilir, UDI gereklilikleri yerine getirilir ve uygulanabilir\n\u00dcTS\/EUDAMED kay\u0131tlar\u0131 tamamlan\u0131r.\n<\/p>\n\n<p>\nAyr\u0131ca MDR kapsam\u0131nda \u00fcreticinin PRRC, PMS, vigilance, \u015fik\u00e2yet,\nuygunsuzluk ve \u00fcr\u00fcn de\u011fi\u015fikli\u011fi gibi piyasaya arz sonras\u0131 y\u00fck\u00fcml\u00fcl\u00fckleri de vard\u0131r.\n<\/p>\n<\/div>\n\n<nav class=\"kk-toc\" aria-label=\"\u0130\u00e7indekiler\">\n<strong>\u0130\u00e7indekiler<\/strong>\n<ol>\n<li><a href=\"#imalatci-nedir\">T\u0131bbi cihaz imalat\u00e7\u0131s\u0131 kimdir?<\/a><\/li>\n<li><a href=\"#fason\">Fason \u00fcretim yapt\u0131ran firma \u00fcretici say\u0131l\u0131r m\u0131?<\/a><\/li>\n<li><a href=\"#ilk-adim\">\u0130lk ad\u0131m: \u00dcr\u00fcn t\u0131bbi cihaz m\u0131?<\/a><\/li>\n<li><a href=\"#amac\">Ama\u00e7lanan kullan\u0131m neden \u00f6nemli?<\/a><\/li>\n<li><a href=\"#siniflandirma\">Risk s\u0131n\u0131f\u0131 nas\u0131l belirlenir?<\/a><\/li>\n<li><a href=\"#kys\">Kalite y\u00f6netim sistemi zorunlu mu?<\/a><\/li>\n<li><a href=\"#iso13485\">ISO 13485 belgesi zorunlu mu?<\/a><\/li>\n<li><a href=\"#teknik-dosya\">Teknik dosya haz\u0131rlanmas\u0131<\/a><\/li>\n<li><a href=\"#risk\">ISO 14971 risk y\u00f6netimi<\/a><\/li>\n<li><a href=\"#klinik\">Klinik de\u011ferlendirme<\/a><\/li>\n<li><a href=\"#test\">Test ve validasyonlar<\/a><\/li>\n<li><a href=\"#etiket\">Etiket ve kullan\u0131m k\u0131lavuzu<\/a><\/li>\n<li><a href=\"#nb\">Onaylanm\u0131\u015f Kurulu\u015f gerekli mi?<\/a><\/li>\n<li><a href=\"#prrc\">PRRC gerekli mi?<\/a><\/li>\n<li><a href=\"#udi\">UDI ve Basic UDI-DI<\/a><\/li>\n<li><a href=\"#eudamed\">EUDAMED<\/a><\/li>\n<li><a href=\"#uts\">T\u00fcrkiye&#8217;de \u00dcTS<\/a><\/li>\n<li><a href=\"#satis-merkezi\">Sat\u0131\u015f merkezi yetkilendirmesi<\/a><\/li>\n<li><a href=\"#yazilim\">Yaz\u0131l\u0131m firmas\u0131 t\u0131bbi cihaz \u00fcreticisi olabilir mi?<\/a><\/li>\n<li><a href=\"#pms\">CE sonras\u0131nda \u00fcreticinin y\u00fck\u00fcml\u00fcl\u00fckleri<\/a><\/li>\n<li><a href=\"#maliyet\">T\u0131bbi cihaz \u00fcreticisi olman\u0131n maliyeti<\/a><\/li>\n<li><a href=\"#kontrol\">Ba\u015flang\u0131\u00e7 kontrol listesi<\/a><\/li>\n<li><a href=\"#sss\">S\u0131k sorulan sorular<\/a><\/li>\n<\/ol>\n<\/nav>\n\n<h2 id=\"imalatci-nedir\">T\u0131bbi Cihaz \u0130malat\u00e7\u0131s\u0131 Kimdir?<\/h2>\n\n<p>\nT\u0131bbi Cihaz Y\u00f6netmeli\u011finde imalat\u00e7\u0131;\nbir cihaz\u0131 imal eden veya tamamen yenileyen ya da\n<strong>tasarlanm\u0131\u015f veya imal edilmi\u015f bir cihaz\u0131 olan ve bu cihaz\u0131 kendi ad\u0131\nveya ticari markas\u0131 alt\u0131nda pazarlayan ger\u00e7ek veya t\u00fczel ki\u015fi<\/strong>\nolarak tan\u0131mlan\u0131r.\n<\/p>\n\n<p>\nBu tan\u0131m t\u0131bbi cihaz sekt\u00f6r\u00fcne yeni girecek firmalar a\u00e7\u0131s\u0131ndan olduk\u00e7a \u00f6nemlidir.\n<\/p>\n\n<p>\n\u00c7\u00fcnk\u00fc mevzuattaki \u00fcretici kavram\u0131 ile g\u00fcnl\u00fck hayatta kulland\u0131\u011f\u0131m\u0131z\n\u201cfabrikada \u00fcr\u00fcn\u00fc ger\u00e7ekten yapan \u015firket\u201d kavram\u0131 ayn\u0131 de\u011fildir.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>\u00d6nemli:<\/strong>\n<p>\n\u00dcr\u00fcn\u00fcn tasar\u0131m\u0131n\u0131 veya \u00fcretimini ba\u015fka bir firmaya yapt\u0131rman\u0131z,\nsizi otomatik olarak t\u0131bbi cihaz \u00fcreticisi olmaktan \u00e7\u0131karmaz.\nCihaz sizin ad\u0131n\u0131z veya markan\u0131z alt\u0131nda piyasaya arz ediliyorsa\nmevzuattaki \u00fcretici rol\u00fcn\u00fcz ayr\u0131ca de\u011ferlendirilmelidir.\n<\/p>\n<\/div>\n\n<h2 id=\"fason\">Fason T\u0131bbi Cihaz \u00dcretimi Yapt\u0131r\u0131labilir mi?<\/h2>\n\n<p>\nEvet. T\u0131bbi cihaz \u00fcreticisinin b\u00fct\u00fcn \u00fcretim operasyonlar\u0131n\u0131 kendi tesisinde\nger\u00e7ekle\u015ftirmesi zorunlu de\u011fildir.\n<\/p>\n\n<p>\n\u00dcretici;\n<\/p>\n\n<ul>\n<li>\u00fcr\u00fcn\u00fc kendisi tasarlayabilir,<\/li>\n<li>tasar\u0131m\u0131 d\u0131\u015far\u0131dan yapt\u0131rabilir,<\/li>\n<li>\u00fcr\u00fcn\u00fc kendi tesisinde \u00fcretebilir,<\/li>\n<li>\u00fcretimin bir b\u00f6l\u00fcm\u00fcn\u00fc d\u0131\u015far\u0131ya verebilir veya<\/li>\n<li>\u00fcr\u00fcn\u00fcn tamam\u0131n\u0131 s\u00f6zle\u015fmeli \u00fcreticiye \u00fcrettirebilir.<\/li>\n<\/ul>\n\n<p>\nAncak cihaz sizin ad\u0131n\u0131z veya ticari markan\u0131z alt\u0131nda piyasaya sunuluyorsa\n<strong>\u00fcretici sorumlulu\u011funun ta\u015ferona devredildi\u011fi d\u00fc\u015f\u00fcn\u00fclmemelidir.<\/strong>\n<\/p>\n\n<p>\nT\u0131bbi Cihaz Y\u00f6netmeli\u011fi ayr\u0131ca cihaz\u0131n ba\u015fka bir ger\u00e7ek veya t\u00fczel ki\u015fiye\ntasarlat\u0131lmas\u0131 veya imal ettirilmesi halinde bu ki\u015finin kimli\u011fine ili\u015fkin\nbilgilerin d\u00fczenleyici kay\u0131t yap\u0131s\u0131n\u0131n par\u00e7as\u0131 olmas\u0131n\u0131 \u00f6ng\u00f6r\u00fcr.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>\u201cFason \u00fcretici CE&#8217;yi halleder, ben sadece markam\u0131 koyar\u0131m\u201d yakla\u015f\u0131m\u0131 risklidir.<\/strong>\n<p>\nKendi ad\u0131n\u0131z veya markan\u0131z alt\u0131nda cihaz piyasaya arz ediyorsan\u0131z,\nteknik dosya, kalite y\u00f6netim sistemi, risk y\u00f6netimi, klinik de\u011ferlendirme,\nPMS ve di\u011fer \u00fcretici y\u00fck\u00fcml\u00fcl\u00fcklerinin kim taraf\u0131ndan ve nas\u0131l\nkar\u015f\u0131land\u0131\u011f\u0131n\u0131 a\u00e7\u0131k \u015fekilde y\u00f6netmeniz gerekir.\n<\/p>\n<\/div>\n\n<h2 id=\"ilk-adim\">1. \u00d6nce \u00dcr\u00fcn\u00fcn Ger\u00e7ekten T\u0131bbi Cihaz Oldu\u011funu Belirleyin<\/h2>\n\n<p>\nT\u0131bbi cihaz \u00fcretimine ba\u015flamadan \u00f6nce yap\u0131lacak ilk i\u015flem fabrika kurmak\nveya CE belgesi i\u00e7in ba\u015fvurmak de\u011fildir.\n<\/p>\n\n<p>\n\u0130lk soru:\n<\/p>\n\n<p><strong>\u201c\u00dcr\u00fcn\u00fcm\u00fcz ger\u00e7ekten t\u0131bbi cihaz m\u0131?\u201d<\/strong><\/p>\n\n<p>\nBir \u00fcr\u00fcn\u00fcn sa\u011fl\u0131k sekt\u00f6r\u00fcnde kullan\u0131lmas\u0131 veya \u00fczerinde \u201cmedical\u201d yazmas\u0131\nonu otomatik olarak t\u0131bbi cihaz yapmaz.\n<\/p>\n\n<p>De\u011ferlendirmede \u00f6zellikle;<\/p>\n\n<ul>\n<li>ama\u00e7lanan kullan\u0131m,<\/li>\n<li>\u00fcr\u00fcn\u00fcn kullan\u0131c\u0131ya sa\u011flad\u0131\u011f\u0131 temel fonksiyon,<\/li>\n<li>etki mekanizmas\u0131,<\/li>\n<li>hedef hasta\/kullan\u0131c\u0131,<\/li>\n<li>\u00fcreticinin \u00fcr\u00fcn i\u00e7in ileri s\u00fcrd\u00fc\u011f\u00fc iddialar<\/li>\n<\/ul>\n\n<p>\nbirlikte de\u011ferlendirilmelidir.\n<\/p>\n\n<p>\nBu a\u015famada yap\u0131lan yanl\u0131\u015f bir \u00fcr\u00fcn nitelendirmesi sonraki b\u00fct\u00fcn\nCE ve teknik dosya s\u00fcrecini yanl\u0131\u015f temele oturtabilir.\n<\/p>\n\n<h2 id=\"amac\">2. Ama\u00e7lanan Kullan\u0131m\u0131 Net Olarak Tan\u0131mlay\u0131n<\/h2>\n\n<p>\nT\u0131bbi cihaz \u00fcretim s\u00fcrecinin en kritik dok\u00fcmanlar\u0131ndan biri\n<strong>ama\u00e7lanan kullan\u0131md\u0131r (intended purpose).<\/strong>\n<\/p>\n\n<p>\nAma\u00e7lanan kullan\u0131m;\n<\/p>\n\n<ul>\n<li>\u00fcr\u00fcn\u00fcn ne yapt\u0131\u011f\u0131n\u0131,<\/li>\n<li>hangi t\u0131bbi ama\u00e7la kullan\u0131ld\u0131\u011f\u0131n\u0131,<\/li>\n<li>kim taraf\u0131ndan kullan\u0131laca\u011f\u0131n\u0131,<\/li>\n<li>hangi hasta grubunu hedefledi\u011fini,<\/li>\n<li>hangi ortamda kullan\u0131laca\u011f\u0131n\u0131<\/li>\n<\/ul>\n\n<p>\ntan\u0131mlamal\u0131d\u0131r.\n<\/p>\n\n<p>\nBu bilgi yaln\u0131zca teknik dosyan\u0131n giri\u015f b\u00f6l\u00fcm\u00fcne yaz\u0131lmaz.\nAma\u00e7lanan kullan\u0131m;\n<\/p>\n\n<div class=\"kk-flow\">\n<span>S\u0131n\u0131fland\u0131rma<\/span>\n<span>\u2192<\/span>\n<span>Risk Y\u00f6netimi<\/span>\n<span>\u2192<\/span>\n<span>Klinik De\u011ferlendirme<\/span>\n<span>\u2192<\/span>\n<span>Testler<\/span>\n<span>\u2192<\/span>\n<span>Etiket<\/span>\n<span>\u2192<\/span>\n<span>IFU<\/span>\n<span>\u2192<\/span>\n<span>PMS<\/span>\n<\/div>\n\n<p>\nzincirinin temel girdilerinden biridir.\n<\/p>\n\n<h2 id=\"siniflandirma\">3. T\u0131bbi Cihaz\u0131n Risk S\u0131n\u0131f\u0131n\u0131 Belirleyin<\/h2>\n\n<p>\nMDR kapsam\u0131nda cihazlar temel olarak;\n<strong>Class I, Class IIa, Class IIb ve Class III<\/strong>\nrisk s\u0131n\u0131flar\u0131na ayr\u0131l\u0131r.\n<\/p>\n\n<p>\nClass I cihazlarda ayr\u0131ca steril cihazlar (Is), \u00f6l\u00e7\u00fcm fonksiyonlu cihazlar (Im)\nve yeniden kullan\u0131labilir cerrahi aletler (Ir) i\u00e7in \u00f6zel durumlar bulunur.\n<\/p>\n\n<p>\nS\u0131n\u0131fland\u0131rma \u00fcr\u00fcn ad\u0131na bak\u0131larak yap\u0131lmaz.\nMDR Annex VIII s\u0131n\u0131fland\u0131rma kurallar\u0131 cihaz\u0131n;\n<\/p>\n\n<ul>\n<li>kullan\u0131m s\u00fcresi,<\/li>\n<li>invazivli\u011fi,<\/li>\n<li>aktif cihaz niteli\u011fi,<\/li>\n<li>anatomik b\u00f6lgesi,<\/li>\n<li>\u00f6l\u00e7\u00fcm fonksiyonu,<\/li>\n<li>steril sunumu,<\/li>\n<li>yaz\u0131l\u0131m fonksiyonu ve<\/li>\n<li>ama\u00e7lanan kullan\u0131m\u0131<\/li>\n<\/ul>\n\n<p>\n\u00fczerinden de\u011ferlendirilir.\n<\/p>\n\n<p>\n\u00d6n de\u011ferlendirme i\u00e7in\n<a href=\"\/en\/tibbi-cihaz-siniflandirma-araci\/\">\n<strong>KaliteKit T\u0131bbi Cihaz S\u0131n\u0131fland\u0131rma Arac\u0131n\u0131<\/strong>\n<\/a>\nkullanabilirsiniz.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>S\u0131n\u0131fland\u0131rmay\u0131 \u00fcr\u00fcn geli\u015ftirme bittikten sonraya b\u0131rakmay\u0131n.<\/strong>\n<p>\nCihaz s\u0131n\u0131f\u0131 uygunluk de\u011ferlendirme yolunu, klinik kan\u0131t ihtiyac\u0131n\u0131,\nOnaylanm\u0131\u015f Kurulu\u015f gereklili\u011fini ve projenin maliyet\/s\u00fcre plan\u0131n\u0131 do\u011frudan etkileyebilir.\n<\/p>\n<\/div>\n\n<h2 id=\"kys\">4. T\u0131bbi Cihaz \u00dcreticisinin Kalite Y\u00f6netim Sistemi Olmal\u0131 m\u0131?<\/h2>\n\n<p>\n<strong>Evet.<\/strong>\n<\/p>\n\n<p>\nMDR Madde 10(9), \u00fcreticilerin risk s\u0131n\u0131f\u0131 ve cihaz tipiyle orant\u0131l\u0131 \u015fekilde\nbir <strong>kalite y\u00f6netim sistemi (KYS)<\/strong> kurmas\u0131n\u0131,\ndok\u00fcmante etmesini, uygulamas\u0131n\u0131, s\u00fcrd\u00fcrmesini ve g\u00fcncel tutmas\u0131n\u0131 ister.\n<\/p>\n\n<p>\nBu sistem yaln\u0131zca birka\u00e7 prosed\u00fcr haz\u0131rlamaktan ibaret de\u011fildir.\n<\/p>\n\n<p>KYS&#8217;nin kapsam\u0131nda \u00f6rne\u011fin;<\/p>\n\n<ul>\n<li>mevzuata uyum stratejisi,<\/li>\n<li>y\u00f6netim sorumlulu\u011fu,<\/li>\n<li>kaynak y\u00f6netimi,<\/li>\n<li>tedarik\u00e7i ve alt y\u00fcklenici kontrol\u00fc,<\/li>\n<li>risk y\u00f6netimi,<\/li>\n<li>klinik de\u011ferlendirme,<\/li>\n<li>\u00fcr\u00fcn ger\u00e7ekle\u015ftirme,<\/li>\n<li>tasar\u0131m ve geli\u015ftirme,<\/li>\n<li>UDI gereklilikleri,<\/li>\n<li>PMS ve PMCF,<\/li>\n<li>vigilance,<\/li>\n<li>CAPA,<\/li>\n<li>uygunsuz \u00fcr\u00fcn y\u00f6netimi<\/li>\n<\/ul>\n\n<p>\ngibi s\u00fcre\u00e7ler bulunmal\u0131d\u0131r.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>T\u0131bbi cihaz KYS&#8217;sinde temel mant\u0131k:<\/strong>\n<p>\nProsed\u00fcr \u2192 Ger\u00e7ek uygulama \u2192 Kay\u0131t \u2192 Kan\u0131t \u2192 \u0130zleme \u2192 \u0130yile\u015ftirme\n<\/p>\n<\/div>\n\n<h2 id=\"iso13485\">5. T\u0131bbi Cihaz \u00dcretmek \u0130\u00e7in ISO 13485 Belgesi Zorunlu mu?<\/h2>\n\n<p>\nBu soruda <strong>\u201ckalite y\u00f6netim sistemi zorunlulu\u011fu\u201d<\/strong> ile\n<strong>\u201cISO 13485 sertifikas\u0131\u201d<\/strong> birbirinden ayr\u0131lmal\u0131d\u0131r.\n<\/p>\n\n<p>\nMDR Madde 10(9), t\u0131bbi cihaz \u00fcreticisinin kalite y\u00f6netim sistemi\nkurmas\u0131n\u0131 zorunlu tutar.\n<\/p>\n\n<p>\nISO 13485 ise t\u0131bbi cihaz kalite y\u00f6netim sistemi a\u00e7\u0131s\u0131ndan temel ve\nyayg\u0131n kullan\u0131lan standartt\u0131r.\n<\/p>\n\n<p>\nAncak b\u00fct\u00fcn cihazlar ve b\u00fct\u00fcn uygunluk de\u011ferlendirme yollar\u0131 i\u00e7in\n\u201c\u00f6nce mutlaka ba\u011f\u0131ms\u0131z ISO 13485 sertifikas\u0131 almal\u0131s\u0131n\u0131z, aksi halde\nt\u0131bbi cihaz \u00fcreticisi olamazs\u0131n\u0131z\u201d \u015feklinde genel bir MDR kural\u0131 bulunmaz.\n<\/p>\n\n<h3>Class I cihazlarda durum<\/h3>\n\n<p>\nNormal Class I cihazlarda \u00fcretici belirli istisnalar d\u0131\u015f\u0131nda uygunluk\nde\u011ferlendirmesini kendi sorumlulu\u011funda ger\u00e7ekle\u015ftirebilir.\n<\/p>\n\n<p>\nBuna ra\u011fmen MDR Madde 10(9)&#8217;daki kalite y\u00f6netim sistemi y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc\nClass I \u00fcreticisi a\u00e7\u0131s\u0131ndan da ortadan kalkmaz.\n<\/p>\n\n<h3>Class Is, Im, Ir, IIa, IIb ve III cihazlarda<\/h3>\n\n<p>\nUygulanabilir uygunluk de\u011ferlendirme yoluna g\u00f6re Onaylanm\u0131\u015f Kurulu\u015f\nde\u011ferlendirmesi devreye girer ve kalite y\u00f6netim sistemi de ilgili\nuygunluk de\u011ferlendirme s\u00fcrecinin \u00f6nemli bir par\u00e7as\u0131d\u0131r.\n<\/p>\n\n<div class=\"kk-update\">\n<strong>T\u00fcrkiye a\u00e7\u0131s\u0131ndan 1 Ocak 2027 de\u011fi\u015fikli\u011fini unutmay\u0131n<\/strong>\n<p>\n26 May\u0131s 2023 tarihli de\u011fi\u015fiklikle, yurt i\u00e7inde t\u0131bbi cihaz imalat\u0131 yapan\nilgili sat\u0131\u015f merkezi ba\u015fvuru sahipleri i\u00e7in akredite uygunluk de\u011ferlendirme\nkurulu\u015funca d\u00fczenlenmi\u015f EN ISO 13485 kalite y\u00f6netim sistemi belgesinin\nba\u015fvuru belgeleri aras\u0131na eklenmesine ili\u015fkin h\u00fck\u00fcm getirildi.\n<\/p>\n<p>\nBu h\u00fckm\u00fcn y\u00fcr\u00fcrl\u00fck tarihi <strong>1 Ocak 2027<\/strong>&#8216;dir.\nDolay\u0131s\u0131yla bu gereklili\u011fi 2026 y\u0131l\u0131nda y\u00fcr\u00fcrl\u00fckteymi\u015f gibi de\u011ferlendirmek do\u011fru de\u011fildir.\n<\/p>\n<\/div>\n\n<h2 id=\"teknik-dosya\">6. MDR Teknik Dosyas\u0131n\u0131 Haz\u0131rlay\u0131n<\/h2>\n\n<p>\nT\u0131bbi cihaz \u00fcreticisinin en temel y\u00fck\u00fcml\u00fcl\u00fcklerinden biri\n\u00fcr\u00fcn\u00fcn uygunlu\u011funu g\u00f6sterecek <strong>teknik dok\u00fcmantasyonu<\/strong>\nhaz\u0131rlamak ve g\u00fcncel tutmakt\u0131r.\n<\/p>\n\n<p>\nMDR Annex II ve Annex III do\u011frultusunda teknik dosyada genel olarak;\n<\/p>\n\n<ul>\n<li>cihaz tan\u0131m\u0131,<\/li>\n<li>ama\u00e7lanan kullan\u0131m,<\/li>\n<li>\u00fcr\u00fcn varyantlar\u0131,<\/li>\n<li>s\u0131n\u0131fland\u0131rma ve gerek\u00e7esi,<\/li>\n<li>Basic UDI-DI,<\/li>\n<li>tasar\u0131m bilgileri,<\/li>\n<li>\u00fcretim s\u00fcre\u00e7leri,<\/li>\n<li>GSPR kontrol\u00fc,<\/li>\n<li>risk y\u00f6netimi,<\/li>\n<li>do\u011frulama ve validasyon,<\/li>\n<li>klinik de\u011ferlendirme,<\/li>\n<li>etiket ve kullan\u0131m k\u0131lavuzu,<\/li>\n<li>PMS dok\u00fcmantasyonu<\/li>\n<\/ul>\n\n<p>\ngibi b\u00f6l\u00fcmler bulunur.\n<\/p>\n\n<p>\nTeknik dok\u00fcmantasyon yaln\u0131zca \u201cdenet\u00e7iye verilecek klas\u00f6r\u201d de\u011fildir.\n\u00dcr\u00fcn\u00fcn mevzuata uygun oldu\u011funu g\u00f6steren ya\u015fayan kan\u0131t sistemidir.\n<\/p>\n\n<p>\nAyr\u0131nt\u0131l\u0131 yap\u0131 i\u00e7in\n<a href=\"\/en\/mdr-uyumlu-teknik-dosya-technical-documentation-hazirlama-rehberi\/\">\n<strong>MDR Uyumlu Teknik Dosya Haz\u0131rlama Rehberimizi<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"risk\">7. ISO 14971 Risk Y\u00f6netimi<\/h2>\n\n<p>\nT\u0131bbi cihaz \u00fcreticisi \u00fcr\u00fcn\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca risk y\u00f6netimini\ns\u00fcrd\u00fcrmelidir.\n<\/p>\n\n<p>Risk y\u00f6netimi temel olarak;<\/p>\n\n<ul>\n<li>tehlikelerin tan\u0131mlanmas\u0131,<\/li>\n<li>risklerin tahmin edilmesi,<\/li>\n<li>risklerin de\u011ferlendirilmesi,<\/li>\n<li>risk kontrol \u00f6nlemlerinin belirlenmesi,<\/li>\n<li>kontrollerin uygulanmas\u0131 ve do\u011frulanmas\u0131,<\/li>\n<li>art\u0131k risklerin de\u011ferlendirilmesi ve<\/li>\n<li>\u00fcretim\/piyasa sonras\u0131 verilerin geri beslenmesi<\/li>\n<\/ul>\n\n<p>\nad\u0131mlar\u0131ndan olu\u015fur.\n<\/p>\n\n<p>\nRisk \u00e7al\u0131\u015fman\u0131z\u0131 yap\u0131land\u0131rmak i\u00e7in\n<a href=\"\/en\/iso-14971-bazli-risk-analiz-araci\/\">\n<strong>KaliteKit ISO 14971 Bazl\u0131 Risk Analiz Arac\u0131n\u0131<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"klinik\">8. Klinik De\u011ferlendirme Yap\u0131lmal\u0131 m\u0131?<\/h2>\n\n<p>\nEvet. Klinik de\u011ferlendirme yaln\u0131zca Class III \u00fcr\u00fcnler i\u00e7in gerekli bir\n\u00e7al\u0131\u015fma de\u011fildir.\n<\/p>\n\n<p>\n\u00dcretici MDR gereklilikleri do\u011frultusunda cihaz\u0131n g\u00fcvenli\u011fi ve klinik\nperformans\u0131n\u0131 destekleyen klinik verileri de\u011ferlendirmelidir.\n<\/p>\n\n<p>\nGerekli klinik kan\u0131t seviyesi;\n<\/p>\n\n<ul>\n<li>cihaz s\u0131n\u0131f\u0131,<\/li>\n<li>teknoloji,<\/li>\n<li>ama\u00e7lanan kullan\u0131m,<\/li>\n<li>\u00fcr\u00fcn\u00fcn yenilik seviyesi,<\/li>\n<li>riskler ve<\/li>\n<li>\u00fcreticinin klinik iddialar\u0131<\/li>\n<\/ul>\n\n<p>\ndo\u011frultusunda de\u011fi\u015fir.\n<\/p>\n\n<p>\n\u00d6n de\u011ferlendirme i\u00e7in\n<a href=\"\/en\/klinik-degerlendirme-karar-araci\/\">\n<strong>KaliteKit Klinik De\u011ferlendirme Karar Arac\u0131n\u0131<\/strong>\n<\/a>\nkullanabilirsiniz.\n<\/p>\n\n<h2 id=\"test\">9. Hangi Test ve Validasyonlar Gerekiyor?<\/h2>\n\n<p>\nB\u00fct\u00fcn t\u0131bbi cihazlara uygulanabilecek tek bir test listesi yoktur.\n<\/p>\n\n<p>\n\u00dcreticinin test stratejisi \u00fcr\u00fcn\u00fcn tasar\u0131m\u0131, malzemesi, kullan\u0131m amac\u0131,\nriskleri ve uygulanabilir standartlar \u00fczerinden olu\u015fturulmal\u0131d\u0131r.\n<\/p>\n\n<p>\u00dcr\u00fcne g\u00f6re \u00f6rne\u011fin;<\/p>\n\n<ul>\n<li>biyouyumluluk,<\/li>\n<li>elektriksel g\u00fcvenlik,<\/li>\n<li>EMC,<\/li>\n<li>yaz\u0131l\u0131m V&amp;V,<\/li>\n<li>siber g\u00fcvenlik,<\/li>\n<li>kullan\u0131labilirlik,<\/li>\n<li>sterilizasyon validasyonu,<\/li>\n<li>ambalaj validasyonu,<\/li>\n<li>temizlik validasyonu,<\/li>\n<li>raf \u00f6mr\u00fc,<\/li>\n<li>performans testleri,<\/li>\n<li>mekanik testler<\/li>\n<\/ul>\n\n<p>\ng\u00fcndeme gelebilir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>Rakip \u00fcr\u00fcn\u00fcn test listesini kopyalamay\u0131n.<\/strong>\n<p>\nTest ihtiya\u00e7lar\u0131 kendi \u00fcr\u00fcn\u00fcn\u00fcz\u00fcn GSPR, risk y\u00f6netimi,\nama\u00e7lanan kullan\u0131m ve tasar\u0131m \u00f6zelliklerinden t\u00fcretilmelidir.\n<\/p>\n<\/div>\n\n<h2 id=\"etiket\">10. T\u0131bbi Cihaz Etiketi ve Kullan\u0131m K\u0131lavuzunu Haz\u0131rlay\u0131n<\/h2>\n\n<p>\n\u00dcretici, \u00fcr\u00fcn etiketi ve kullan\u0131m bilgilerinin MDR gerekliliklerini\nkar\u015f\u0131lamas\u0131n\u0131 sa\u011flamal\u0131d\u0131r.\n<\/p>\n\n<p>\nEtiket \u00fczerinde \u00fcr\u00fcne g\u00f6re;\n<\/p>\n\n<ul>\n<li>\u00fcretici ad\u0131 ve adresi,<\/li>\n<li>\u00fcr\u00fcn ad\u0131,<\/li>\n<li>model\/katalog bilgisi,<\/li>\n<li>lot veya seri numaras\u0131,<\/li>\n<li>UDI ta\u015f\u0131y\u0131c\u0131s\u0131,<\/li>\n<li>\u00fcretim\/son kullanma bilgileri,<\/li>\n<li>CE i\u015fareti,<\/li>\n<li>uygulan\u0131yorsa Onaylanm\u0131\u015f Kurulu\u015f numaras\u0131,<\/li>\n<li>saklama \u015fartlar\u0131,<\/li>\n<li>uyar\u0131lar ve semboller<\/li>\n<\/ul>\n\n<p>\ngibi bilgiler bulunabilir.\n<\/p>\n\n<p>\nEtiket haz\u0131rl\u0131\u011f\u0131nda\n<a href=\"\/en\/tibbi-cihaz-etiket-olusturma-iso-15223\/\">\n<strong>T\u0131bbi Cihaz Etiket Olu\u015fturma<\/strong>\n<\/a>\nsayfam\u0131z\u0131 inceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"nb\">11. Onaylanm\u0131\u015f Kurulu\u015f Gerekli mi?<\/h2>\n\n<p>\nHer t\u0131bbi cihaz \u00fcreticisinin Onaylanm\u0131\u015f Kurulu\u015f ile \u00e7al\u0131\u015fmas\u0131 gerekmez.\n<\/p>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Cihaz<\/th>\n<th>Onaylanm\u0131\u015f Kurulu\u015f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Normal Class I<\/td>\n<td>Genel olarak gerekli de\u011fildir.<\/td>\n<\/tr>\n<tr>\n<td>Class Is<\/td>\n<td>Steriliteyle ilgili kapsamda gereklidir.<\/td>\n<\/tr>\n<tr>\n<td>Class Im<\/td>\n<td>\u00d6l\u00e7\u00fcm fonksiyonuyla ilgili kapsamda gereklidir.<\/td>\n<\/tr>\n<tr>\n<td>Class Ir<\/td>\n<td>Yeniden kullan\u0131labilirlikle ilgili belirtilen kapsamda gereklidir.<\/td>\n<\/tr>\n<tr>\n<td>Class IIa<\/td>\n<td>Gereklidir.<\/td>\n<\/tr>\n<tr>\n<td>Class IIb<\/td>\n<td>Gereklidir.<\/td>\n<\/tr>\n<tr>\n<td>Class III<\/td>\n<td>Gereklidir.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<p>\nOnaylanm\u0131\u015f Kurulu\u015f se\u00e7imi cihaz\u0131n risk s\u0131n\u0131f\u0131ndan ibaret de\u011fildir.\nKurulu\u015fun MDR kapsam\u0131nda atanm\u0131\u015f olmas\u0131 ve cihaz\u0131n\u0131z\u0131n ilgili\nyetkilendirme kapsam\u0131n\u0131 kar\u015f\u0131lamas\u0131 gerekir.\n<\/p>\n\n<p>\nCE s\u00fcrecinin tamam\u0131n\u0131\n<a href=\"\/en\/tibbi-cihaz-ce-belgesi-nasil-alinir\/\">\n<strong>T\u0131bbi Cihaz CE Belgesi Nas\u0131l Al\u0131n\u0131r? 2026 MDR Rehberimizden<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"prrc\">12. T\u0131bbi Cihaz \u00dcreticisinin PRRC&#8217;si Olmal\u0131 m\u0131?<\/h2>\n\n<p>\nEvet. MDR Madde 15 kapsam\u0131nda \u00fcreticinin gerekli uzmanl\u0131\u011fa sahip\nen az bir <strong>Mevzuata Uyumdan Sorumlu Ki\u015fi (PRRC)<\/strong>\nbulundurmas\u0131 gerekir.\n<\/p>\n\n<p>\nMikro ve k\u00fc\u00e7\u00fck i\u015fletmeler PRRC&#8217;yi organizasyonlar\u0131n\u0131n i\u00e7erisinde\nbulundurmak zorunda de\u011fildir; ancak uygun nitelikteki ki\u015fiyi\n<strong>s\u00fcrekli ve devaml\u0131 \u015fekilde eri\u015filebilir<\/strong> bulundurmal\u0131d\u0131r.\n<\/p>\n\n<p>\nPRRC;\n<\/p>\n\n<ul>\n<li>\u00fcr\u00fcn uygunluk kontrolleri,<\/li>\n<li>teknik dok\u00fcmantasyon,<\/li>\n<li>AB Uygunluk Beyan\u0131,<\/li>\n<li>PMS ve<\/li>\n<li>vigilance<\/li>\n<\/ul>\n\n<p>\ngibi kritik d\u00fczenleyici alanlarla do\u011frudan ba\u011flant\u0131l\u0131d\u0131r.\n<\/p>\n\n<p>\nKimlerin PRRC olabilece\u011fini\n<a href=\"\/en\/prrc-nedir-kimler-prrc-olabilir\/\">\n<strong>PRRC Nedir? Kimler PRRC Olabilir?<\/strong>\n<\/a>\nrehberimizde ayr\u0131nt\u0131l\u0131 anlatt\u0131k.\n<\/p>\n\n<h2 id=\"udi\">13. UDI ve Basic UDI-DI Olu\u015fturun<\/h2>\n\n<p>\nUDI sistemi t\u0131bbi cihazlar\u0131n tan\u0131mlanmas\u0131 ve izlenebilirli\u011finin \u00f6nemli\nbir par\u00e7as\u0131d\u0131r.\n<\/p>\n\n<p>\n\u00dcreticinin cihaz\u0131na uygulanabilir UDI gerekliliklerini belirlemesi ve\ndo\u011fru tan\u0131mlay\u0131c\u0131 yap\u0131s\u0131n\u0131 olu\u015fturmas\u0131 gerekir.\n<\/p>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Tan\u0131mlay\u0131c\u0131<\/th>\n<th>Temel ama\u00e7<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Basic UDI-DI<\/strong><\/td>\n<td>Cihaz ailesi\/model grubu seviyesinde d\u00fczenleyici temel tan\u0131mlay\u0131c\u0131d\u0131r.<\/td>\n<\/tr>\n<tr>\n<td><strong>UDI-DI<\/strong><\/td>\n<td>Belirli cihaz\/model ve ilgili ambalaj seviyesinin tan\u0131mlay\u0131c\u0131 b\u00f6l\u00fcm\u00fcd\u00fcr.<\/td>\n<\/tr>\n<tr>\n<td><strong>UDI-PI<\/strong><\/td>\n<td>Lot, seri, \u00fcretim tarihi ve benzeri \u00fcretim tan\u0131mlay\u0131c\u0131lar\u0131n\u0131 kapsar.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<p>\nUDI konusunda\n<a href=\"\/en\/udi-di-ve-udi-pi-olusturma-rehberi-tum-adimlar-ve-ornekler\/\">\n<strong>UDI-DI ve UDI-PI Olu\u015fturma Rehberimizi<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"eudamed\">14. EUDAMED Kayd\u0131 \u2013 2026&#8217;da Art\u0131k \u00d6zellikle \u00d6nemli<\/h2>\n\n<div class=\"kk-update\">\n<strong>28 May\u0131s 2026 itibar\u0131yla yeni d\u00f6nem ba\u015flad\u0131.<\/strong>\n<p>\nEUDAMED&#8217;in Actor Registration, UDI\/Device Registration,\nNotified Bodies &amp; Certificates ve Market Surveillance mod\u00fcllerinin\nzorunlu kullan\u0131m\u0131 28 May\u0131s 2026 tarihinde ba\u015flad\u0131.\n<\/p>\n<\/div>\n\n<p>\n\u00dcreticiler a\u00e7\u0131s\u0131ndan \u00f6zellikle Actor ve UDI\/Device kay\u0131tlar\u0131 \u00f6nemlidir.\nAvrupa Komisyonu, \u00fcreticilerin AB pazar\u0131na sunduklar\u0131 cihazlara ili\u015fkin\nUDI\/Device bilgilerini EUDAMED&#8217;e sunmas\u0131n\u0131 gerektirmektedir.\n<\/p>\n\n<p>\nBu nedenle EUDAMED&#8217;i \u201cCE bittikten sonra bakar\u0131z\u201d denilecek ayr\u0131 bir\nidari i\u015flem olarak g\u00f6rmek yerine \u00fcr\u00fcn veri y\u00f6netiminin par\u00e7as\u0131 olarak\nplanlamak daha sa\u011fl\u0131kl\u0131d\u0131r.\n<\/p>\n\n<p>\nY\u00fcksek adetli \u00fcr\u00fcn kay\u0131tlar\u0131 i\u00e7in\n<a href=\"\/en\/service\/eudamed-urun-kayit\/\">\n<strong>KaliteKit EUDAMED \u00dcr\u00fcn Kay\u0131t Deste\u011fini<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"uts\">15. T\u00fcrkiye&#8217;de \u00dcretici Olarak \u00dcTS S\u00fcreci<\/h2>\n\n<p>\nT\u00fcrkiye&#8217;de piyasaya arz edilecek t\u0131bbi cihazlar a\u00e7\u0131s\u0131ndan\n\u00dcr\u00fcn Takip Sistemi kay\u0131t y\u00fck\u00fcml\u00fcl\u00fckleri ayr\u0131ca de\u011ferlendirilmelidir.\n<\/p>\n\n<p>\n\u00dcreticinin firma rol\u00fc ve \u00fcr\u00fcn bilgileri \u00fczerinden gerekli kay\u0131tlar\u0131n\nolu\u015fturulmas\u0131 gerekir.\n<\/p>\n\n<p>\n\u00dcTS kayd\u0131 yaln\u0131zca \u00fcr\u00fcn ad\u0131n\u0131 ve barkodunu sisteme girmek de\u011fildir.\n<\/p>\n\n<p>\u00dcr\u00fcn \u00f6zelinde;<\/p>\n\n<ul>\n<li>\u00fcretici,<\/li>\n<li>risk s\u0131n\u0131f\u0131,<\/li>\n<li>barkod \/ UDI,<\/li>\n<li>marka,<\/li>\n<li>model,<\/li>\n<li>\u00fcr\u00fcn ad\u0131,<\/li>\n<li>uygunluk belgeleri ve<\/li>\n<li>di\u011fer d\u00fczenleyici bilgiler<\/li>\n<\/ul>\n\n<p>\nbirbirleriyle tutarl\u0131 y\u00f6netilmelidir.\n<\/p>\n\n<p>\nFirma s\u00fcrecine yeni ba\u015flayanlar\n<a href=\"\/en\/uts-firma-kaydi-nasil-yapilir-sifirdan-tibbi-cihaz-firmasi-rehberi\/\">\n<strong>\u00dcTS Firma Kayd\u0131 Nas\u0131l Yap\u0131l\u0131r?<\/strong>\n<\/a>\nrehberimizi inceleyebilir.\n<\/p>\n\n<h2 id=\"satis-merkezi\">16. T\u0131bbi Cihaz \u00dcreticisinin Sat\u0131\u015f Merkezi Yetki Belgesi Gerekir mi?<\/h2>\n\n<p>\nT\u00fcrkiye&#8217;deki \u00fcretici yaln\u0131zca MDR kapsam\u0131ndaki \u00fcr\u00fcn uygunlu\u011funu de\u011fil,\nt\u0131bbi cihaz sat\u0131\u015f faaliyetleriyle ilgili ulusal d\u00fczenlemeleri de\nde\u011ferlendirmelidir.\n<\/p>\n\n<p>\nT\u0131bbi Cihaz Sat\u0131\u015f, Reklam ve Tan\u0131t\u0131m Y\u00f6netmeli\u011finin kapsam\u0131,\nt\u0131bbi cihazlar\u0131n \u00fcretim yerleri ile piyasaya arz ve sat\u0131\u015f faaliyetlerini\nde i\u00e7ermektedir.\n<\/p>\n\n<p>\n\u00d6zellikle \u00fcr\u00fcn\u00fc T\u00fcrkiye&#8217;de piyasaya sunacak yurt i\u00e7i imalat\u00e7\u0131 a\u00e7\u0131s\u0131ndan\nsat\u0131\u015f merkezi yetkilendirmesi ve firman\u0131n faaliyet modeli ayr\u0131ca kontrol\nedilmelidir.\n<\/p>\n\n<p>\nBu s\u00fcreci ayr\u0131nt\u0131l\u0131 olarak\n<a href=\"\/en\/tibbi-cihaz-satis-merkezi-nasil-acilir\/\">\n<strong>T\u0131bbi Cihaz Sat\u0131\u015f Merkezi Nas\u0131l A\u00e7\u0131l\u0131r? 2026 Rehberimizde<\/strong>\n<\/a>\nele ald\u0131k.\n<\/p>\n\n<div class=\"kk-update\">\n<strong>2027 i\u00e7in haz\u0131rl\u0131kl\u0131 olun<\/strong>\n<p>\nYurt i\u00e7inde t\u0131bbi cihaz imalat\u0131 yapan ilgili sat\u0131\u015f merkezi ba\u015fvuru sahipleri\na\u00e7\u0131s\u0131ndan akredite uygunluk de\u011ferlendirme kurulu\u015funca d\u00fczenlenmi\u015f\nEN ISO 13485 belgesine ili\u015fkin yeni ba\u015fvuru \u015fart\u0131\n<strong>1 Ocak 2027&#8217;de<\/strong> y\u00fcr\u00fcrl\u00fc\u011fe girecektir.\n<\/p>\n<\/div>\n\n<h2 id=\"yazilim\">17. Yaz\u0131l\u0131m Firmas\u0131 T\u0131bbi Cihaz \u00dcreticisi Olabilir mi?<\/h2>\n\n<p>\n<strong>Evet.<\/strong>\n<\/p>\n\n<p>\nT\u0131bbi cihaz \u00fcreticisi olmak i\u00e7in mutlaka fiziksel bir plastik,\nmetal veya elektronik \u00fcr\u00fcn \u00fcretmek gerekmez.\n<\/p>\n\n<p>\nT\u0131bbi ama\u00e7 ta\u015f\u0131yan yaz\u0131l\u0131mlar da \u015fartlar\u0131 kar\u015f\u0131lamalar\u0131 halinde\nMDR kapsam\u0131nda t\u0131bbi cihaz olabilir.\n<\/p>\n\n<p>\n\u00d6rne\u011fin yaz\u0131l\u0131m;\n<\/p>\n\n<ul>\n<li>tan\u0131,<\/li>\n<li>tedavi karar\u0131,<\/li>\n<li>hasta izleme,<\/li>\n<li>klinik karar deste\u011fi veya<\/li>\n<li>ba\u015fka bir t\u0131bbi ama\u00e7<\/li>\n<\/ul>\n\n<p>\ni\u00e7in tasarlanm\u0131\u015fsa \u00fcr\u00fcn\u00fcn medical device software niteli\u011fi\nayr\u0131ca de\u011ferlendirilmelidir.\n<\/p>\n\n<p>\nBu durumda yaz\u0131l\u0131m \u015firketi de mevzuat a\u00e7\u0131s\u0131ndan\n<strong>t\u0131bbi cihaz \u00fcreticisi<\/strong> olabilir.\n<\/p>\n\n<p>\nKonuyla ilgili\n<a href=\"\/en\/yazilim-medikal-cihazmi\/\">\n<strong>Yaz\u0131l\u0131m Medikal Cihaz m\u0131?<\/strong>\n<\/a>\nrehberimizi inceleyebilirsiniz.\n<\/p>\n\n<h2>18. Fiziksel Fabrikan\u0131z Olmadan T\u0131bbi Cihaz \u00dcreticisi Olabilir misiniz?<\/h2>\n\n<p>\nMevzuattaki imalat\u00e7\u0131 tan\u0131m\u0131 a\u00e7\u0131s\u0131ndan m\u00fcmk\u00fcnd\u00fcr.\n<\/p>\n\n<p>\n\u00dcretimin tamam\u0131n\u0131 veya bir b\u00f6l\u00fcm\u00fcn\u00fc ba\u015fka bir kurulu\u015fa yapt\u0131rabilirsiniz.\nAncak bu durum \u00fcretici rol\u00fcn\u00fcn getirdi\u011fi mevzuat y\u00fck\u00fcml\u00fcl\u00fcklerini\nortadan kald\u0131rmaz.\n<\/p>\n\n<p>\n\u00d6rne\u011fin s\u00f6zle\u015fmeli \u00fcretim yapt\u0131r\u0131yorsan\u0131z;\n<\/p>\n\n<ul>\n<li>tedarik\u00e7i se\u00e7imi,<\/li>\n<li>kalifikasyon,<\/li>\n<li>kalite s\u00f6zle\u015fmeleri,<\/li>\n<li>de\u011fi\u015fiklik kontrol\u00fc,<\/li>\n<li>\u00fcr\u00fcn kabul kriterleri,<\/li>\n<li>\u00fcretim kay\u0131tlar\u0131na eri\u015fim,<\/li>\n<li>uygunsuzluk y\u00f6netimi,<\/li>\n<li>izlenebilirlik<\/li>\n<\/ul>\n\n<p>\nKYS i\u00e7erisinde y\u00f6netilmelidir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>Fason \u00fcretim yapt\u0131rmak \u2260 sorumlulu\u011fu fason \u00fcreticiye b\u0131rakmak.<\/strong>\n<p>\nEtikette imalat\u00e7\u0131 olarak sizin \u015firketiniz bulunuyorsa ve \u00fcr\u00fcn sizin ad\u0131n\u0131z\nveya markan\u0131z alt\u0131nda piyasaya arz ediliyorsa \u00fcretici y\u00fck\u00fcml\u00fcl\u00fckleri\na\u00e7\u0131s\u0131ndan buna uygun bir yap\u0131 kurman\u0131z gerekir.\n<\/p>\n<\/div>\n\n<h2>19. Kendi Markan\u0131zla Haz\u0131r Bir Cihaz\u0131 Satarsan\u0131z Ne Olur?<\/h2>\n\n<p>\nBa\u015fka bir \u00fcreticinin \u00fcr\u00fcn\u00fcn\u00fc al\u0131p kendi markan\u0131z alt\u0131nda sat\u0131\u015fa sunmay\u0131\nplanl\u0131yorsan\u0131z MDR Madde 16 ayr\u0131ca de\u011ferlendirilmelidir.\n<\/p>\n\n<p>\nBelirli ko\u015fullarda;\n<\/p>\n\n<ul>\n<li>cihaz\u0131 kendi ad\u0131n\u0131z\/markan\u0131z alt\u0131nda piyasada bulundurman\u0131z,<\/li>\n<li>cihaz\u0131n kullan\u0131m amac\u0131n\u0131 de\u011fi\u015ftirmeniz veya<\/li>\n<li>uygunlu\u011fu etkileyebilecek \u015fekilde cihaz\u0131 modifiye etmeniz<\/li>\n<\/ul>\n\n<p>\nimalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fcklerini \u00fcstlenmenize neden olabilir.\n<\/p>\n\n<p>\nBu nedenle private-label t\u0131bbi cihaz projesi yaln\u0131zca ambalaj ve logo\ntasar\u0131m\u0131 olarak ele al\u0131nmamal\u0131d\u0131r.\n<\/p>\n\n<h2 id=\"pms\">20. CE Ald\u0131ktan Sonra \u00dcreticinin \u0130\u015fi Bitiyor mu?<\/h2>\n\n<p>\n<strong>Hay\u0131r.<\/strong>\n<\/p>\n\n<p>\nMDR&#8217;nin temel yakla\u015f\u0131m\u0131 cihaz\u0131n b\u00fct\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fcn izlenmesidir.\n<\/p>\n\n<p>\n\u00dcreticinin piyasaya arz sonras\u0131nda da;\n<\/p>\n\n<ul>\n<li>PMS sistemi,<\/li>\n<li>PMCF uygulan\u0131yorsa ilgili \u00e7al\u0131\u015fmalar,<\/li>\n<li>\u015fik\u00e2yet y\u00f6netimi,<\/li>\n<li>vigilance,<\/li>\n<li>trend raporlamas\u0131,<\/li>\n<li>CAPA,<\/li>\n<li>geri \u00e7a\u011f\u0131rma,<\/li>\n<li>saha g\u00fcvenli\u011fi d\u00fczeltici faaliyetleri,<\/li>\n<li>risk y\u00f6netiminin g\u00fcncellenmesi,<\/li>\n<li>klinik de\u011ferlendirmenin g\u00fcncellenmesi,<\/li>\n<li>teknik dosya g\u00fcncelli\u011fi<\/li>\n<\/ul>\n\n<p>\ngibi s\u00fcre\u00e7leri y\u00f6netmesi gerekir.\n<\/p>\n\n<p>\nPMS ve vigilance hakk\u0131nda\n<a href=\"\/en\/post-market-surveillance-pms-ve-vigilance-sureci-mdr-uyumunda-kritik-adimlar\/\">\n<strong>Post-Market Surveillance ve Vigilance Rehberimizi<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2>21. \u00dcretici \u00dcr\u00fcnde De\u011fi\u015fiklik Yaparsa Ne Olur?<\/h2>\n\n<p>\nCE i\u015fareti al\u0131nm\u0131\u015f olmas\u0131 \u00fcr\u00fcn\u00fcn bundan sonra istedi\u011finiz \u015fekilde\nde\u011fi\u015ftirilebilece\u011fi anlam\u0131na gelmez.\n<\/p>\n\n<p>\u00d6rne\u011fin;<\/p>\n\n<ul>\n<li>hammadde de\u011fi\u015fikli\u011fi,<\/li>\n<li>kritik tedarik\u00e7i de\u011fi\u015fikli\u011fi,<\/li>\n<li>\u00fcretim prosesi de\u011fi\u015fikli\u011fi,<\/li>\n<li>yaz\u0131l\u0131m g\u00fcncellemesi,<\/li>\n<li>sterilizasyon de\u011fi\u015fikli\u011fi,<\/li>\n<li>ambalaj de\u011fi\u015fikli\u011fi,<\/li>\n<li>ama\u00e7lanan kullan\u0131m de\u011fi\u015fikli\u011fi,<\/li>\n<li>\u00fcr\u00fcn tasar\u0131m\u0131nda de\u011fi\u015fiklik<\/li>\n<\/ul>\n\n<p>\nyap\u0131ld\u0131\u011f\u0131nda de\u011fi\u015fikli\u011fin \u00fcr\u00fcn uygunlu\u011funa etkisi de\u011ferlendirilmelidir.\n<\/p>\n\n<p>\nGerekirse risk analizi, validasyon, klinik de\u011ferlendirme,\nteknik dosya, etiket ve d\u00fczenleyici kay\u0131tlar g\u00fcncellenmelidir.\n<\/p>\n\n<h2>22. T\u0131bbi Cihaz \u00dcretmek \u0130\u00e7in Fabrika Ruhsat\u0131 Gerekir mi?<\/h2>\n\n<p>\n\u201cT\u0131bbi cihaz \u00fcretim ruhsat\u0131\u201d \u015feklinde b\u00fct\u00fcn t\u0131bbi cihaz \u00fcreticilerine\ntek ba\u015f\u0131na uygulanan ve CE s\u00fcrecinin yerine ge\u00e7en genel bir belge\nbulundu\u011funu d\u00fc\u015f\u00fcnmek do\u011fru de\u011fildir.\n<\/p>\n\n<p>\nAncak \u00fcretim tesisinin;\n<\/p>\n\n<ul>\n<li>i\u015fyeri a\u00e7ma ve \u00e7al\u0131\u015fma,<\/li>\n<li>belediye,<\/li>\n<li>\u00e7evre,<\/li>\n<li>i\u015f sa\u011fl\u0131\u011f\u0131 ve g\u00fcvenli\u011fi,<\/li>\n<li>yang\u0131n,<\/li>\n<li>at\u0131k y\u00f6netimi<\/li>\n<\/ul>\n\n<p>\ngibi genel y\u00fck\u00fcml\u00fcl\u00fcklerinin yan\u0131nda \u00fcretilecek cihaz ve kullan\u0131lan\nteknolojiye g\u00f6re \u00f6zel mevzuat gereklilikleri de bulunabilir.\n<\/p>\n\n<p>\n\u00d6rne\u011fin steril \u00fcretim, radyasyon kaynaklar\u0131, \u00f6zel kimyasallar veya\nbelirli \u00fcretim prosesleri ilave y\u00fck\u00fcml\u00fcl\u00fckler olu\u015fturabilir.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>CE ile i\u015fyeri ruhsat\u0131n\u0131 kar\u0131\u015ft\u0131rmay\u0131n.<\/strong>\n<p>\nCE \u00fcr\u00fcn\u00fcn uygunlu\u011fuyla ilgilidir. \u0130\u015fyerinin\/faaliyetin ilgili yerel ve\nsekt\u00f6rel izinleri ise ayr\u0131 mevzuatlar\u0131n konusudur.\n<\/p>\n<\/div>\n\n<h2 id=\"maliyet\">T\u0131bbi Cihaz \u00dcreticisi Olman\u0131n Maliyeti Ne Kadar?<\/h2>\n\n<p>\nBu soruya b\u00fct\u00fcn \u00fcr\u00fcnler i\u00e7in ge\u00e7erli sabit bir rakam vermek m\u00fcmk\u00fcn de\u011fildir.\n<\/p>\n\n<p>Maliyeti belirleyen ba\u015fl\u0131ca unsurlar;<\/p>\n\n<ul>\n<li>\u00fcr\u00fcn\u00fcn risk s\u0131n\u0131f\u0131,<\/li>\n<li>\u00fcr\u00fcn \u00e7e\u015fidi ve varyant say\u0131s\u0131,<\/li>\n<li>\u00fcretim tesisi ihtiyac\u0131,<\/li>\n<li>fason \u00fcretim modeli,<\/li>\n<li>laboratuvar testleri,<\/li>\n<li>validasyonlar,<\/li>\n<li>klinik kan\u0131t ihtiyac\u0131,<\/li>\n<li>ISO 13485\/KYS altyap\u0131s\u0131,<\/li>\n<li>Onaylanm\u0131\u015f Kurulu\u015f ihtiyac\u0131,<\/li>\n<li>UDI, kay\u0131t ve belgelendirme maliyetleri<\/li>\n<\/ul>\n\n<p>\ntaraf\u0131ndan belirlenir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>\u00dcr\u00fcn\u00fcn s\u0131n\u0131f\u0131n\u0131 belirlemeden b\u00fct\u00e7e \u00e7\u0131karmak yan\u0131lt\u0131c\u0131 olabilir.<\/strong>\n<p>\nNormal bir Class I cihaz projesi ile Class IIb veya Class III cihaz\nprojesinin test, klinik kan\u0131t, denetim ve uygunluk de\u011ferlendirme\nmaliyetleri ayn\u0131 de\u011fildir.\n<\/p>\n<\/div>\n\n<h2>T\u0131bbi Cihaz \u00dcreticisi Olma S\u00fcreci Ad\u0131m Ad\u0131m<\/h2>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Ad\u0131m<\/th>\n<th>Ne yap\u0131l\u0131r?<\/th>\n<th>Ana \u00e7\u0131kt\u0131<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr><td>1<\/td><td>\u00dcr\u00fcn fikri ve ama\u00e7lanan kullan\u0131m<\/td><td>\u00dcr\u00fcn tan\u0131m\u0131<\/td><\/tr>\n<tr><td>2<\/td><td>Mevzuat kapsam\u0131<\/td><td>T\u0131bbi cihaz\/IVD\/di\u011fer kapsam<\/td><\/tr>\n<tr><td>3<\/td><td>S\u0131n\u0131fland\u0131rma<\/td><td>Risk s\u0131n\u0131f\u0131<\/td><\/tr>\n<tr><td>4<\/td><td>Uygunluk stratejisi<\/td><td>CE\/NB yolu<\/td><\/tr>\n<tr><td>5<\/td><td>KYS<\/td><td>MDR uyumlu kalite sistemi<\/td><\/tr>\n<tr><td>6<\/td><td>PRRC<\/td><td>Nitelikli sorumlu ki\u015fi<\/td><\/tr>\n<tr><td>7<\/td><td>Risk y\u00f6netimi<\/td><td>Risk y\u00f6netim dosyas\u0131<\/td><\/tr>\n<tr><td>8<\/td><td>Tasar\u0131m ve \u00fcretim<\/td><td>Kontroll\u00fc \u00fcr\u00fcn\/proses<\/td><\/tr>\n<tr><td>9<\/td><td>Test ve validasyon<\/td><td>Do\u011frulama kan\u0131tlar\u0131<\/td><\/tr>\n<tr><td>10<\/td><td>Klinik de\u011ferlendirme<\/td><td>Klinik kan\u0131t<\/td><\/tr>\n<tr><td>11<\/td><td>Teknik dosya<\/td><td>Annex II-III dok\u00fcmantasyonu<\/td><\/tr>\n<tr><td>12<\/td><td>Etiket ve IFU<\/td><td>Piyasaya arz bilgileri<\/td><\/tr>\n<tr><td>13<\/td><td>Onaylanm\u0131\u015f Kurulu\u015f gerekiyorsa<\/td><td>Uygunluk de\u011ferlendirmesi<\/td><\/tr>\n<tr><td>14<\/td><td>Uygunluk Beyan\u0131<\/td><td>EU Declaration of Conformity<\/td><\/tr>\n<tr><td>15<\/td><td>CE<\/td><td>CE i\u015fareti<\/td><\/tr>\n<tr><td>16<\/td><td>UDI<\/td><td>Basic UDI-DI \/ UDI-DI yap\u0131s\u0131<\/td><\/tr>\n<tr><td>17<\/td><td>EUDAMED<\/td><td>Akt\u00f6r ve cihaz kay\u0131tlar\u0131<\/td><\/tr>\n<tr><td>18<\/td><td>T\u00fcrkiye<\/td><td>\u00dcTS ve uygulanabilir firma kay\u0131tlar\u0131<\/td><\/tr>\n<tr><td>19<\/td><td>Piyasaya arz<\/td><td>Ticari \u00fcr\u00fcn<\/td><\/tr>\n<tr><td>20<\/td><td>PMS<\/td><td>Ya\u015fam d\u00f6ng\u00fcs\u00fc izleme<\/td><\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<h2 id=\"kontrol\">T\u0131bbi Cihaz \u00dcretimine Ba\u015flamadan \u00d6nce 20 Soruluk Kontrol Listesi<\/h2>\n\n<div class=\"kk-check\">\n<ol>\n<li>\u00dcr\u00fcn\u00fcn ama\u00e7lanan kullan\u0131m\u0131 a\u00e7\u0131k \u015fekilde tan\u0131mland\u0131 m\u0131?<\/li>\n<li>\u00dcr\u00fcn\u00fcn ger\u00e7ekten t\u0131bbi cihaz oldu\u011fu do\u011fruland\u0131 m\u0131?<\/li>\n<li>MDR mi IVDR mi uygulanaca\u011f\u0131 belirlendi mi?<\/li>\n<li>Risk s\u0131n\u0131f\u0131 ve s\u0131n\u0131fland\u0131rma kural\u0131 belirlendi mi?<\/li>\n<li>Onaylanm\u0131\u015f Kurulu\u015f ihtiyac\u0131 belirlendi mi?<\/li>\n<li>\u00dcr\u00fcn\u00fc kim tasarlayacak?<\/li>\n<li>\u00dcr\u00fcn\u00fc kim \u00fcretecek?<\/li>\n<li>Etikette imalat\u00e7\u0131 olarak hangi t\u00fczel\/ger\u00e7ek ki\u015fi yer alacak?<\/li>\n<li>Fason \u00fcretim varsa kalite sorumluluklar\u0131 yaz\u0131l\u0131 m\u0131?<\/li>\n<li>MDR uyumlu KYS kuruldu mu?<\/li>\n<li>PRRC ihtiyac\u0131 ve uygun ki\u015fi belirlendi mi?<\/li>\n<li>Risk y\u00f6netim sistemi olu\u015fturuldu mu?<\/li>\n<li>GSPR de\u011ferlendirmesi yap\u0131ld\u0131 m\u0131?<\/li>\n<li>Gerekli test ve validasyonlar belirlendi mi?<\/li>\n<li>Klinik de\u011ferlendirme stratejisi olu\u015fturuldu mu?<\/li>\n<li>Teknik dok\u00fcmantasyon yap\u0131s\u0131 kuruldu mu?<\/li>\n<li>Etiket ve IFU planland\u0131 m\u0131?<\/li>\n<li>UDI yap\u0131s\u0131 belirlendi mi?<\/li>\n<li>EUDAMED\/\u00dcTS kay\u0131t stratejisi olu\u015fturuldu mu?<\/li>\n<li>PMS ve \u00fcr\u00fcn de\u011fi\u015fiklik y\u00f6netimi planland\u0131 m\u0131?<\/li>\n<\/ol>\n<\/div>\n\n<div class=\"kk-cta\">\n<h2>T\u0131bbi Cihaz \u00dcretimine Nereden Ba\u015flamal\u0131s\u0131n\u0131z?<\/h2>\n\n<p>\nHen\u00fcz \u00fcr\u00fcn geli\u015ftirme a\u015famas\u0131ndaysan\u0131z \u00f6nce \u00fcr\u00fcn\u00fcn\u00fcz\u00fcn mevzuat kapsam\u0131n\u0131,\nrisk s\u0131n\u0131f\u0131n\u0131 ve uygunluk de\u011ferlendirme yolunu belirleyin.\nTeknik dosya ve kalite sistemini \u00fcr\u00fcn geli\u015ftirme tamamland\u0131ktan sonraya b\u0131rakmay\u0131n.\n<\/p>\n\n<a href=\"\/en\/tibbi-cihaz-siniflandirma-araci\/\">Cihaz S\u0131n\u0131f\u0131n\u0131 Belirle<\/a>\n<a href=\"\/en\/tibbi-cihaz-ce-belgesi-nasil-alinir\/\">CE S\u00fcrecini \u0130ncele<\/a>\n<a href=\"\/en\/mdr-teknik-dosya-kontrol-kit\/\">Teknik Dosyay\u0131 Kontrol Et<\/a>\n<a href=\"\/en\/iletisim\/\">KaliteKit ile \u0130leti\u015fime Ge\u00e7<\/a>\n<\/div>\n\n<h2 id=\"sss\">T\u0131bbi Cihaz \u00dcreticisi Olmak Hakk\u0131nda S\u0131k Sorulan Sorular<\/h2>\n\n<div class=\"kk-faq\">\n<h3>T\u0131bbi cihaz \u00fcretmek i\u00e7in \u015firket kurmak zorunlu mu?<\/h3>\n<p>\nT\u0131bbi Cihaz Y\u00f6netmeli\u011fi imalat\u00e7\u0131y\u0131 ger\u00e7ek veya t\u00fczel ki\u015fi olarak tan\u0131mlar.\nBununla birlikte \u00fcr\u00fcn\u00fcn ticari \u015fekilde \u00fcretilmesi ve piyasaya arz\u0131nda vergi,\nticaret, i\u015fyeri ve di\u011fer ulusal y\u00fck\u00fcml\u00fcl\u00fckler ayr\u0131ca uygulan\u0131r.\nBu nedenle yaln\u0131zca MDR&#8217;deki imalat\u00e7\u0131 tan\u0131m\u0131 \u00fczerinden ticari kurulu\u015f\ngerekliliklerinin bulunmad\u0131\u011f\u0131 sonucu \u00e7\u0131kar\u0131lmamal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>\u00dcr\u00fcn\u00fc ba\u015fka bir firmaya \u00fcrettirirsem \u00fcretici kim olur?<\/h3>\n<p>\nCihaz\u0131 ba\u015fka bir firmaya tasarlatman\u0131z veya \u00fcrettirmeniz m\u00fcmk\u00fcnd\u00fcr.\nCihaz kendi ad\u0131n\u0131z veya ticari markan\u0131z alt\u0131nda piyasaya arz ediliyorsa\nmevzuattaki imalat\u00e7\u0131 tan\u0131m\u0131 ve y\u00fck\u00fcml\u00fcl\u00fckleri sizin firman\u0131z a\u00e7\u0131s\u0131ndan\nde\u011ferlendirilmelidir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Fabrikam olmadan t\u0131bbi cihaz \u00fcreticisi olabilir miyim?<\/h3>\n<p>\nEvet. Mevzuattaki imalat\u00e7\u0131 tan\u0131m\u0131 b\u00fct\u00fcn fiziksel \u00fcretim i\u015flemlerinin\n\u00fcreticinin kendi tesisinde yap\u0131lmas\u0131n\u0131 \u015fart ko\u015fmaz. Ancak d\u0131\u015f kaynakl\u0131\n\u00fcretim ve kritik tedarik\u00e7iler KYS kapsam\u0131nda kontrol edilmeli ve\nimalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fckleri kar\u015f\u0131lanmal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>T\u0131bbi cihaz \u00fcretmek i\u00e7in ISO 13485 belgesi zorunlu mu?<\/h3>\n<p>\nMDR imalat\u00e7\u0131ya uygun bir kalite y\u00f6netim sistemi kurma y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc getirir.\nISO 13485 bu sistem i\u00e7in temel ve yayg\u0131n standartt\u0131r; ancak her cihaz ve\nher uygunluk de\u011ferlendirme yolu i\u00e7in ayr\u0131 bir ISO 13485 sertifikas\u0131n\u0131n\n\u00f6n ko\u015ful oldu\u011fu \u015feklinde genel bir MDR h\u00fckm\u00fc yoktur.\nT\u00fcrkiye&#8217;deki sat\u0131\u015f merkezi d\u00fczenlemelerinde yurt i\u00e7i imalat\u00e7\u0131 ba\u015fvuru\nsahiplerini ilgilendiren yeni EN ISO 13485 belge \u015fart\u0131 ise\n1 Ocak 2027&#8217;de y\u00fcr\u00fcrl\u00fc\u011fe girecektir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Class I cihaz \u00fcreticisi ISO 13485 sistemi kurmal\u0131 m\u0131?<\/h3>\n<p>\nClass I olmas\u0131 MDR Madde 10(9)&#8217;daki KYS y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn\u00fc ortadan kald\u0131rmaz.\nNormal Class I cihazda Onaylanm\u0131\u015f Kurulu\u015f kat\u0131l\u0131m\u0131 genel olarak bulunmasa da\n\u00fcretici mevzuata uygun bir kalite y\u00f6netim sistemini s\u00fcrd\u00fcrmelidir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>T\u0131bbi cihaz \u00fcreticisinin PRRC&#8217;si olmak zorunda m\u0131?<\/h3>\n<p>\nEvet. MDR Madde 15 kapsam\u0131nda \u00fcreticilerin gerekli uzmanl\u0131\u011fa sahip en az\nbir PRRC&#8217;ye sahip olmas\u0131 gerekir. Mikro ve k\u00fc\u00e7\u00fck i\u015fletmelerde ki\u015fi \u015firket\n\u00e7al\u0131\u015fan\u0131 olmak zorunda olmayabilir ancak s\u00fcrekli ve devaml\u0131 eri\u015filebilir olmal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Her t\u0131bbi cihaz i\u00e7in Onaylanm\u0131\u015f Kurulu\u015f gerekli mi?<\/h3>\n<p>\nHay\u0131r. Normal Class I cihazlarda genel olarak Onaylanm\u0131\u015f Kurulu\u015f kat\u0131l\u0131m\u0131\nbulunmaz. Class Is, Im ve Ir cihazlarda ilgili \u00f6zel alanlar a\u00e7\u0131s\u0131ndan;\nClass IIa, IIb ve III cihazlarda ise uygulanabilir uygunluk de\u011ferlendirme\nyoluna g\u00f6re Onaylanm\u0131\u015f Kurulu\u015f kat\u0131l\u0131m\u0131 gerekir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Yaz\u0131l\u0131m \u015firketi t\u0131bbi cihaz \u00fcreticisi olabilir mi?<\/h3>\n<p>\nEvet. Yaz\u0131l\u0131m belirli t\u0131bbi ama\u00e7lar\u0131 kar\u015f\u0131l\u0131yorsa medical device software\nolarak MDR kapsam\u0131na girebilir. Yaz\u0131l\u0131m\u0131 kendi ad\u0131 veya markas\u0131 alt\u0131nda\npiyasaya sunan firma da imalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fcklerine tabi olabilir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Kendi markam\u0131 haz\u0131r medikal \u00fcr\u00fcn\u00fcn \u00fczerine koyabilir miyim?<\/h3>\n<p>\nBu i\u015flem yaln\u0131zca marka de\u011fi\u015fikli\u011fi olarak g\u00f6r\u00fclmemelidir.\nMDR Madde 16 kapsam\u0131nda cihaz\u0131 kendi ad\u0131n\u0131z veya markan\u0131z alt\u0131nda piyasada\nbulundurman\u0131z belirli durumlarda imalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fcklerini \u00fcstlenmenize yol a\u00e7abilir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>T\u0131bbi cihaz \u00fcreticisinin \u00dcTS kayd\u0131 gerekir mi?<\/h3>\n<p>\nT\u00fcrkiye&#8217;de piyasaya arz edilecek cihazlar a\u00e7\u0131s\u0131ndan \u00fcreticinin ve \u00fcr\u00fcnlerin\n\u00dcTS kay\u0131t gereklilikleri ayr\u0131ca de\u011ferlendirilmelidir. CE uygunlu\u011fu ile \u00dcTS\nkayd\u0131 birbirinden farkl\u0131 ancak ba\u011flant\u0131l\u0131 s\u00fcre\u00e7lerdir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>EUDAMED cihaz kayd\u0131 zorunlu mu?<\/h3>\n<p>\nEUDAMED&#8217;in UDI\/Device mod\u00fcl\u00fcn\u00fcn zorunlu kullan\u0131m\u0131 28 May\u0131s 2026&#8217;da\nba\u015flam\u0131\u015ft\u0131r. AB pazar\u0131na cihaz sunan \u00fcreticiler a\u00e7\u0131s\u0131ndan uygulanabilir\ncihaz kay\u0131t y\u00fck\u00fcml\u00fcl\u00fckleri g\u00fcncel EUDAMED ge\u00e7i\u015f h\u00fck\u00fcmleriyle birlikte\nde\u011ferlendirilmelidir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>CE belgesi al\u0131nd\u0131ktan sonra \u00fcreticinin sorumlulu\u011fu biter mi?<\/h3>\n<p>\nHay\u0131r. \u00dcreticinin PMS, vigilance, \u015fik\u00e2yet, risk y\u00f6netimi, klinik de\u011ferlendirme,\nCAPA, geri \u00e7a\u011f\u0131rma, teknik dosya g\u00fcncelli\u011fi ve de\u011fi\u015fiklik y\u00f6netimi gibi\ny\u00fck\u00fcml\u00fcl\u00fckleri \u00fcr\u00fcn\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca devam eder.\n<\/p>\n<\/div>\n\n<h2>Sonu\u00e7: \u00d6nce \u00dcretici Rol\u00fcn\u00fc Kurun, Sonra \u00dcr\u00fcn\u00fc Piyasaya \u00c7\u0131kar\u0131n<\/h2>\n\n<p>\n<strong>T\u0131bbi cihaz \u00fcreticisi olmak i\u00e7in ne gerekir?<\/strong> sorusunun cevab\u0131\nyaln\u0131zca \u00fcretim tesisi kurmak veya CE logosunu \u00fcr\u00fcne eklemek de\u011fildir.\n<\/p>\n\n<p>\nDo\u011fru s\u00fcre\u00e7;\n<\/p>\n\n<div class=\"kk-flow\">\n<span>\u00dcr\u00fcn Fikri<\/span>\n<span>\u2192<\/span>\n<span>Ama\u00e7lanan Kullan\u0131m<\/span>\n<span>\u2192<\/span>\n<span>S\u0131n\u0131fland\u0131rma<\/span>\n<span>\u2192<\/span>\n<span>KYS<\/span>\n<span>\u2192<\/span>\n<span>PRRC<\/span>\n<span>\u2192<\/span>\n<span>Risk<\/span>\n<span>\u2192<\/span>\n<span>Teknik Dosya<\/span>\n<span>\u2192<\/span>\n<span>Klinik<\/span>\n<span>\u2192<\/span>\n<span>Test<\/span>\n<span>\u2192<\/span>\n<span>CE<\/span>\n<span>\u2192<\/span>\n<span>UDI<\/span>\n<span>\u2192<\/span>\n<span>EUDAMED \/ \u00dcTS<\/span>\n<span>\u2192<\/span>\n<span>PMS<\/span>\n<\/div>\n\n<p>\n\u015feklinde ya\u015fam d\u00f6ng\u00fcs\u00fc yakla\u015f\u0131m\u0131yla kurulmal\u0131d\u0131r.\n<\/p>\n\n<p>\n\u00d6zellikle ilk kez t\u0131bbi cihaz geli\u015ftiren firmalar\u0131n mevzuat \u00e7al\u0131\u015fmas\u0131n\u0131\n\u00fcr\u00fcn geli\u015ftirme bittikten sonra ba\u015flatmak yerine tasar\u0131m\u0131n ilk a\u015famalar\u0131ndan\nitibaren s\u00fcrece dahil etmesi hem zaman hem de maliyet a\u00e7\u0131s\u0131ndan \u00f6nemli\navantaj sa\u011flayabilir.\n<\/p>\n\n<hr>\n\n<section class=\"kk-source\">\n\n<h2>Mevzuat ve Kaynaklar<\/h2>\n\n<p>\nBu rehber ba\u015fta T\u0131bbi Cihaz Y\u00f6netmeli\u011fi ve Regulation (EU) 2017\/745 (MDR)\nolmak \u00fczere g\u00fcncel t\u0131bbi cihaz mevzuat\u0131 temel al\u0131narak haz\u0131rlanm\u0131\u015ft\u0131r.\n<\/p>\n\n<ul>\n<li>T\u0131bbi Cihaz Y\u00f6netmeli\u011fi \u2013 \u0130malat\u00e7\u0131 tan\u0131m\u0131 ve Madde 10 imalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fckleri<\/li>\n<li>MDR 2017\/745 \u2013 Article 2, Article 10, Article 15, Article 16<\/li>\n<li>MDR Annex I \u2013 General Safety and Performance Requirements<\/li>\n<li>MDR Annex II ve Annex III \u2013 Technical Documentation<\/li>\n<li>MDR Annex VIII \u2013 Classification Rules<\/li>\n<li>MDCG 2019-15 Rev.1 \u2013 Class I Medical Device Manufacturers Guidance<\/li>\n<li>European Commission \u2013 Manufacturers of Medical Devices<\/li>\n<li>European Commission \u2013 EUDAMED Actor ve UDI\/Device Registration<\/li>\n<\/ul>\n\n<p>\n<strong>Son g\u00f6zden ge\u00e7irme:<\/strong> 14 Eyl\u00fcl 2026\n<\/p>\n\n<p>\n<strong>Bilgilendirme:<\/strong>\nBu i\u00e7erik genel bilgilendirme amac\u0131yla haz\u0131rlanm\u0131\u015ft\u0131r.\n\u00dcretim tesisi izinleri, belediye\/i\u015fyeri ruhsatlar\u0131, \u00e7evre ve i\u015f g\u00fcvenli\u011fi\ny\u00fck\u00fcml\u00fcl\u00fckleri ile \u00fcr\u00fcn grubuna \u00f6zg\u00fc izinler \u00fcretim teknolojisine ve\nfaaliyetin niteli\u011fine g\u00f6re ayr\u0131ca de\u011ferlendirilmelidir.\n<\/p>\n\n<\/section>\n\n<\/article>","protected":false},"excerpt":{"rendered":"<p>T\u0131bbi cihaz \u00fcreticisi olmak, yaln\u0131zca bir \u00fcr\u00fcn tasarlay\u0131p \u00fcretime ba\u015flamak anlam\u0131na gelmez. \u00dcr\u00fcn\u00fcn t\u0131bbi cihaz niteli\u011finin belirlenmesi, risk s\u0131n\u0131f\u0131n\u0131n tespit [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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