{"id":9325,"date":"2025-10-04T14:40:03","date_gmt":"2025-10-04T14:40:03","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=9325"},"modified":"2025-10-04T14:46:24","modified_gmt":"2025-10-04T14:46:24","slug":"mdcg-trend-raporu-icin-taslak-kilavuz-yayinladi","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/mdcg-trend-raporu-icin-taslak-kilavuz-yayinladi\/","title":{"rendered":"MDCG Trend Raporu \u0130\u00e7in Taslak K\u0131lavuz Yay\u0131nlad\u0131"},"content":{"rendered":"<!-- SEO Meta -->\n<title>MDCG Trend Raporu \u0130\u00e7in Taslak K\u0131lavuz Yay\u0131nlad\u0131 | KaliteKit<\/title>\n<meta name=\"description\" content=\"MDCG, MDR Madde 88 ve IVDR Madde 83 kapsam\u0131nda Trend Raporlama rehberini taslak olarak yay\u0131mlad\u0131. EUDAMED dijital raporlama, PMS entegrasyonu ve MTR format\u0131 detaylar\u0131 burada.\">\n<meta name=\"keywords\" content=\"MDR, IVDR, Trend Report, EUDAMED, Medical Devices, PMS, CAPA, FSCA, MDCG rehberi\">\n\n<!-- Blog \u0130\u00e7eri\u011fi -->\n<article class=\"blog-post\">\n  <h1>MDCG Trend Raporu \u0130\u00e7in Taslak K\u0131lavuz Yay\u0131nlad\u0131<\/h1>\n  <p><strong>Yay\u0131n Tarihi:<\/strong> Ekim 2025 | <strong>Yazar:<\/strong> KaliteKit Edit\u00f6r Ekibi<\/p>\n\n  <h2>\ud83e\udded Giri\u015f<\/h2>\n  <p>Avrupa Komisyonu\u2019nun <strong>Medical Device Coordination Group (MDCG)<\/strong> birimi, <strong>MDR (EU 2017\/745) Madde 88<\/strong> ve <strong>IVDR (EU 2017\/746) Madde 83<\/strong> kapsam\u0131nda <strong>Trend Raporlama (Trend Reporting)<\/strong> s\u00fcrecine ili\u015fkin <strong>taslak k\u0131lavuzunu<\/strong> yay\u0131mlad\u0131.<\/p>\n  <p>Bu yeni rehber, \u00fcreticilerin <strong>Post-Market Surveillance (PMS)<\/strong> s\u00fcre\u00e7lerinde trend analizi uygulamalar\u0131n\u0131 standartla\u015ft\u0131rmak ve g\u00fcvenlik sinyallerinin erken tespitini g\u00fc\u00e7lendirmeyi ama\u00e7l\u0131yor.<\/p>\n\n  <h2>\ud83d\udd0d Taslak K\u0131lavuzda \u00d6ne \u00c7\u0131kan Noktalar<\/h2>\n\n  <h3>1\ufe0f\u20e3 MTR (Manufacturer Trend Report) Format\u0131<\/h3>\n  <p>Yeni taslakta, \u00fcreticilerin sunaca\u011f\u0131 <strong>MTR formlar\u0131n\u0131n format\u0131 ve i\u00e7eri\u011fi<\/strong> detayl\u0131 \u015fekilde tan\u0131mland\u0131. Bu format, hem <em>beklenen istenmeyen yan etkiler (expected undesirable side effects)<\/em> hem de <em>beklenen yanl\u0131\u015f sonu\u00e7lar (expected erroneous results)<\/em> i\u00e7in ayr\u0131 kategoriler i\u00e7eriyor.<\/p>\n\n  <h3>2\ufe0f\u20e3 Raporlama E\u015fiklerinin Netle\u015ftirilmesi<\/h3>\n  <p>K\u0131lavuz, <strong>trend raporlamas\u0131n\u0131n ne zaman zorunlu olaca\u011f\u0131na<\/strong> dair a\u00e7\u0131k e\u015fik tan\u0131mlar\u0131 sunuyor. Belirli bir olay tipi belirli bir zaman diliminde istatistiksel art\u0131\u015f g\u00f6sterdi\u011finde Trend Report haz\u0131rlanmas\u0131 gerekiyor.<\/p>\n\n  <h3>3\ufe0f\u20e3 EUDAMED \u00dczerinden Dijital Sunum<\/h3>\n  <p><strong>EUDAMED sistemi<\/strong> \u00fczerinden dijital raporlama s\u00fcreci a\u015famal\u0131 olarak ba\u015flat\u0131lacak. Ge\u00e7i\u015f s\u00fcrecinde \u00fcreticiler <strong>manuel olarak Competent Authority\u2019lere<\/strong> rapor sunacak. EUDAMED\u2019in tam olarak devreye girmesinden <strong>6 ay sonra dijital sunum zorunlu<\/strong> hale gelecek.<\/p>\n\n  <h3>4\ufe0f\u20e3 PMS, QMS, CAPA ve FSCA Entegrasyonu<\/h3>\n  <p>Trend raporlamas\u0131n\u0131n, \u00fcreticinin <strong>PMS plan\u0131<\/strong>, <strong>QMS dok\u00fcmantasyonu<\/strong>, <strong>CAPA<\/strong> ve <strong>FSCA<\/strong> s\u00fcre\u00e7leriyle entegre \u015fekilde y\u00fcr\u00fct\u00fclmesi gerekti\u011fi vurgulan\u0131yor. B\u00f6ylece e\u011filimler do\u011frudan <strong>risk y\u00f6netimi<\/strong> ve <strong>d\u00fczeltici faaliyetlere<\/strong> yans\u0131t\u0131labiliyor.<\/p>\n\n  <h2>\u2699\ufe0f \u00dcreticiler \u0130\u00e7in Ne Anlama Geliyor?<\/h2>\n  <p>Bu taslak rehber, \u00f6zellikle <strong>MDR ve IVDR<\/strong> kapsam\u0131nda faaliyet g\u00f6steren \u00fcreticiler i\u00e7in \u00f6nemli bir uyar\u0131 niteli\u011fi ta\u015f\u0131yor. Firmalar\u0131n, \u015fimdiden a\u015fa\u011f\u0131daki ad\u0131mlar\u0131 planlamas\u0131 \u00f6nerilir:<\/p>\n  <ul>\n    <li>Trend rapor formatlar\u0131n\u0131 QMS s\u00fcre\u00e7lerine dahil etmek,<\/li>\n    <li>EUDAMED veri entegrasyonuna haz\u0131rl\u0131k yapmak,<\/li>\n    <li>PMS planlar\u0131n\u0131 MDCG rehberine g\u00f6re g\u00fcncellemek.<\/li>\n  <\/ul>\n  <p>Bu haz\u0131rl\u0131klar, <strong>CE i\u015faretinin s\u00fcrd\u00fcr\u00fclebilirli\u011fi<\/strong> ve <strong>d\u00fczenleyici uygunlu\u011fun korunmas\u0131<\/strong> a\u00e7\u0131s\u0131ndan b\u00fcy\u00fck \u00f6nem ta\u015f\u0131r.<\/p>\n\n  <h2>\ud83e\udde9 KaliteKit Ne Sunuyor?<\/h2>\n  <p>KaliteKit olarak, \u00fcreticilere \u00f6zel <strong>Trend Raporlama ara\u00e7lar\u0131<\/strong>, <strong>PMS plan \u015fablonlar\u0131<\/strong> ve <strong>EUDAMED entegrasyon \u00e7\u00f6z\u00fcmleri<\/strong> geli\u015ftiriyoruz. Yak\u0131nda yay\u0131mlanacak <strong>Trend Report Builder<\/strong> mod\u00fcl\u00fcm\u00fcz ile \u00fcreticiler:<\/p>\n  <ul>\n    <li>MTR formlar\u0131n\u0131 dijital olarak olu\u015fturabilecek,<\/li>\n    <li>Trend analizlerini grafiksel olarak g\u00f6r\u00fcnt\u00fcleyebilecek,<\/li>\n    <li>Raporlar\u0131n\u0131 yetkili otoritelere uygun formatta haz\u0131rlayabilecek.<\/li>\n  <\/ul>\n\n  <h2>\ud83d\udcda Referanslar<\/h2>\n  <ul>\n    <li>MDR (EU) 2017\/745 \u2013 Article 88<\/li>\n    <li>IVDR (EU) 2017\/746 \u2013 Article 83<\/li>\n    <li>MDCG Draft Guidance on Trend Reporting (Eyl\u00fcl 2025)<\/li>\n    <li>European Commission \u2013 EUDAMED Roadmap<\/li>\n  <\/ul>\n\n  <h2>\ud83d\udee1\ufe0f Sorumluluk Reddi (Disclaimer)<\/h2>\n  <p>Bu i\u00e7erik yaln\u0131zca <strong>bilgilendirme amac\u0131yla<\/strong> haz\u0131rlanm\u0131\u015ft\u0131r. Resm\u00ee mevzuat ve rehber yorumlar\u0131 i\u00e7in Avrupa Komisyonu\u2019nun g\u00fcncel yay\u0131nlar\u0131 takip edilmelidir. KaliteKit, bu bilgilerin kullan\u0131m\u0131ndan do\u011fabilecek yasal sorumluluklar\u0131 \u00fcstlenmez.<\/p>\n\n  <h2>\ud83d\udcc8 Sonu\u00e7<\/h2>\n  <p>MDCG\u2019nin yeni taslak k\u0131lavuzu, trend raporlamay\u0131 art\u0131k opsiyonel de\u011fil, <strong>stratejik bir PMS gereklili\u011fi<\/strong> haline getiriyor. \u00dcreticiler, bu s\u00fcre\u00e7leri erken benimseyerek hem <strong>d\u00fczenleyici riskleri azaltabilir<\/strong> hem de <strong>\u00fcr\u00fcn g\u00fcvenli\u011fini g\u00fc\u00e7lendirebilir.<\/strong><\/p>\n\n  <p><em>#MDR #IVDR #PMS #EUDAMED #MedicalDevices #TrendReport #KaliteKit<\/em><\/p>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>\u201cMDCG, MDR Madde 88 ve IVDR Madde 83 kapsam\u0131nda Trend Raporlama rehberini yay\u0131mlad\u0131. EUDAMED dijital raporlama s\u00fcreci ve MTR format\u0131 a\u00e7\u0131kland\u0131.\u201d<\/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":[294,295,296],"class_list":["post-9325","post","type-post","status-publish","format-standard","hentry","category-blog","tag-mdcg","tag-tibbicihaztrend","tag-trendanalizi"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/9325","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=9325"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/9325\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=9325"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=9325"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=9325"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}