{"id":9439,"date":"2025-10-10T13:30:24","date_gmt":"2025-10-10T13:30:24","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=9439"},"modified":"2025-10-10T13:30:31","modified_gmt":"2025-10-10T13:30:31","slug":"mdr-uyumlu-teknik-dosya-technical-documentation-hazirlama-rehberi","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/mdr-uyumlu-teknik-dosya-technical-documentation-hazirlama-rehberi\/","title":{"rendered":"MDR Uyumlu Teknik Dosya (Technical Documentation) Haz\u0131rlama Rehberi"},"content":{"rendered":"<h3 class=\"wp-block-heading\">\ud83d\udd0d 1. Giri\u015f: Teknik Dosya Neden Kritik?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">T\u0131bbi cihazlar\u0131n Avrupa Birli\u011fi pazar\u0131na arz\u0131, <strong>MDR (Regulation (EU) 2017\/745)<\/strong> y\u00f6netmeli\u011fine tam uyum gerektirir.<br>Bu y\u00f6netmeli\u011fin kalbinde yer alan <strong>Technical Documentation (Teknik Dosya)<\/strong>, cihaz\u0131n tasar\u0131m, \u00fcretim, test, risk y\u00f6netimi ve klinik performans\u0131na ili\u015fkin <strong>t\u00fcm kan\u0131tlar\u0131n izlenebilir bi\u00e7imde derlendi\u011fi<\/strong> ana dosyad\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Avrupa Komisyonu\u2019nun rehberine g\u00f6re (MDCG 2022-21):<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">\u201cThe technical documentation should demonstrate conformity of the device with the general safety and performance requirements set out in Annex I of the MDR.\u201d<br><em>(Kaynak: Medical Device Coordination Group Guidance, MDCG 2022-21)<\/em><\/p>\n<\/blockquote>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83e\udde9 2. Yasal Dayanak ve Referans Belgeler<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Teknik dosyan\u0131n i\u00e7eri\u011fi ve yap\u0131s\u0131 do\u011frudan MDR\u2019nin a\u015fa\u011f\u0131daki b\u00f6l\u00fcmleriyle tan\u0131mlan\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Annex II \u2013 Technical Documentation<\/strong><\/li>\n\n\n\n<li><strong>Annex III \u2013 Technical Documentation on Post-Market Surveillance<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ek olarak, dosya olu\u015fturulurken \u00fcreticiler a\u015fa\u011f\u0131daki standart ve k\u0131lavuzlara da ba\u015fvurmal\u0131d\u0131r:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Kaynak<\/th><th>Belge \/ Standart<\/th><th>A\u00e7\u0131klama<\/th><\/tr><\/thead><tbody><tr><td>Regulation (EU) 2017\/745<\/td><td>Annex II &amp; III<\/td><td>Dosya i\u00e7eri\u011fi ve format\u0131<\/td><\/tr><tr><td>ISO 13485:2016<\/td><td>4.2.3 &amp; 4.2.4<\/td><td>Dok\u00fcmantasyon yap\u0131s\u0131 ve kontrol\u00fc<\/td><\/tr><tr><td>ISO 14971:2019<\/td><td>T\u00fcm madde<\/td><td>Risk y\u00f6netimi entegrasyonu<\/td><\/tr><tr><td>MDCG 2022-21<\/td><td>Guidance on technical documentation<\/td><td>AB Komisyonu rehberi<\/td><\/tr><tr><td>MDCG 2020-13<\/td><td>Clinical evaluation assessment report<\/td><td>Klinik de\u011ferlendirme ba\u011flant\u0131s\u0131<\/td><\/tr><tr><td>MDCG 2021-24<\/td><td>Classification of devices<\/td><td>S\u0131n\u0131fland\u0131rma rehberi<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2699\ufe0f 3. Teknik Dosyan\u0131n Yap\u0131s\u0131 (MDR Annex II\u2019ye G\u00f6re)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A\u015fa\u011f\u0131daki tablo, MDR\u2019nin <strong>Annex II<\/strong> maddelerine uygun olarak dosya i\u00e7eri\u011fini \u00f6zetler:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>B\u00f6l\u00fcm<\/th><th>\u0130\u00e7erik<\/th><th>Referans<\/th><\/tr><\/thead><tbody><tr><td><strong>1. Cihaz Tan\u0131m\u0131 ve \u00dcr\u00fcn Bilgileri<\/strong><\/td><td>Cihaz\u0131n tan\u0131m\u0131, ticari ad\u0131, modeli, s\u0131n\u0131f\u0131, varyantlar\u0131, aksesuarlar\u0131, kullan\u0131m amac\u0131, hedef kullan\u0131c\u0131 ve hasta grubu.<\/td><td>MDR Annex II, 1(a)-(e)<\/td><\/tr><tr><td><strong>2. Etiketleme ve Kullan\u0131m Talimatlar\u0131 (IFU)<\/strong><\/td><td>Etiket \u00f6rnekleri, ambalaj i\u015faretlemeleri, semboller, kullan\u0131m k\u0131lavuzu (Instructions for Use).<\/td><td>MDR Annex II, 2<\/td><\/tr><tr><td><strong>3. Tasar\u0131m ve \u00dcretim Bilgileri<\/strong><\/td><td>\u00dcretim yeri, \u00fcretim prosesi, validasyon planlar\u0131, tedarik\u00e7i kontrolleri, sterilizasyon y\u00f6ntemleri.<\/td><td>MDR Annex II, 3<\/td><\/tr><tr><td><strong>4. Genel G\u00fcvenlik ve Performans Gereklilikleri (GSPR)<\/strong><\/td><td>Annex I\u2019deki her gereklili\u011fe kar\u015f\u0131l\u0131k gelen kan\u0131t tablosu (Conformity Matrix).<\/td><td>MDR Annex II, 4<\/td><\/tr><tr><td><strong>5. Risk Y\u00f6netimi<\/strong><\/td><td>ISO 14971\u2019e uygun risk analizi, kontrol \u00f6nlemleri ve risk\/yarar de\u011ferlendirmesi.<\/td><td>MDR Annex II, 4(a)<\/td><\/tr><tr><td><strong>6. Klinik De\u011ferlendirme (CER)<\/strong><\/td><td>Annex XIV\u2019e g\u00f6re haz\u0131rlanm\u0131\u015f Klinik De\u011ferlendirme Raporu (CER) ve PMCF belgeleri.<\/td><td>MDR Annex II, 6<\/td><\/tr><tr><td><strong>7. Do\u011frulama ve Validasyon Verileri<\/strong><\/td><td>Performans testleri, biyouyumluluk raporlar\u0131, yaz\u0131l\u0131m validasyonlar\u0131, sterilizasyon ve ya\u015fland\u0131rma testleri.<\/td><td>MDR Annex II, 6.1<\/td><\/tr><tr><td><strong>8. PMS ve Vigilance Dok\u00fcmanlar\u0131<\/strong><\/td><td>PMS Plan\u0131, PSUR veya PMS Raporu, olay bildirimleri ve CAPA kay\u0131tlar\u0131.<\/td><td>MDR Annex III<\/td><\/tr><tr><td><strong>9. Uygunluk Beyan\u0131 (DoC)<\/strong><\/td><td>Cihaz\u0131n MDR gerekliliklerini kar\u015f\u0131lad\u0131\u011f\u0131n\u0131 beyan eden, imzal\u0131 ve tarihli belge.<\/td><td>MDR Article 19<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83e\udde0 4. Teknik Dosya Haz\u0131rlama Ad\u0131mlar\u0131<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\">A. Dosya Haz\u0131rl\u0131k Plan\u0131<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 13485:2016 Madde 4.2.3 uyar\u0131nca, \u00fcretici teknik dosya i\u00e7in <strong>yap\u0131land\u0131r\u0131lm\u0131\u015f bir dok\u00fcmantasyon plan\u0131<\/strong> olu\u015fturmal\u0131d\u0131r.<br>Bu plan, dosyan\u0131n sorumlular\u0131n\u0131, revizyon s\u00fcrecini ve kalite kay\u0131tlar\u0131n\u0131 tan\u0131mlar.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">B. Kan\u0131t Toplama<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Her GSPR maddesine kar\u015f\u0131l\u0131k gelen test, rapor veya analiz dok\u00fcmanlar\u0131 toplan\u0131r.<br>\u00d6rne\u011fin:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>GSPR 10.2:<\/strong> Biyouyumluluk \u2192 <em>ISO 10993 test raporu<\/em><\/li>\n\n\n\n<li><strong>GSPR 11.5:<\/strong> Elektrik g\u00fcvenli\u011fi \u2192 <em>IEC 60601-1 test raporu<\/em><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">C. Dosya D\u00fczeni<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Avrupa Komisyonu, teknik dosyalar\u0131n <strong>dijital ortamda (eQMS veya PDF)<\/strong> d\u00fczenlenmesini ve a\u00e7\u0131k bir klas\u00f6r yap\u0131s\u0131 izlenmesini \u00f6nerir:<\/p>\n\n\n\n<pre class=\"wp-block-code\"><code>\/01_Device_Description  \n\/02_Labeling_IFU  \n\/03_Design_and_Manufacturing  \n\/04_GSPR_Checklist  \n\/05_Risk_Management  \n\/06_Clinical_Evaluation  \n\/07_Test_Reports  \n\/08_PMS_Documentation  \n\/09_Declaration_of_Conformity  \n<\/code><\/pre>\n\n\n\n<h4 class=\"wp-block-heading\">D. Revizyon ve Onay<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Her dok\u00fcman versiyon numaras\u0131, tarih, sorumlu ki\u015fi ve onaylayan ki\u015fi bilgilerini i\u00e7ermelidir.<br>Bu, ISO 13485 Madde 4.2.4 gere\u011fidir.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83e\uddfe 5. MDR Annex III\u2019e G\u00f6re PMS Entegrasyonu<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Teknik dosya, sadece tasar\u0131m ve \u00fcretim a\u015famas\u0131n\u0131 de\u011fil, <strong>\u00fcr\u00fcn piyasaya \u00e7\u0131kt\u0131ktan sonraki izlemesini<\/strong> de kapsar.<br>MDR Annex III bu b\u00f6l\u00fcm\u00fc tan\u0131mlar:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">\u201cThe manufacturer shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.\u201d<br><em>(MDR Annex III \u2013 Post-Market Surveillance System)<\/em><\/p>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">Bu kapsamda dosyada yer almas\u0131 gerekenler:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>PMS Plan\u0131 (Post-Market Surveillance Plan)<\/strong><\/li>\n\n\n\n<li><strong>PMS Raporu veya PSUR (Periodic Safety Update Report)<\/strong><\/li>\n\n\n\n<li><strong>Vigilance olay kay\u0131tlar\u0131<\/strong><\/li>\n\n\n\n<li><strong>CAPA ve trend analizleri<\/strong><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udccb 6. Denetim ve \u0130nceleme<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Notified Body (Onaylanm\u0131\u015f Kurulu\u015f), teknik dosyay\u0131 \u015fu kriterlere g\u00f6re de\u011ferlendirir:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Dosya yap\u0131s\u0131 MDR Annex II\u2019ye uygun mu?<\/li>\n\n\n\n<li>GSPR tablosundaki her gereklili\u011fin kan\u0131t\u0131 var m\u0131?<\/li>\n\n\n\n<li>Klinik veriler CER ile uyumlu mu?<\/li>\n\n\n\n<li>PMS ve risk y\u00f6netimi aras\u0131nda izlenebilirlik sa\u011flanm\u0131\u015f m\u0131?<\/li>\n\n\n\n<li>Dosya, kalite y\u00f6netim sistemiyle (ISO 13485) entegre mi?<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Eksiklikler genellikle \u201cMajor\u201d veya \u201cMinor Non-Conformity\u201d olarak raporlan\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udca1 7. Pratik \u0130pu\u00e7lar\u0131<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2705 Dosyay\u0131 <strong>Word, PDF veya eQMS format\u0131nda<\/strong> olu\u015ftur, ama tek kaynak versiyonunu belirle.<br>\u2705 GSPR tablosunda her maddeye kar\u015f\u0131l\u0131k <strong>test raporu veya dok\u00fcman referans\u0131<\/strong> ekle.<br>\u2705 CER, PMCF ve PMS belgelerini <strong>tek bir klinik mod\u00fcl<\/strong> alt\u0131nda topla.<br>\u2705 Revizyon ge\u00e7mi\u015fini tut, tarih bazl\u0131 kay\u0131t olu\u015ftur.<br>\u2705 Cihaz\u0131n \u201cUnique Device Identification (UDI)\u201d kodunu dosyaya ekle.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83e\udde9 8. Sonu\u00e7<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">MDR teknik dosyas\u0131, bir \u00fcretici i\u00e7in yaln\u0131zca yasal bir zorunluluk de\u011fil, ayn\u0131 zamanda \u00fcr\u00fcn\u00fcn g\u00fcvenli\u011fini ve kalitesini belgeleyen stratejik bir varl\u0131kt\u0131r.<br>D\u00fczenli olarak g\u00fcncellenen, izlenebilir ve standartlara uygun bir dosya:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CE belgelendirme s\u00fcrecini h\u0131zland\u0131r\u0131r,<\/li>\n\n\n\n<li>Denetimlerde g\u00fcven sa\u011flar,<\/li>\n\n\n\n<li>Marka itibar\u0131n\u0131 g\u00fc\u00e7lendirir.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udcda Resm\u00ee Kaynaklar<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulation (EU) 2017\/745 \u2013 Medical Devices Regulation (MDR)<\/strong><\/li>\n\n\n\n<li><strong>MDCG 2022-21 \u2013 Guidance on Technical Documentation<\/strong><\/li>\n\n\n\n<li><strong>ISO 13485:2016 \u2013 Medical Devices Quality Management Systems<\/strong><\/li>\n\n\n\n<li><strong>ISO 14971:2019 \u2013 Risk Management for Medical Devices<\/strong><\/li>\n\n\n\n<li><strong>MDCG 2020-13 \u2013 Clinical Evaluation Assessment Report<\/strong><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udccc Hashtag <\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">#MDR #TechnicalDocumentation #TeknikDosya #CEBelgelendirme #T\u0131bbiCihaz #ISO13485 #Kalitekit<\/p>","protected":false},"excerpt":{"rendered":"<p>MDR 2017\/745 kapsam\u0131nda CE belgesi i\u00e7in teknik dosya nas\u0131l haz\u0131rlan\u0131r? Annex II &#038; III&#8217;e g\u00f6re yap\u0131, i\u00e7erik ve resmi gereklilikler.<\/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":[305,306,310,162,308,309,307],"class_list":["post-9439","post","type-post","status-publish","format-standard","hentry","category-blog","tag-cebelgelendirme","tag-kalitekit","tag-kaliteyonetimi","tag-mdr","tag-technicaldocumentation","tag-teknikdosya","tag-tibbicihaz"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/9439","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=9439"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/9439\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=9439"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=9439"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=9439"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}