MDR IIa\u2013IIb Cihaz \u00dcreticileri \u0130\u00e7in Uyum Rehberi | Kalitekit<\/title>\n\n \n <meta name=\"description\" content=\"IIa ve IIb s\u0131n\u0131f\u0131 t\u0131bbi cihaz \u00fcreticileri i\u00e7in MDR uyum s\u00fcreci, teknik dosya gereklilikleri, klinik de\u011ferlendirme, risk y\u00f6netimi, PMCF ve PSUR s\u00fcre\u00e7lerini kapsayan kapsaml\u0131 rehber.\">\n <meta name=\"keywords\" content=\"MDR, 2017\/745, IIa cihaz, IIb cihaz, MDR teknik dosya, klinik de\u011ferlendirme, CER, PMCF, PSUR, ISO 14971, UDI, t\u0131bbi cihaz mevzuat\u0131, Kalitekit\">\n <link rel=\"canonical\" href=\"https:\/\/www.kalitekit.com.tr\/mdr-iia-iib-ureticileri-icin-uyum-rehberi\/\">\n\n \n <script type=\"application\/ld+json\">\n {\n \"@context\": \"https:\/\/schema.org\",\n \"@type\": \"Article\",\n \"headline\": \"MDR IIa\u2013IIb Cihaz \u00dcreticileri \u0130\u00e7in Uyum Rehberi\",\n \"description\": \"IIa ve IIb s\u0131n\u0131f\u0131 t\u0131bbi cihaz \u00fcreticileri i\u00e7in MDR uyumlulu\u011fu, klinik de\u011ferlendirme, risk y\u00f6netimi, PMCF ve teknik dosya gerekliliklerini i\u00e7eren detayl\u0131 rehber.\",\n \"author\": {\n \"@type\": \"Organization\",\n \"name\": \"Kalitekit Dan\u0131\u015fmanl\u0131k\"\n },\n \"publisher\": {\n \"@type\": \"Organization\",\n \"name\": \"Kalitekit\",\n \"logo\": {\n \"@type\": \"ImageObject\",\n \"url\": \"https:\/\/www.kalitekit.com.tr\/logo.png\"\n }\n },\n \"mainEntityOfPage\": \"https:\/\/www.kalitekit.com.tr\/mdr-iia-iib-ureticileri-icin-uyum-rehberi\/\",\n \"datePublished\": \"2025-11-23\"\n }\n <\/script>\n\n<style>\nbody {font-family: Arial, sans-serif; line-height: 1.7; color:#222;}\nh1,h2,h3 {color:#0d3c61;}\nstrong {color:#0d3c61;}\nblockquote {border-left:4px solid #0d3c61; padding-left:12px; margin-left:0;}\n<\/style>\n\n<\/head>\n\n<body>\n\n<article>\n\n<h1>MDR Yolculu\u011fu: IIa\u2013IIb S\u0131n\u0131f\u0131 T\u0131bbi Cihaz \u00dcreticileri \u0130\u00e7in Ayr\u0131nt\u0131l\u0131 Uyum Rehberi<\/h1>\n\n<p>\nAvrupa Birli\u011fi\u2019nin 2017\/745 say\u0131l\u0131 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR), t\u0131bbi cihaz \u00fcreticilerinin sorumluluklar\u0131n\u0131 yaln\u0131zca belgelendirme a\u015famas\u0131ndan \u00e7\u0131kar\u0131p, \nt\u00fcm \u00fcr\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fc kapsayan bir sisteme d\u00f6n\u00fc\u015ft\u00fcrd\u00fc. \u00d6zellikle IIa ve IIb s\u0131n\u0131f\u0131 cihaz \u00fcreticileri i\u00e7in bu s\u00fcre\u00e7; teknik, klinik ve d\u00fczenleyici a\u00e7\u0131dan yeni bir disiplin anlam\u0131na geliyor.\n<\/p>\n\n<hr>\n\n<h2>MDR\u2019nin Kapsam\u0131 ve \u00dcreticiye Getirdi\u011fi Temel Y\u00fck\u00fcml\u00fcl\u00fckler<\/h2>\n\n<p>\nMDR, cihazlar\u0131n hem g\u00fcvenli\u011fini hem de performans\u0131n\u0131 g\u00fc\u00e7l\u00fc kan\u0131tlarla desteklemeyi zorunlu k\u0131lar. Y\u00f6netmeli\u011fin ana amac\u0131:\n<\/p>\n\n<ul>\n<li>Cihaz\u0131n klinik performans\u0131n\u0131n do\u011frulanmas\u0131,<\/li>\n<li>Risklerin s\u00fcrekli de\u011ferlendirilmesi,<\/li>\n<li>\u0130zlenebilirli\u011fi sa\u011flayan UDI yap\u0131s\u0131n\u0131n kurulmas\u0131,<\/li>\n<li>Piyasaya sunulan \u00fcr\u00fcnlerin ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca izlenmesi,<\/li>\n<li>Teknik dosyada tutarl\u0131 ve g\u00fcncel verilerin bulunmas\u0131d\u0131r.<\/li>\n<\/ul>\n\n<p>\nIIa\u2013IIb \u00fcreticileri i\u00e7in bu gereklilikler, yaln\u0131zca \u00fcretim de\u011fil; planlama, veri y\u00f6netimi ve post-market s\u00fcre\u00e7lerinde de g\u00fc\u00e7l\u00fc bir sistem kurulmas\u0131n\u0131 gerektirir.\n<\/p>\n\n<hr>\n\n<h2>IIa ve IIb S\u0131n\u0131f\u0131 \u00dcreticiler \u0130\u00e7in MDR’nin Getirdi\u011fi Yeni Ger\u00e7eklik<\/h2>\n\n<p>\nOrta risk s\u0131n\u0131f\u0131ndaki cihazlar, y\u00f6netmeli\u011fin en s\u0131k\u0131 b\u00f6l\u00fcmleriyle do\u011frudan ili\u015fkilidir. Bu nedenle:\n<\/p>\n\n<ul>\n<li>Daha kapsaml\u0131 klinik veri,<\/li>\n<li>Daha derinlemesine risk analizi,<\/li>\n<li>Daha ayr\u0131nt\u0131l\u0131 teknik dosya,<\/li>\n<li>G\u00fc\u00e7l\u00fc post-market mekanizmalar\u0131<\/li>\n<\/ul>\n\n<p>bu s\u0131n\u0131ftaki \u00fcreticiler i\u00e7in zorunlu hale gelmi\u015ftir.<\/p>\n\n<hr>\n\n<h2>Teknik Dosyan\u0131n MDR\u2019ye Uygun Haz\u0131rlanmas\u0131<\/h2>\n\n<p>\nBir teknik dosyan\u0131n MDR\u2019ye uygun olmas\u0131 i\u00e7in a\u015fa\u011f\u0131daki ana b\u00f6l\u00fcmlerin do\u011fru bir \u015fekilde ele al\u0131nmas\u0131 gerekir:\n<\/p>\n\n<h3>Cihaz Tan\u0131m\u0131<\/h3>\n<p>\nCihaz\u0131n amac\u0131, \u00e7al\u0131\u015fma prensibi, varyantlar\u0131 ve kullan\u0131m alanlar\u0131 a\u00e7\u0131k ve teknik bir dille tan\u0131mlanmal\u0131d\u0131r. T\u00fcm teknik dosya bu tan\u0131m ile tutarl\u0131 olmak zorundad\u0131r.\n<\/p>\n\n<h3>Risk Y\u00f6netimi Dosyas\u0131<\/h3>\n<p>\nISO 14971 ve ISO\/TR 24971 rehberli\u011finde haz\u0131rlanmal\u0131d\u0131r. \nHer tehlike kayna\u011f\u0131 i\u00e7in riskler belirlenmeli, kontrol \u00f6nlemleri tan\u0131mlanmal\u0131 ve t\u00fcm kalan riskler klinik veriyle do\u011frulanmal\u0131d\u0131r.\n<\/p>\n\n<h3>Klinik De\u011ferlendirme (CER)<\/h3>\n<p>\nMDR, klinik veri konusunda y\u00fcksek bir beklentiye sahiptir.\nCihazla ilgili klinik literat\u00fcr, e\u015fde\u011fer cihaz kar\u015f\u0131la\u015ft\u0131rmalar\u0131, performans verileri ve g\u00fcvenlik verilerinin uyumlu \u015fekilde sunulmas\u0131 gerekir.\n<\/p>\n\n<ul>\n<li>Teknik e\u015fde\u011ferlik<\/li>\n<li>Biyolojik \/ malzeme e\u015fde\u011ferli\u011fi<\/li>\n<li>Klinik e\u015fde\u011ferlik<\/li>\n<\/ul>\n\n<p>\u00fc\u00e7\u00fc de kan\u0131tlanmal\u0131d\u0131r.<\/p>\n\n<h3>Test Raporlar\u0131 ve Standart Uygunlu\u011fu<\/h3>\n<p>\nSterilizasyon validasyonlar\u0131, paketleme testleri, biyouyumluluk seti ve performans testleri teknik dosyan\u0131n zorunlu par\u00e7alar\u0131d\u0131r.\n<\/p>\n\n<h3>UDI \u2013 Etiket \u2013 \u0130zlenebilirlik<\/h3>\n<p>\nBasic UDI-DI dahil t\u00fcm UDI hiyerar\u015fisi teknik dosyada tan\u0131ml\u0131 olmal\u0131, etiket ve IFU ile birebir uyumlu olmal\u0131d\u0131r.\n<\/p>\n\n<hr>\n\n<h2>Post-Market S\u00fcre\u00e7leri: MDR\u2019nin En \u00d6nemli B\u00f6l\u00fcm\u00fc<\/h2>\n\n<h3>PMS (Piyasaya Arz Sonras\u0131 G\u00f6zetim)<\/h3>\n<p>\nCihaz piyasadayken toplanan t\u00fcm performans ve g\u00fcvenlik verileri PMS plan\u0131na g\u00f6re de\u011ferlendirilir.\n<\/p>\n\n<h3>PMCF (Piyasaya Arz Sonras\u0131 Klinik Takip)<\/h3>\n<p>\nCihaz\u0131n ger\u00e7ek kullan\u0131m ko\u015fullar\u0131ndaki klinik performans\u0131 PMCF \u00e7al\u0131\u015fmalar\u0131 ile do\u011frulan\u0131r. \nAnketler, kullan\u0131c\u0131 geri bildirimleri, klinik veri analizleri PMCF kapsam\u0131nda yer alabilir ancak yaln\u0131z ba\u015f\u0131na yeterli de\u011fildir.\n<\/p>\n\n<h3>PSUR (Y\u0131ll\u0131k G\u00fcvenlik Raporu)<\/h3>\n<p>\nIIa ve IIb s\u0131n\u0131f\u0131 t\u00fcm cihazlar i\u00e7in PSUR zorunludur. \nBu rapor cihaz\u0131n risk-fayda dengesinin hala korunup korunmad\u0131\u011f\u0131n\u0131 g\u00f6sterir.\n<\/p>\n\n<hr>\n\n<h2>MDR Denetimlerinde En S\u0131k G\u00f6r\u00fclen Uygunsuzluklar<\/h2>\n\n<ul>\n<li>Klinik verinin cihaz iddialar\u0131n\u0131 desteklememesi,<\/li>\n<li>Risk y\u00f6netimi ile CER aras\u0131nda uyumsuzluk,<\/li>\n<li>Test raporlar\u0131n\u0131n eksik olmas\u0131,<\/li>\n<li>UDI bilgilerinin etiketteki verilerle \u00e7eli\u015fmesi,<\/li>\n<li>PMCF planlar\u0131n\u0131n y\u00fczeysel haz\u0131rlanmas\u0131,<\/li>\n<li>IFU ile teknik dosya aras\u0131ndaki tutars\u0131zl\u0131klar.<\/li>\n<\/ul>\n\n<p>\nBu uygunsuzluklar\u0131n \u00e7o\u011fu, \u00fcreticilerin s\u00fcre\u00e7 bazl\u0131 de\u011fil belge bazl\u0131 \u00e7al\u0131\u015fmas\u0131ndan kaynaklan\u0131r.\n<\/p>\n\n<hr>\n\n<h2>MDR Uyumunda Ba\u015far\u0131n\u0131n 3 Temel \u015eart\u0131<\/h2>\n\n<h3>1. Tutarl\u0131l\u0131k<\/h3>\n<p>\nTeknik dosya, CER, risk y\u00f6netimi, IFU ve PMS belgeleri birbirini desteklemelidir.\n<\/p>\n\n<h3>2. G\u00fcncellik<\/h3>\n<p>\nHer klinik g\u00fcncelleme veya her PMS sonucu teknik dosyaya i\u015flenmelidir.\n<\/p>\n\n<h3>3. Sistematik Yakla\u015f\u0131m<\/h3>\n<p>\nMDR uyumu yaln\u0131zca belge haz\u0131rlamak de\u011fil; \u00fcretim, tedarik, tasar\u0131m ve izlenebilirlik s\u00fcre\u00e7lerini y\u00f6netmek anlam\u0131na gelir.\n<\/p>\n\n<hr>\n\n<h2>Sonu\u00e7: MDR Zorlu Bir S\u00fcre\u00e7tir, Ancak Do\u011fru Bir Y\u00f6netimle Avantaja D\u00f6n\u00fc\u015febilir<\/h2>\n\n<p>\nIIa ve IIb s\u0131n\u0131f\u0131 cihaz \u00fcreticileri i\u00e7in MDR, ba\u015flang\u0131\u00e7ta a\u011f\u0131r bir y\u00fck gibi g\u00f6r\u00fcnse de uzun vadede \u00fcreticiye \u00f6nemli avantajlar sa\u011flar:\n<\/p>\n\n<ul>\n<li>G\u00fcvenlik ve performans\u0131n belgelenmesi,<\/li>\n<li>Denetim riskinin azalmas\u0131,<\/li>\n<li>Uluslararas\u0131 pazarda kabul edilebilirlik,<\/li>\n<li>Distrib\u00fct\u00f6r ve hastane prestijinin artmas\u0131.<\/li>\n<\/ul>\n\n<p>\nDo\u011fru y\u00f6netilen bir MDR s\u00fcreci, bir \u00fcreticiyi rakiplerinden birka\u00e7 ad\u0131m ileri ta\u015f\u0131r. \nKalite y\u00f6netimi, klinik veri ve teknik dosya bir araya geldi\u011finde g\u00fc\u00e7l\u00fc bir reg\u00fclasyon altyap\u0131s\u0131 olu\u015fur.\n<\/p>\n\n<\/article>\n\n<\/body>\n<\/html>\n\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Avrupa Birli\u011fi\u2019nin 2017\/745 say\u0131l\u0131 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR), t\u0131bbi cihaz \u00fcreticilerinin sorumluluklar\u0131n\u0131 yaln\u0131zca belgelendirme a\u015famas\u0131ndan \u00e7\u0131kar\u0131p, t\u00fcm \u00fcr\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fc kapsayan bir sisteme d\u00f6n\u00fc\u015ft\u00fcrd\u00fc. \u00d6zellikle IIa ve IIb s\u0131n\u0131f\u0131 cihaz \u00fcreticileri i\u00e7in bu s\u00fcre\u00e7; teknik, klinik ve d\u00fczenleyici a\u00e7\u0131dan yeni bir disiplin anlam\u0131na geliyor.<\/p>","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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[122],"tags":[],"class_list":["post-10108","post","type-post","status-publish","format-standard","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/10108","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=10108"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/10108\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=10108"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=10108"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=10108"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

{"id":10108,"date":"2025-11-23T16:32:09","date_gmt":"2025-11-23T16:32:09","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=10108"},"modified":"2025-11-23T16:32:17","modified_gmt":"2025-11-23T16:32:17","slug":"mdr-yolculugu-iia-iib-sinifi-tibbi-cihaz-ureticileri-icin-ayrintili-uyum-rehberi","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/mdr-yolculugu-iia-iib-sinifi-tibbi-cihaz-ureticileri-icin-ayrintili-uyum-rehberi\/","title":{"rendered":"MDR Yolculu\u011fu: IIa\u2013IIb S\u0131n\u0131f\u0131 T\u0131bbi Cihaz \u00dcreticileri \u0130\u00e7in Ayr\u0131nt\u0131l\u0131 Uyum Rehberi"},"content":{"rendered":"\n\n\n \n \n MDR IIa\u2013IIb Cihaz \u00dcreticileri \u0130\u00e7in Uyum Rehberi | Kalitekit<\/title>\n\n \n <meta name=\"description\" content=\"IIa ve IIb s\u0131n\u0131f\u0131 t\u0131bbi cihaz \u00fcreticileri i\u00e7in MDR uyum s\u00fcreci, teknik dosya gereklilikleri, klinik de\u011ferlendirme, risk y\u00f6netimi, PMCF ve PSUR s\u00fcre\u00e7lerini kapsayan kapsaml\u0131 rehber.\">\n <meta name=\"keywords\" content=\"MDR, 2017\/745, IIa cihaz, IIb cihaz, MDR teknik dosya, klinik de\u011ferlendirme, CER, PMCF, PSUR, ISO 14971, UDI, t\u0131bbi cihaz mevzuat\u0131, Kalitekit\">\n <link rel=\"canonical\" href=\"https:\/\/www.kalitekit.com.tr\/mdr-iia-iib-ureticileri-icin-uyum-rehberi\/\">\n\n \n <script type=\"application\/ld+json\">\n {\n \"@context\": \"https:\/\/schema.org\",\n \"@type\": \"Article\",\n \"headline\": \"MDR IIa\u2013IIb Cihaz \u00dcreticileri \u0130\u00e7in Uyum Rehberi\",\n \"description\": \"IIa ve IIb s\u0131n\u0131f\u0131 t\u0131bbi cihaz \u00fcreticileri i\u00e7in MDR uyumlulu\u011fu, klinik de\u011ferlendirme, risk y\u00f6netimi, PMCF ve teknik dosya gerekliliklerini i\u00e7eren detayl\u0131 rehber.\",\n \"author\": {\n \"@type\": \"Organization\",\n \"name\": \"Kalitekit Dan\u0131\u015fmanl\u0131k\"\n },\n \"publisher\": {\n \"@type\": \"Organization\",\n \"name\": \"Kalitekit\",\n \"logo\": {\n \"@type\": \"ImageObject\",\n \"url\": \"https:\/\/www.kalitekit.com.tr\/logo.png\"\n }\n },\n \"mainEntityOfPage\": \"https:\/\/www.kalitekit.com.tr\/mdr-iia-iib-ureticileri-icin-uyum-rehberi\/\",\n \"datePublished\": \"2025-11-23\"\n }\n <\/script>\n\n<style>\nbody {font-family: Arial, sans-serif; line-height: 1.7; color:#222;}\nh1,h2,h3 {color:#0d3c61;}\nstrong {color:#0d3c61;}\nblockquote {border-left:4px solid #0d3c61; padding-left:12px; margin-left:0;}\n<\/style>\n\n<\/head>\n\n<body>\n\n<article>\n\n<h1>MDR Yolculu\u011fu: IIa\u2013IIb S\u0131n\u0131f\u0131 T\u0131bbi Cihaz \u00dcreticileri \u0130\u00e7in Ayr\u0131nt\u0131l\u0131 Uyum Rehberi<\/h1>\n\n<p>\nAvrupa Birli\u011fi\u2019nin 2017\/745 say\u0131l\u0131 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR), t\u0131bbi cihaz \u00fcreticilerinin sorumluluklar\u0131n\u0131 yaln\u0131zca belgelendirme a\u015famas\u0131ndan \u00e7\u0131kar\u0131p, \nt\u00fcm \u00fcr\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fc kapsayan bir sisteme d\u00f6n\u00fc\u015ft\u00fcrd\u00fc. \u00d6zellikle IIa ve IIb s\u0131n\u0131f\u0131 cihaz \u00fcreticileri i\u00e7in bu s\u00fcre\u00e7; teknik, klinik ve d\u00fczenleyici a\u00e7\u0131dan yeni bir disiplin anlam\u0131na geliyor.\n<\/p>\n\n<hr>\n\n<h2>MDR\u2019nin Kapsam\u0131 ve \u00dcreticiye Getirdi\u011fi Temel Y\u00fck\u00fcml\u00fcl\u00fckler<\/h2>\n\n<p>\nMDR, cihazlar\u0131n hem g\u00fcvenli\u011fini hem de performans\u0131n\u0131 g\u00fc\u00e7l\u00fc kan\u0131tlarla desteklemeyi zorunlu k\u0131lar. Y\u00f6netmeli\u011fin ana amac\u0131:\n<\/p>\n\n<ul>\n<li>Cihaz\u0131n klinik performans\u0131n\u0131n do\u011frulanmas\u0131,<\/li>\n<li>Risklerin s\u00fcrekli de\u011ferlendirilmesi,<\/li>\n<li>\u0130zlenebilirli\u011fi sa\u011flayan UDI yap\u0131s\u0131n\u0131n kurulmas\u0131,<\/li>\n<li>Piyasaya sunulan \u00fcr\u00fcnlerin ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca izlenmesi,<\/li>\n<li>Teknik dosyada tutarl\u0131 ve g\u00fcncel verilerin bulunmas\u0131d\u0131r.<\/li>\n<\/ul>\n\n<p>\nIIa\u2013IIb \u00fcreticileri i\u00e7in bu gereklilikler, yaln\u0131zca \u00fcretim de\u011fil; planlama, veri y\u00f6netimi ve post-market s\u00fcre\u00e7lerinde de g\u00fc\u00e7l\u00fc bir sistem kurulmas\u0131n\u0131 gerektirir.\n<\/p>\n\n<hr>\n\n<h2>IIa ve IIb S\u0131n\u0131f\u0131 \u00dcreticiler \u0130\u00e7in MDR’nin Getirdi\u011fi Yeni Ger\u00e7eklik<\/h2>\n\n<p>\nOrta risk s\u0131n\u0131f\u0131ndaki cihazlar, y\u00f6netmeli\u011fin en s\u0131k\u0131 b\u00f6l\u00fcmleriyle do\u011frudan ili\u015fkilidir. Bu nedenle:\n<\/p>\n\n<ul>\n<li>Daha kapsaml\u0131 klinik veri,<\/li>\n<li>Daha derinlemesine risk analizi,<\/li>\n<li>Daha ayr\u0131nt\u0131l\u0131 teknik dosya,<\/li>\n<li>G\u00fc\u00e7l\u00fc post-market mekanizmalar\u0131<\/li>\n<\/ul>\n\n<p>bu s\u0131n\u0131ftaki \u00fcreticiler i\u00e7in zorunlu hale gelmi\u015ftir.<\/p>\n\n<hr>\n\n<h2>Teknik Dosyan\u0131n MDR\u2019ye Uygun Haz\u0131rlanmas\u0131<\/h2>\n\n<p>\nBir teknik dosyan\u0131n MDR\u2019ye uygun olmas\u0131 i\u00e7in a\u015fa\u011f\u0131daki ana b\u00f6l\u00fcmlerin do\u011fru bir \u015fekilde ele al\u0131nmas\u0131 gerekir:\n<\/p>\n\n<h3>Cihaz Tan\u0131m\u0131<\/h3>\n<p>\nCihaz\u0131n amac\u0131, \u00e7al\u0131\u015fma prensibi, varyantlar\u0131 ve kullan\u0131m alanlar\u0131 a\u00e7\u0131k ve teknik bir dille tan\u0131mlanmal\u0131d\u0131r. T\u00fcm teknik dosya bu tan\u0131m ile tutarl\u0131 olmak zorundad\u0131r.\n<\/p>\n\n<h3>Risk Y\u00f6netimi Dosyas\u0131<\/h3>\n<p>\nISO 14971 ve ISO\/TR 24971 rehberli\u011finde haz\u0131rlanmal\u0131d\u0131r. \nHer tehlike kayna\u011f\u0131 i\u00e7in riskler belirlenmeli, kontrol \u00f6nlemleri tan\u0131mlanmal\u0131 ve t\u00fcm kalan riskler klinik veriyle do\u011frulanmal\u0131d\u0131r.\n<\/p>\n\n<h3>Klinik De\u011ferlendirme (CER)<\/h3>\n<p>\nMDR, klinik veri konusunda y\u00fcksek bir beklentiye sahiptir.\nCihazla ilgili klinik literat\u00fcr, e\u015fde\u011fer cihaz kar\u015f\u0131la\u015ft\u0131rmalar\u0131, performans verileri ve g\u00fcvenlik verilerinin uyumlu \u015fekilde sunulmas\u0131 gerekir.\n<\/p>\n\n<ul>\n<li>Teknik e\u015fde\u011ferlik<\/li>\n<li>Biyolojik \/ malzeme e\u015fde\u011ferli\u011fi<\/li>\n<li>Klinik e\u015fde\u011ferlik<\/li>\n<\/ul>\n\n<p>\u00fc\u00e7\u00fc de kan\u0131tlanmal\u0131d\u0131r.<\/p>\n\n<h3>Test Raporlar\u0131 ve Standart Uygunlu\u011fu<\/h3>\n<p>\nSterilizasyon validasyonlar\u0131, paketleme testleri, biyouyumluluk seti ve performans testleri teknik dosyan\u0131n zorunlu par\u00e7alar\u0131d\u0131r.\n<\/p>\n\n<h3>UDI \u2013 Etiket \u2013 \u0130zlenebilirlik<\/h3>\n<p>\nBasic UDI-DI dahil t\u00fcm UDI hiyerar\u015fisi teknik dosyada tan\u0131ml\u0131 olmal\u0131, etiket ve IFU ile birebir uyumlu olmal\u0131d\u0131r.\n<\/p>\n\n<hr>\n\n<h2>Post-Market S\u00fcre\u00e7leri: MDR\u2019nin En \u00d6nemli B\u00f6l\u00fcm\u00fc<\/h2>\n\n<h3>PMS (Piyasaya Arz Sonras\u0131 G\u00f6zetim)<\/h3>\n<p>\nCihaz piyasadayken toplanan t\u00fcm performans ve g\u00fcvenlik verileri PMS plan\u0131na g\u00f6re de\u011ferlendirilir.\n<\/p>\n\n<h3>PMCF (Piyasaya Arz Sonras\u0131 Klinik Takip)<\/h3>\n<p>\nCihaz\u0131n ger\u00e7ek kullan\u0131m ko\u015fullar\u0131ndaki klinik performans\u0131 PMCF \u00e7al\u0131\u015fmalar\u0131 ile do\u011frulan\u0131r. \nAnketler, kullan\u0131c\u0131 geri bildirimleri, klinik veri analizleri PMCF kapsam\u0131nda yer alabilir ancak yaln\u0131z ba\u015f\u0131na yeterli de\u011fildir.\n<\/p>\n\n<h3>PSUR (Y\u0131ll\u0131k G\u00fcvenlik Raporu)<\/h3>\n<p>\nIIa ve IIb s\u0131n\u0131f\u0131 t\u00fcm cihazlar i\u00e7in PSUR zorunludur. \nBu rapor cihaz\u0131n risk-fayda dengesinin hala korunup korunmad\u0131\u011f\u0131n\u0131 g\u00f6sterir.\n<\/p>\n\n<hr>\n\n<h2>MDR Denetimlerinde En S\u0131k G\u00f6r\u00fclen Uygunsuzluklar<\/h2>\n\n<ul>\n<li>Klinik verinin cihaz iddialar\u0131n\u0131 desteklememesi,<\/li>\n<li>Risk y\u00f6netimi ile CER aras\u0131nda uyumsuzluk,<\/li>\n<li>Test raporlar\u0131n\u0131n eksik olmas\u0131,<\/li>\n<li>UDI bilgilerinin etiketteki verilerle \u00e7eli\u015fmesi,<\/li>\n<li>PMCF planlar\u0131n\u0131n y\u00fczeysel haz\u0131rlanmas\u0131,<\/li>\n<li>IFU ile teknik dosya aras\u0131ndaki tutars\u0131zl\u0131klar.<\/li>\n<\/ul>\n\n<p>\nBu uygunsuzluklar\u0131n \u00e7o\u011fu, \u00fcreticilerin s\u00fcre\u00e7 bazl\u0131 de\u011fil belge bazl\u0131 \u00e7al\u0131\u015fmas\u0131ndan kaynaklan\u0131r.\n<\/p>\n\n<hr>\n\n<h2>MDR Uyumunda Ba\u015far\u0131n\u0131n 3 Temel \u015eart\u0131<\/h2>\n\n<h3>1. Tutarl\u0131l\u0131k<\/h3>\n<p>\nTeknik dosya, CER, risk y\u00f6netimi, IFU ve PMS belgeleri birbirini desteklemelidir.\n<\/p>\n\n<h3>2. G\u00fcncellik<\/h3>\n<p>\nHer klinik g\u00fcncelleme veya her PMS sonucu teknik dosyaya i\u015flenmelidir.\n<\/p>\n\n<h3>3. Sistematik Yakla\u015f\u0131m<\/h3>\n<p>\nMDR uyumu yaln\u0131zca belge haz\u0131rlamak de\u011fil; \u00fcretim, tedarik, tasar\u0131m ve izlenebilirlik s\u00fcre\u00e7lerini y\u00f6netmek anlam\u0131na gelir.\n<\/p>\n\n<hr>\n\n<h2>Sonu\u00e7: MDR Zorlu Bir S\u00fcre\u00e7tir, Ancak Do\u011fru Bir Y\u00f6netimle Avantaja D\u00f6n\u00fc\u015febilir<\/h2>\n\n<p>\nIIa ve IIb s\u0131n\u0131f\u0131 cihaz \u00fcreticileri i\u00e7in MDR, ba\u015flang\u0131\u00e7ta a\u011f\u0131r bir y\u00fck gibi g\u00f6r\u00fcnse de uzun vadede \u00fcreticiye \u00f6nemli avantajlar sa\u011flar:\n<\/p>\n\n<ul>\n<li>G\u00fcvenlik ve performans\u0131n belgelenmesi,<\/li>\n<li>Denetim riskinin azalmas\u0131,<\/li>\n<li>Uluslararas\u0131 pazarda kabul edilebilirlik,<\/li>\n<li>Distrib\u00fct\u00f6r ve hastane prestijinin artmas\u0131.<\/li>\n<\/ul>\n\n<p>\nDo\u011fru y\u00f6netilen bir MDR s\u00fcreci, bir \u00fcreticiyi rakiplerinden birka\u00e7 ad\u0131m ileri ta\u015f\u0131r. \nKalite y\u00f6netimi, klinik veri ve teknik dosya bir araya geldi\u011finde g\u00fc\u00e7l\u00fc bir reg\u00fclasyon altyap\u0131s\u0131 olu\u015fur.\n<\/p>\n\n<\/article>\n\n<\/body>\n<\/html>\n\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Avrupa Birli\u011fi\u2019nin 2017\/745 say\u0131l\u0131 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR), t\u0131bbi cihaz \u00fcreticilerinin sorumluluklar\u0131n\u0131 yaln\u0131zca belgelendirme a\u015famas\u0131ndan \u00e7\u0131kar\u0131p, t\u00fcm \u00fcr\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fc kapsayan bir sisteme d\u00f6n\u00fc\u015ft\u00fcrd\u00fc. \u00d6zellikle IIa ve IIb s\u0131n\u0131f\u0131 cihaz \u00fcreticileri i\u00e7in bu s\u00fcre\u00e7; teknik, klinik ve d\u00fczenleyici a\u00e7\u0131dan yeni bir disiplin anlam\u0131na geliyor.<\/p>","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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[122],"tags":[],"class_list":["post-10108","post","type-post","status-publish","format-standard","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/10108","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=10108"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/10108\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=10108"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=10108"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=10108"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}