{"id":9521,"date":"2025-10-11T15:08:31","date_gmt":"2025-10-11T15:08:31","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=9521"},"modified":"2025-10-11T15:08:37","modified_gmt":"2025-10-11T15:08:37","slug":"mdr-ivdr-uyum-rehberi-tibbi-cihaz-ve-in-vitro-tani-cihazlari-icin-adim-adim-klinik-teknik-ve-risk-yonetimi-kilavuzu","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/mdr-ivdr-uyum-rehberi-tibbi-cihaz-ve-in-vitro-tani-cihazlari-icin-adim-adim-klinik-teknik-ve-risk-yonetimi-kilavuzu\/","title":{"rendered":"MDR &amp; IVDR Uyum Rehberi: T\u0131bbi Cihaz ve In Vitro Tan\u0131 Cihazlar\u0131 \u0130\u00e7in Ad\u0131m Ad\u0131m Klinik, Teknik ve Risk Y\u00f6netimi K\u0131lavuzu"},"content":{"rendered":"<h2 class=\"wp-block-heading\"><strong>B\u00f6l\u00fcm 1: MDR ve IVDR\u2019e Genel Bak\u0131\u015f, Yasal \u00c7er\u00e7eve ve Risk S\u0131n\u0131fland\u0131rmas\u0131<\/strong><\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">1.1 Giri\u015f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR (Medical Device Regulation, EU 2017\/745) ve IVDR (In Vitro Diagnostic Regulation, EU 2017\/746) Avrupa Birli\u011fi\u2019nin t\u0131bbi cihaz ve in vitro tan\u0131 cihazlar\u0131 i\u00e7in getirdi\u011fi <strong>en g\u00fcncel ve kapsaml\u0131 y\u00f6netmeliklerdir<\/strong>. Bu y\u00f6netmelikler, cihazlar\u0131n <strong>g\u00fcvenli, etkin ve reg\u00fclasyon uyumlu<\/strong> olmas\u0131n\u0131 sa\u011flamak amac\u0131yla geli\u015ftirilmi\u015ftir. MDR ve IVDR, hem \u00fcreticilere hem de yetkili temsilcilere ve distrib\u00fct\u00f6rlere \u00e7e\u015fitli sorumluluklar y\u00fckler.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Temel Ama\u00e7lar:<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Hasta ve kullan\u0131c\u0131 g\u00fcvenli\u011fini sa\u011flamak<\/strong><\/li>\n\n\n\n<li><strong>Cihazlar\u0131n etkinli\u011fini ve klinik performans\u0131n\u0131 garanti etmek<\/strong><\/li>\n\n\n\n<li><strong>Klinik de\u011ferlendirme ve risk y\u00f6netimini zorunlu k\u0131lmak<\/strong><\/li>\n\n\n\n<li><strong>Post-Market Surveillance (PMS) ve Post-Market Clinical Follow-Up (PMCF) s\u00fcre\u00e7lerini d\u00fczenlemek<\/strong><\/li>\n<\/ol>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">Not: MDR sadece t\u0131bbi cihazlar i\u00e7in ge\u00e7erken, IVDR in vitro tan\u0131 cihazlar\u0131n\u0131 kapsar. Ancak her iki y\u00f6netmelik de ISO 13485 ve ISO 14971 standard\u0131na uyumu destekler.<\/p>\n<\/blockquote>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">1.2 Yasal \u00c7er\u00e7eve ve MDCG Rehberleri<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR ve IVDR, <strong>resm\u00ee gazetede yay\u0131mlanan AB y\u00f6netmelikleri<\/strong>dir ve a\u015fa\u011f\u0131daki <strong>MDCG (Medical Device Coordination Group) rehberleri<\/strong> ile detayland\u0131r\u0131lm\u0131\u015ft\u0131r:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Y\u00f6netmelik<\/th><th>MDCG Rehberi<\/th><th>Konu<\/th><\/tr><\/thead><tbody><tr><td>MDR 2017\/745<\/td><td>MDCG 2021-3<\/td><td>S\u0131n\u0131fland\u0131rma ve uygunluk de\u011ferlendirmesi<\/td><\/tr><tr><td>MDR 2017\/745<\/td><td>MDCG 2020-5<\/td><td>Post-Market Surveillance (PMS)<\/td><\/tr><tr><td>IVDR 2017\/746<\/td><td>MDCG 2022-16<\/td><td>Klinik De\u011ferlendirme (CER) ve performans de\u011ferlendirmesi<\/td><\/tr><tr><td>IVDR 2017\/746<\/td><td>MDCG 2022-5<\/td><td>Post-Market Clinical Follow-Up (PMCF)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kaynaklar:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a>MDCG 2021-3<\/a><\/li>\n\n\n\n<li><a>MDCG 2020-5<\/a><\/li>\n\n\n\n<li><a>MDCG 2022-16<\/a><\/li>\n\n\n\n<li><a>MDR 2017\/745 \u2013 Official Journal<\/a><\/li>\n\n\n\n<li><a>IVDR 2017\/746 \u2013 Official Journal<\/a><\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">\u0130pucu: Her b\u00f6l\u00fcmde referans MDCG rehberi ve ilgili MDR\/IVDR maddesi belirtilmelidir. Bu, denetim ve uyum s\u00fcre\u00e7lerinde kritik \u00f6neme sahiptir.<\/p>\n<\/blockquote>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">1.3 T\u0131bbi Cihaz ve IVD S\u0131n\u0131fland\u0131rmas\u0131<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR ve IVDR, cihazlar\u0131 <strong>risk s\u0131n\u0131f\u0131na g\u00f6re s\u0131n\u0131fland\u0131r\u0131r<\/strong>. Bu s\u0131n\u0131fland\u0131rma, <strong>uygunluk de\u011ferlendirme prosed\u00fcr\u00fcn\u00fc ve klinik veri gerekliliklerini<\/strong> belirler.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1.3.1 MDR Cihaz S\u0131n\u0131flar\u0131<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>S\u0131n\u0131f<\/th><th>Risk Seviyesi<\/th><th>\u00d6rnek Cihazlar<\/th><\/tr><\/thead><tbody><tr><td>I<\/td><td>D\u00fc\u015f\u00fck<\/td><td>Bandaj, stetoskop<\/td><\/tr><tr><td>IIa<\/td><td>Orta<\/td><td>Ultrason cihaz\u0131, ins\u00fclin pompas\u0131<\/td><\/tr><tr><td>IIb<\/td><td>Y\u00fcksek<\/td><td>Ventilat\u00f6r, anjiyografi cihaz\u0131<\/td><\/tr><tr><td>III<\/td><td>\u00c7ok y\u00fcksek<\/td><td>Kalp kapa\u011f\u0131, kalp pili<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">1.3.2 IVDR Cihaz S\u0131n\u0131flar\u0131<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>S\u0131n\u0131f<\/th><th>Risk Seviyesi<\/th><th>\u00d6rnek Cihazlar<\/th><\/tr><\/thead><tbody><tr><td>A<\/td><td>D\u00fc\u015f\u00fck<\/td><td>Laboratuvar reaktifleri<\/td><\/tr><tr><td>B<\/td><td>Orta<\/td><td>Glikoz test kitleri<\/td><\/tr><tr><td>C<\/td><td>Y\u00fcksek<\/td><td>Kardiyomarker test kitleri<\/td><\/tr><tr><td>D<\/td><td>\u00c7ok y\u00fcksek<\/td><td>HIV, Hepatit, HPV test kitleri<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">Not: S\u0131n\u0131f artt\u0131k\u00e7a <strong>klinikal veri gereksinimi, denetim s\u0131k\u0131l\u0131\u011f\u0131 ve PMCF\/PMS y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc<\/strong> artar.<\/p>\n<\/blockquote>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">1.4 Risk Y\u00f6netimi Temelleri (ISO 14971)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14971 standard\u0131, <strong>t\u0131bbi cihaz ve IVD risk y\u00f6netimi i\u00e7in uluslararas\u0131 standartt\u0131r<\/strong>. Risk y\u00f6netimi s\u00fcreci MDR ve IVDR\u2019de zorunludur.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1.4.1 Ad\u0131m Ad\u0131m Risk Y\u00f6netimi<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Planlama:<\/strong> Risk y\u00f6netimi plan\u0131 olu\u015fturulur<\/li>\n\n\n\n<li><strong>Tehlike Tan\u0131mlama:<\/strong> Potansiyel riskler listelenir<\/li>\n\n\n\n<li><strong>Risk De\u011ferlendirmesi:<\/strong> Olas\u0131l\u0131k ve \u015fiddet de\u011ferlendirilir<\/li>\n\n\n\n<li><strong>Kontrol \u00d6nlemleri:<\/strong> Teknik, klinik veya s\u00fcre\u00e7 bazl\u0131 \u00f6nlemler belirlenir<\/li>\n\n\n\n<li><strong>Risk Kabul\u00fc:<\/strong> Y\u00f6netmelik ve klinik gereklilikler do\u011frultusunda karar verilir<\/li>\n\n\n\n<li><strong>Takip ve G\u00fcncelleme:<\/strong> PMS ve PMCF ile riskler d\u00fczenli takip edilir<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">1.4.2 \u00d6rnek Risk Matrisi<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Tehlike<\/th><th>Olas\u0131l\u0131k<\/th><th>\u015eiddet<\/th><th>Risk Seviyesi<\/th><th>Kontrol \u00d6nlemi<\/th><\/tr><\/thead><tbody><tr><td>Yanl\u0131\u015f pozitif test<\/td><td>Orta<\/td><td>Y\u00fcksek<\/td><td>Y\u00fcksek<\/td><td>Kalibrasyon, kontrol \u00f6rnekleri<\/td><\/tr><tr><td>Yanl\u0131\u015f negatif test<\/td><td>D\u00fc\u015f\u00fck<\/td><td>\u00c7ok Y\u00fcksek<\/td><td>Y\u00fcksek<\/td><td>\u0130kincil test, validasyon<\/td><\/tr><tr><td>Numune kontaminasyonu<\/td><td>Orta<\/td><td>Orta<\/td><td>Orta<\/td><td>Sterilizasyon, e\u011fitim<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">1.5 \u00d6zet<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDR &amp; IVDR <strong>hasta g\u00fcvenli\u011fi ve klinik performans<\/strong> odakl\u0131d\u0131r<\/li>\n\n\n\n<li>Cihaz s\u0131n\u0131fland\u0131rmas\u0131 ve risk analizi <strong>uyum s\u00fcrecinin temel ta\u015f\u0131d\u0131r<\/strong><\/li>\n\n\n\n<li>MDCG rehberleri ve ISO standartlar\u0131 <strong>uyum ve denetim rehberidir<\/strong><\/li>\n\n\n\n<li>Klinik ve teknik s\u00fcre\u00e7ler, <strong>denetime haz\u0131r, referansl\u0131 ve belgelenmi\u015f<\/strong> olmal\u0131d\u0131r<\/li>\n<\/ul>\n\n\n\n<h1 class=\"wp-block-heading\"><strong>B\u00f6l\u00fcm 2: Klinik De\u011ferlendirme ve CER Haz\u0131rlama \u2013 MDR &amp; IVDR\u2019de Ad\u0131m Ad\u0131m Rehber<\/strong><\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">2.1 Giri\u015f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Klinik De\u011ferlendirme Raporu (CER \u2013 Clinical Evaluation Report), MDR ve IVDR uyum s\u00fcrecinin <strong>en kritik belgelerinden biridir<\/strong>. Bu rapor, cihaz\u0131n <strong>g\u00fcvenli, etkin ve amac\u0131na uygun<\/strong> oldu\u011funu klinik verilerle kan\u0131tlar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IVDR\u2019de y\u00fcksek riskli (Class D) cihazlar i\u00e7in, <strong>Post-Market Clinical Follow-Up (PMCF)<\/strong> plan\u0131 da CER\u2019in ayr\u0131lmaz bir par\u00e7as\u0131d\u0131r. MDCG 2022-16 ve MDCG 2020-5 raporlar\u0131, <strong>CER ve PMCF haz\u0131rl\u0131\u011f\u0131 i\u00e7in detayl\u0131 rehberlik sa\u011flar<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kaynaklar:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a>MDCG 2022-16 \u2013 Clinical Evaluation for IVD<\/a><\/li>\n\n\n\n<li><a>MDCG 2020-5 \u2013 PMS &amp; PMCF<\/a><\/li>\n\n\n\n<li>IVDR 2017\/746, Annex XIII \u2013 Clinical Evidence<\/li>\n\n\n\n<li>MDR 2017\/745, Annex XIV \u2013 Clinical Evaluation<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">2.2 Klinik De\u011ferlendirme Ad\u0131mlar\u0131<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Klinik de\u011ferlendirme s\u00fcreci, <strong>toplama, analiz ve yorumlama<\/strong> a\u015famalar\u0131n\u0131 i\u00e7erir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2.2.1 Ad\u0131m 1: Cihaz Tan\u0131m\u0131 ve Kullan\u0131m Amac\u0131<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00dcr\u00fcn\u00fcn teknik \u00f6zellikleri ve kullan\u0131m amac\u0131 detayl\u0131 olarak tan\u0131mlan\u0131r.<\/li>\n\n\n\n<li>Hedef kullan\u0131c\u0131 ve hasta pop\u00fclasyonu belirlenir.<\/li>\n\n\n\n<li>Kullan\u0131m ko\u015fullar\u0131 ve klinik senaryolar a\u00e7\u0131klan\u0131r.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u00dcr\u00fcn<\/th><th>Kullan\u0131m Amac\u0131<\/th><th>Hedef Pop\u00fclasyon<\/th><\/tr><\/thead><tbody><tr><td>COVID-19 PCR Kit<\/td><td>SARS-CoV-2 RNA tespiti<\/td><td>Semptomatik ve asemptomatik yeti\u015fkin ve \u00e7ocuklar<\/td><\/tr><tr><td>Glikoz Test Strip<\/td><td>Kan \u015fekeri \u00f6l\u00e7\u00fcm\u00fc<\/td><td>Diyabet hastalar\u0131<\/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\">2.2.2 Ad\u0131m 2: Klinik Veri Toplama<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Klinik veriler <strong>prospektif \u00e7al\u0131\u015fmalardan, retrospektif analizlerden ve literat\u00fcr taramalar\u0131ndan<\/strong> elde edilir.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Veri Kaynaklar\u0131:<\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Prospektif klinik \u00e7al\u0131\u015fmalar:<\/strong> Yeni cihaz\u0131n ger\u00e7ek kullan\u0131m ko\u015fullar\u0131nda test edilmesi.<\/li>\n\n\n\n<li><strong>Retrospektif \u00e7al\u0131\u015fmalar:<\/strong> Daha \u00f6nceki verilerin analizi.<\/li>\n\n\n\n<li><strong>Literat\u00fcr verileri:<\/strong> Benzer cihazlardan veya sistematik incelemelerden elde edilen kan\u0131tlar.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Tablo: Klinik Veri Toplama<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Cihaz<\/th><th>\u00c7al\u0131\u015fma T\u00fcr\u00fc<\/th><th>Numune Say\u0131s\u0131<\/th><th>Sensitivite<\/th><th>Spesifite<\/th><\/tr><\/thead><tbody><tr><td>HIV Test Kiti<\/td><td>Prospektif<\/td><td>500<\/td><td>99%<\/td><td>98%<\/td><\/tr><tr><td>COVID-19 PCR<\/td><td>Retrospektif<\/td><td>1200<\/td><td>95%<\/td><td>99%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">\u0130pucu: Veriler, cihaz\u0131n s\u0131n\u0131f\u0131na g\u00f6re <strong>minimum veri gereksinimlerini<\/strong> kar\u015f\u0131lamal\u0131d\u0131r. Class D cihazlarda PMCF plan\u0131 \u015fartt\u0131r.<\/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\">2.2.3 Ad\u0131m 3: Klinik Veri Analizi ve De\u011ferlendirme<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Performans Analizi:<\/strong> Sensitivite, spesifite, do\u011fruluk, tekrarlanabilirlik \u00f6l\u00e7\u00fcl\u00fcr.<\/li>\n\n\n\n<li><strong>Risk Analizi:<\/strong> Yanl\u0131\u015f pozitif\/negatif sonu\u00e7lar\u0131n etkisi de\u011ferlendirilir.<\/li>\n\n\n\n<li><strong>Literat\u00fcr Kar\u015f\u0131la\u015ft\u0131rmas\u0131:<\/strong> Cihaz\u0131n benzer \u00fcr\u00fcnlerle performans\u0131 kar\u015f\u0131la\u015ft\u0131r\u0131l\u0131r.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Risk-Performans Tablosu:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Tehlike<\/th><th>Olas\u0131l\u0131k<\/th><th>\u015eiddet<\/th><th>Risk Seviyesi<\/th><th>Kontrol \u00d6nlemi<\/th><\/tr><\/thead><tbody><tr><td>Yanl\u0131\u015f pozitif<\/td><td>Orta<\/td><td>Y\u00fcksek<\/td><td>Y\u00fcksek<\/td><td>Tekrar test, kontrol \u00f6rnekleri<\/td><\/tr><tr><td>Yanl\u0131\u015f negatif<\/td><td>D\u00fc\u015f\u00fck<\/td><td>\u00c7ok Y\u00fcksek<\/td><td>Y\u00fcksek<\/td><td>\u0130kincil do\u011frulama testi<\/td><\/tr><tr><td>Numune kontaminasyonu<\/td><td>Orta<\/td><td>Orta<\/td><td>Orta<\/td><td>Sterilizasyon, e\u011fitim<\/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\">2.2.4 Ad\u0131m 4: CER Raporu Yap\u0131s\u0131<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">CER raporu, <strong>toplanan verilerin analiz edildi\u011fi ve sonu\u00e7lar\u0131n yorumland\u0131\u011f\u0131 belgeler b\u00fct\u00fcn\u00fcd\u00fcr<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>B\u00f6l\u00fcm Ba\u015fl\u0131klar\u0131 \u00d6rne\u011fi:<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Giri\u015f ve cihaz tan\u0131m\u0131<\/li>\n\n\n\n<li>Kullan\u0131m amac\u0131 ve hasta pop\u00fclasyonu<\/li>\n\n\n\n<li>Klinik veri toplama metodolojisi<\/li>\n\n\n\n<li>Performans analizi (tablo ve grafikler)<\/li>\n\n\n\n<li>Risk de\u011ferlendirmesi<\/li>\n\n\n\n<li>Karar ve sonu\u00e7lar<\/li>\n\n\n\n<li>PMCF plan\u0131 (Class C\/D cihazlar i\u00e7in)<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Grafik \u00d6rne\u011fi:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sensitivite ve spesifite trend grafi\u011fi, cihaz\u0131n farkl\u0131 hasta pop\u00fclasyonlar\u0131nda performans\u0131n\u0131 g\u00f6sterir.<\/li>\n\n\n\n<li>Advers olay say\u0131s\u0131 ve tiplerine g\u00f6re da\u011f\u0131l\u0131m grafi\u011fi, PMS s\u00fcreci ile ili\u015fkilendirilir.<\/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\">2.2.5 Ad\u0131m 5: Post-Market Clinical Follow-Up (PMCF)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>PMCF, cihaz piyasaya sunulduktan sonra <strong>klinik verilerin s\u00fcrekli toplanmas\u0131 ve g\u00fcncellenmesi<\/strong> s\u00fcrecidir.<\/li>\n\n\n\n<li>MDCG 2020-5 ve IVDR Annex XIII uyar\u0131nca Class D cihazlarda zorunludur.<\/li>\n\n\n\n<li><strong>PMCF Plan\u0131 \u0130\u00e7eri\u011fi:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Veri toplama y\u00f6ntemi<\/li>\n\n\n\n<li>S\u0131kl\u0131k ve zaman \u00e7izelgesi<\/li>\n\n\n\n<li>Performans trend analizi<\/li>\n\n\n\n<li>Advers olay ve risk izleme<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek PMCF Tablosu:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Zaman<\/th><th>Veri Tipi<\/th><th>Numune Say\u0131s\u0131<\/th><th>Risk Analizi<\/th><th>Notlar<\/th><\/tr><\/thead><tbody><tr><td>6 ay<\/td><td>Sensitivite testi<\/td><td>200<\/td><td>Orta<\/td><td>\u0130yile\u015ftirme \u00f6nerisi<\/td><\/tr><tr><td>12 ay<\/td><td>Advers olay raporu<\/td><td>500<\/td><td>Y\u00fcksek<\/td><td>E\u011fitim g\u00fcncellemesi<\/td><\/tr><tr><td>24 ay<\/td><td>Literat\u00fcr taramas\u0131<\/td><td>&#8211;<\/td><td>D\u00fc\u015f\u00fck<\/td><td>Yeni bilimsel veri<\/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\">2.3 \u00d6rnek Vaka \u00c7al\u0131\u015fmas\u0131: COVID-19 PCR Kitleri<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Cihaz Tan\u0131m\u0131:<\/strong> SARS-CoV-2 RNA tespiti<\/li>\n\n\n\n<li><strong>Klinik Veri Toplama:<\/strong> 1200 hasta, 3 laboratuvar<\/li>\n\n\n\n<li><strong>Analiz:<\/strong> Sensitivite 95%, spesifite 99%<\/li>\n\n\n\n<li><strong>Risk Y\u00f6netimi:<\/strong> Yanl\u0131\u015f negatifler i\u00e7in ikincil do\u011frulama testi \u00f6nerildi<\/li>\n\n\n\n<li><strong>PMCF Plan\u0131:<\/strong> 6 ayda veri g\u00fcncelleme, advers olay bildirimi<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">2.4 \u00d6zet<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Klinik de\u011ferlendirme, <strong>MDR\/IVDR uyum s\u00fcrecinin kalbidir<\/strong><\/li>\n\n\n\n<li>CER raporu, <strong>toplanan verilerin analizi ve yorumlanmas\u0131 ile tamamlan\u0131r<\/strong><\/li>\n\n\n\n<li>Class C\/D cihazlarda PMCF plan\u0131 <strong>zorunlu ve denetime haz\u0131r olmal\u0131d\u0131r<\/strong><\/li>\n\n\n\n<li>Tablo, grafik ve literat\u00fcr referanslar\u0131 kullanmak, <strong>raporun denetim ba\u015far\u0131s\u0131n\u0131 art\u0131r\u0131r<\/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\">2.5 Kaynaklar<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDCG 2022-16: <a>Clinical Evaluation Guidance for IVD Devices<\/a><\/li>\n\n\n\n<li>MDCG 2020-5: <a>Post-Market Surveillance Guidance<\/a><\/li>\n\n\n\n<li>IVDR 2017\/746 \u2013 Annex XIII<\/li>\n\n\n\n<li>MDR 2017\/745 \u2013 Annex XIV<\/li>\n\n\n\n<li>ISO 13485:2016 \u2013 T\u0131bbi Cihaz Kalite Y\u00f6netim Sistemi<\/li>\n\n\n\n<li>ISO 14971:2019 \u2013 Risk Management for Medical Devices<\/li>\n<\/ul>\n\n\n\n<h1 class=\"wp-block-heading\"><strong>B\u00f6l\u00fcm 3: Risk Y\u00f6netimi, Advers Olay ve PMS S\u00fcre\u00e7leri \u2013 MDR &amp; IVDR\u2019de Detayl\u0131 Rehber<\/strong><\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">3.1 Giri\u015f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR ve IVDR uyum s\u00fcrecinde <strong>risk y\u00f6netimi ve post-market surveillance (PMS)<\/strong>, cihaz g\u00fcvenli\u011finin ve klinik performans\u0131n s\u00fcrekli sa\u011flanmas\u0131 i\u00e7in temel ta\u015flard\u0131r. Bu b\u00f6l\u00fcmde:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Risk y\u00f6netimi s\u00fcre\u00e7leri (ISO 14971)<\/li>\n\n\n\n<li>Advers olaylar\u0131n tan\u0131mlanmas\u0131 ve s\u0131n\u0131fland\u0131r\u0131lmas\u0131<\/li>\n\n\n\n<li>PMS ve PMCF uygulamalar\u0131<\/li>\n\n\n\n<li>\u00d6rnek tablolar, grafikler ve vaka \u00e7al\u0131\u015fmalar\u0131<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">detayl\u0131 olarak incelenecektir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kaynaklar:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 14971:2019 \u2013 Risk Management for Medical Devices<\/li>\n\n\n\n<li>MDCG 2020-5 \u2013 PMS &amp; PMCF Guidance<\/li>\n\n\n\n<li>MDR 2017\/745, Annex XIV ve Annex III<\/li>\n\n\n\n<li>IVDR 2017\/746, Annex XIII<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">3.2 Risk Y\u00f6netimi Temel Ad\u0131mlar\u0131<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14971\u2019e g\u00f6re risk y\u00f6netimi s\u00fcreci, <strong>planlama, tan\u0131mlama, analiz, de\u011ferlendirme, kontrol ve takip<\/strong> ad\u0131mlar\u0131n\u0131 i\u00e7erir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3.2.1 Ad\u0131m 1: Risk Y\u00f6netim Plan\u0131 Olu\u015fturma<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ama\u00e7:<\/strong> Cihaz\u0131n kullan\u0131m\u0131nda ortaya \u00e7\u0131kabilecek t\u00fcm riskleri tan\u0131mlamak ve kontrol \u00f6nlemleri belirlemek.<\/li>\n\n\n\n<li><strong>\u0130\u00e7erik:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Cihaz s\u0131n\u0131f\u0131 ve kullan\u0131m amac\u0131<\/li>\n\n\n\n<li>Risk y\u00f6netimi sorumlular\u0131<\/li>\n\n\n\n<li>PMS ve PMCF entegrasyonu<\/li>\n\n\n\n<li>Dok\u00fcmantasyon ve raporlama prosed\u00fcr\u00fc<\/li>\n<\/ul>\n<\/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\">3.2.2 Ad\u0131m 2: Tehlikelerin Tan\u0131mlanmas\u0131<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>T\u00fcm potansiyel tehlikeler belirlenir:\n<ul class=\"wp-block-list\">\n<li>Kullan\u0131c\u0131 hatalar\u0131<\/li>\n\n\n\n<li>Cihaz ar\u0131zalar\u0131<\/li>\n\n\n\n<li>Kimyasal, biyolojik veya fiziksel riskler<\/li>\n\n\n\n<li>Yaz\u0131l\u0131m hatalar\u0131<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Tablo: Tehlike Listesi<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Tehlike<\/th><th>Kaynak<\/th><th>Potansiyel Etki<\/th><\/tr><\/thead><tbody><tr><td>Yanl\u0131\u015f pozitif test<\/td><td>Analiz cihaz\u0131<\/td><td>Yanl\u0131\u015f tedavi<\/td><\/tr><tr><td>Yanl\u0131\u015f negatif test<\/td><td>Numune hatas\u0131<\/td><td>Hastal\u0131k yay\u0131l\u0131m\u0131<\/td><\/tr><tr><td>Kontaminasyon<\/td><td>\u00dcretim s\u00fcreci<\/td><td>Enfeksiyon riski<\/td><\/tr><tr><td>Yaz\u0131l\u0131m ar\u0131zas\u0131<\/td><td>Cihaz yaz\u0131l\u0131m\u0131<\/td><td>Test sonu\u00e7lar\u0131n\u0131n hatal\u0131 raporlanmas\u0131<\/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\">3.2.3 Ad\u0131m 3: Risk Analizi<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Olas\u0131l\u0131k ve \u015fiddet de\u011ferlendirmesi<\/strong> ile risk seviyesi belirlenir.<\/li>\n\n\n\n<li><strong>Risk matrisi<\/strong> kullan\u0131larak \u00f6nceliklendirme yap\u0131l\u0131r.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Risk Matrisi:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Olas\u0131l\u0131k<\/th><th>\u00c7ok D\u00fc\u015f\u00fck<\/th><th>D\u00fc\u015f\u00fck<\/th><th>Orta<\/th><th>Y\u00fcksek<\/th><th>\u00c7ok Y\u00fcksek<\/th><\/tr><\/thead><tbody><tr><td>\u00c7ok \u015eiddetli<\/td><td>H<\/td><td>H<\/td><td>E<\/td><td>E<\/td><td>E<\/td><\/tr><tr><td>Y\u00fcksek<\/td><td>H<\/td><td>E<\/td><td>E<\/td><td>M<\/td><td>M<\/td><\/tr><tr><td>Orta<\/td><td>E<\/td><td>E<\/td><td>M<\/td><td>M<\/td><td>L<\/td><\/tr><tr><td>D\u00fc\u015f\u00fck<\/td><td>E<\/td><td>M<\/td><td>M<\/td><td>L<\/td><td>L<\/td><\/tr><tr><td>\u00c7ok D\u00fc\u015f\u00fck<\/td><td>M<\/td><td>M<\/td><td>L<\/td><td>L<\/td><td>L<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">H: High (y\u00fcksek), M: Medium (orta), L: Low (d\u00fc\u015f\u00fck), E: Extreme (\u00e7ok y\u00fcksek)<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">3.2.4 Ad\u0131m 4: Risk Kontrol \u00d6nlemleri<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Teknik \u00f6nlemler:<\/strong> Tasar\u0131m de\u011fi\u015fikli\u011fi, g\u00fcvenlik \u00f6zellikleri<\/li>\n\n\n\n<li><strong>Klinik \u00f6nlemler:<\/strong> Kullan\u0131c\u0131 e\u011fitimi, kullan\u0131m k\u0131lavuzu<\/li>\n\n\n\n<li><strong>\u00dcretim \u00f6nlemleri:<\/strong> Sterilizasyon, kalite kontrol<\/li>\n\n\n\n<li><strong>Yaz\u0131l\u0131m \u00f6nlemleri:<\/strong> Hata y\u00f6netimi, validasyon<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Risk<\/th><th>Kontrol \u00d6nlemi<\/th><th>Sorumlu<\/th><\/tr><\/thead><tbody><tr><td>Yanl\u0131\u015f negatif<\/td><td>\u0130kincil do\u011frulama testi<\/td><td>\u00dcretici<\/td><\/tr><tr><td>Kontaminasyon<\/td><td>Sterilizasyon prosed\u00fcr\u00fc<\/td><td>\u00dcretim<\/td><\/tr><tr><td>Yaz\u0131l\u0131m hatas\u0131<\/td><td>G\u00fcnl\u00fck yaz\u0131l\u0131m do\u011frulama<\/td><td>AR-GE<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">3.3 Advers Olay Y\u00f6netimi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Advers olay (AE), cihaz kullan\u0131m\u0131 s\u0131ras\u0131nda ortaya \u00e7\u0131kan <strong>istenmeyen veya zararl\u0131 bir durumu<\/strong> ifade eder. MDR ve IVDR\u2019de zorunlu olarak <strong>bildirim yap\u0131lmas\u0131 gereken olaylar<\/strong> tan\u0131mlanm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3.3.1 AE S\u0131n\u0131fland\u0131rmas\u0131<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>S\u0131n\u0131f<\/th><th>\u00d6rnek Olay<\/th><th>Bildirim S\u00fcresi<\/th><\/tr><\/thead><tbody><tr><td>Ciddi<\/td><td>Hasta \u00f6l\u00fcm\u00fc veya kal\u0131c\u0131 hasar<\/td><td>10 g\u00fcn (MDR)<\/td><\/tr><tr><td>Orta<\/td><td>Ge\u00e7ici zarar veya tedavi gerektiren olay<\/td><td>30 g\u00fcn<\/td><\/tr><tr><td>Hafif<\/td><td>K\u00fc\u00e7\u00fck rahats\u0131zl\u0131k, tedavi gerektirmeyen<\/td><td>Y\u0131ll\u0131k rapor<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">3.3.2 AE Raporlama<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Kullan\u0131c\u0131 bildirimi:<\/strong> Klinik ortamdan gelen raporlar<\/li>\n\n\n\n<li><strong>\u00dcretici bildirimi:<\/strong> PMS ve PMCF verileri \u00fczerinden tespit<\/li>\n\n\n\n<li><strong>Yetkili makam bildirimi:<\/strong> EUDAMED \u00fczerinden raporlama<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Advers Olay Tablosu:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Tarih<\/th><th>Olay T\u00fcr\u00fc<\/th><th>\u015eiddet<\/th><th>Cihaz<\/th><th>\u00d6nlem<\/th><\/tr><\/thead><tbody><tr><td>01\/08\/2025<\/td><td>Yanl\u0131\u015f negatif<\/td><td>Y\u00fcksek<\/td><td>Glikoz Test<\/td><td>Kullan\u0131c\u0131 e\u011fitimi<\/td><\/tr><tr><td>15\/09\/2025<\/td><td>Kontaminasyon<\/td><td>Orta<\/td><td>PCR Kit<\/td><td>Sterilizasyon g\u00fcncellemesi<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">3.4 Post-Market Surveillance (PMS) S\u00fcreci<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PMS, <strong>cihaz\u0131n piyasaya sunulduktan sonra g\u00fcvenlik ve performans\u0131n\u0131n izlenmesi<\/strong> s\u00fcrecidir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3.4.1 PMS Ad\u0131mlar\u0131<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Pazar verisi toplama:<\/strong> Sat\u0131\u015f sonras\u0131 kullan\u0131c\u0131 geri bildirimleri<\/li>\n\n\n\n<li><strong>Advers olay analizi:<\/strong> AE kay\u0131tlar\u0131, trend analizi<\/li>\n\n\n\n<li><strong>Risk g\u00fcncelleme:<\/strong> ISO 14971 risk matrisi g\u00fcncellenir<\/li>\n\n\n\n<li><strong>D\u00fczeltici \/ \u00d6nleyici Faaliyetler (CAPA):<\/strong> Hatalar\u0131n d\u00fczeltilmesi<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">3.4.2 PMS Plan\u0131 \u00d6rne\u011fi<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Aktivite<\/th><th>S\u0131kl\u0131k<\/th><th>Sorumlu<\/th><th>Notlar<\/th><\/tr><\/thead><tbody><tr><td>AE rapor analizi<\/td><td>Ayl\u0131k<\/td><td>QA<\/td><td>Trend grafi\u011fi ile analiz<\/td><\/tr><tr><td>Kullan\u0131c\u0131 anketleri<\/td><td>6 ay<\/td><td>Klinik<\/td><td>Memnuniyet ve g\u00fcvenlik<\/td><\/tr><tr><td>Literat\u00fcr g\u00fcncellemesi<\/td><td>Y\u0131ll\u0131k<\/td><td>RA<\/td><td>Yeni kan\u0131tlar i\u00e7in tarama<\/td><\/tr><tr><td>Risk matrisi g\u00fcncelleme<\/td><td>12 ay<\/td><td>QA\/RA<\/td><td>Yeni olaylara g\u00f6re d\u00fczeltme<\/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\">3.5 Vaka \u00c7al\u0131\u015fmas\u0131: Glikoz Test Cihaz\u0131<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Risk Y\u00f6netimi:<\/strong> Yanl\u0131\u015f negatif sonucu i\u00e7in ikincil do\u011frulama testi uygulan\u0131r<\/li>\n\n\n\n<li><strong>Advers Olay:<\/strong> 3 vaka kullan\u0131c\u0131dan raporland\u0131, 1 ciddi<\/li>\n\n\n\n<li><strong>PMS:<\/strong> Trend analizi ile cihaz performans\u0131 s\u00fcrekli izleniyor<\/li>\n\n\n\n<li><strong>CAPA:<\/strong> Kullan\u0131c\u0131 e\u011fitim materyali g\u00fcncellendi, cihaz yaz\u0131l\u0131m\u0131 revize edildi<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Grafik \u00d6rne\u011fi:<\/strong> AE trend grafi\u011fi, cihaz performans\u0131n\u0131n PMS ile nas\u0131l izlendi\u011fini g\u00f6sterir.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">3.6 \u00d6zet<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Risk y\u00f6netimi<\/strong>, cihaz g\u00fcvenli\u011fi ve klinik performans\u0131n temeli<\/li>\n\n\n\n<li><strong>Advers olay raporlamas\u0131<\/strong> MDR &amp; IVDR\u2019de zorunlu<\/li>\n\n\n\n<li><strong>PMS ve PMCF<\/strong>, verilerin s\u00fcrekli g\u00fcncellenmesi ve risk kontrol\u00fcn\u00fcn sa\u011flanmas\u0131 i\u00e7in kritik<\/li>\n\n\n\n<li>Tablolar ve grafiklerle <strong>veri odakl\u0131 karar alma<\/strong>, denetim ve uyum s\u00fcre\u00e7lerinde ba\u015far\u0131y\u0131 art\u0131r\u0131r<\/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\">3.7 Kaynaklar<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 14971:2019 \u2013 Risk Management for Medical Devices<\/li>\n\n\n\n<li>MDCG 2020-5 \u2013 Post-Market Surveillance &amp; PMCF Guidance<\/li>\n\n\n\n<li>MDR 2017\/745 \u2013 Annex III, XIV<\/li>\n\n\n\n<li>IVDR 2017\/746 \u2013 Annex XIII<\/li>\n\n\n\n<li>EUDAMED Database \u2013 EU Medical Device Reporting<\/li>\n<\/ul>\n\n\n\n<h1 class=\"wp-block-heading\"><strong>B\u00f6l\u00fcm 4: Teknik Dosya (Technical Documentation) Haz\u0131rlama Rehberi \u2013 MDR &amp; IVDR<\/strong><\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">4.1 Giri\u015f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR 2017\/745 ve IVDR 2017\/746 kapsam\u0131nda, t\u0131bbi cihaz ve in vitro tan\u0131 cihazlar\u0131n\u0131n <strong>piyasaya sunulmadan \u00f6nce ve sonras\u0131nda g\u00fcvenli ve etkili oldu\u011funu kan\u0131tlamak<\/strong> i\u00e7in kapsaml\u0131 bir teknik dosya haz\u0131rlanmas\u0131 zorunludur. Teknik dosya, cihaz\u0131n tasar\u0131m\u0131ndan \u00fcretimine, risk y\u00f6netiminden klinik performans\u0131na kadar t\u00fcm bilgileri i\u00e7eren <strong>denetime haz\u0131r, do\u011frulanabilir bir belgedir<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Teknik dosya haz\u0131rlan\u0131rken a\u015fa\u011f\u0131daki temel ilkeler g\u00f6z \u00f6n\u00fcnde bulundurulmal\u0131d\u0131r:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Taml\u0131k ve do\u011fruluk:<\/strong> T\u00fcm cihaz \u00f6zellikleri, test sonu\u00e7lar\u0131, risk de\u011ferlendirmeleri ve klinik veriler eksiksiz olmal\u0131d\u0131r.<\/li>\n\n\n\n<li><strong>Denetime haz\u0131r olma:<\/strong> Dosya, yetkili makamlar ve onaylanm\u0131\u015f kurulu\u015flar taraf\u0131ndan denetlenmeye haz\u0131r olmal\u0131d\u0131r.<\/li>\n\n\n\n<li><strong>Uyumluluk referanslar\u0131:<\/strong> MDR\/IVDR maddelerine ve MDCG rehberlerine uygun olarak haz\u0131rlanmal\u0131d\u0131r.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kaynaklar:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDR 2017\/745, Annex II &amp; III<\/li>\n\n\n\n<li>IVDR 2017\/746, Annex II &amp; III<\/li>\n\n\n\n<li>MDCG 2021-3 \u2013 Technical Documentation Guidance<\/li>\n\n\n\n<li>ISO 13485:2016 \u2013 Medical Device Quality Management Systems<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">4.2 Teknik Dosya B\u00f6l\u00fcmleri ve Detayl\u0131 A\u00e7\u0131klamalar\u0131<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">4.2.1 Cihaz Tan\u0131m\u0131 ve Ama\u00e7lanan Kullan\u0131m<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Teknik dosya, cihaz\u0131n <strong>ad\u0131n\u0131, modelini, yaz\u0131l\u0131m versiyonunu ve kullan\u0131m amac\u0131n\u0131<\/strong> a\u00e7\u0131k\u00e7a belirtmekle ba\u015flar. Bu b\u00f6l\u00fcm, cihaz\u0131n hangi <strong>hasta grubuna<\/strong> hitap etti\u011fini, hangi ko\u015fullarda kullan\u0131laca\u011f\u0131n\u0131, hangi endikasyonlar ve kontrendikasyonlar\u0131n ge\u00e7erli oldu\u011funu net olarak tan\u0131mlar.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ama\u00e7lanan kullan\u0131m:<\/strong> Cihaz\u0131n ne i\u00e7in tasarland\u0131\u011f\u0131n\u0131 ve hangi klinik sorunu \u00e7\u00f6zd\u00fc\u011f\u00fcn\u00fc a\u00e7\u0131klar.<\/li>\n\n\n\n<li><strong>Hedef pop\u00fclasyon:<\/strong> \u00d6rn. yeti\u015fkin diyabet hastalar\u0131, pediatrik hastalar vb.<\/li>\n\n\n\n<li><strong>Kullan\u0131m ko\u015fullar\u0131:<\/strong> Ev, klinik, laboratuvar gibi ortamlar.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Tablo \u2013 Cihaz Tan\u0131m\u0131:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Alan<\/th><th>A\u00e7\u0131klama<\/th><\/tr><\/thead><tbody><tr><td>Cihaz Ad\u0131<\/td><td>Glikoz Test Strip<\/td><\/tr><tr><td>Model \/ Seri No<\/td><td>GT-2025<\/td><\/tr><tr><td>Ama\u00e7lanan Kullan\u0131m<\/td><td>Kan \u015fekeri \u00f6l\u00e7\u00fcm\u00fc<\/td><\/tr><tr><td>Hedef Pop\u00fclasyon<\/td><td>Diyabet hastalar\u0131<\/td><\/tr><tr><td>Kullan\u0131m Ko\u015fullar\u0131<\/td><td>Ev ve klinik ortam, parmak ucu kan \u00f6rne\u011fi<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Bu bilgiler, <strong>risk y\u00f6netimi ve klinik de\u011ferlendirme<\/strong> s\u00fcre\u00e7lerinin temelini olu\u015fturur. MDR Annex II, cihaz tan\u0131m\u0131n\u0131n eksiksiz olmas\u0131n\u0131 zorunlu k\u0131lar.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">4.2.2 Tasar\u0131m ve Teknik \u00d6zellikler<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Bu b\u00f6l\u00fcmde cihaz\u0131n <strong>mekanik, elektriksel ve yaz\u0131l\u0131msal tasar\u0131m\u0131<\/strong> detayl\u0131 \u015fekilde a\u00e7\u0131klan\u0131r. Teknik \u00f6zellikler, cihaz\u0131n g\u00fcvenli ve etkili \u00e7al\u0131\u015fmas\u0131n\u0131 destekleyen <strong>\u00f6l\u00e7\u00fcm aral\u0131\u011f\u0131, do\u011fruluk, \u00f6rnek hacmi, \u00e7al\u0131\u015fma ko\u015fullar\u0131<\/strong> gibi parametreleri i\u00e7erir.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>CAD \u00e7izimleri ve \u015femalar:<\/strong> Tasar\u0131m\u0131n g\u00f6rsel kan\u0131t\u0131.<\/li>\n\n\n\n<li><strong>Malzeme ve bile\u015fen listesi (BOM):<\/strong> Her bile\u015fenin \u00fcretici, teknik \u00f6zellik ve onay durumu.<\/li>\n\n\n\n<li><strong>Yaz\u0131l\u0131m versiyonu ve validasyon:<\/strong> Yaz\u0131l\u0131m\u0131n klinik do\u011frulu\u011fu ve hata y\u00f6netimi.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Tablo \u2013 Teknik \u00d6zellikler:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u00d6zellik<\/th><th>Parametre<\/th><th>Test Standard\u0131<\/th><\/tr><\/thead><tbody><tr><td>\u00d6l\u00e7\u00fcm Aral\u0131\u011f\u0131<\/td><td>20 \u2013 600 mg\/dL<\/td><td>ISO 15197:2013<\/td><\/tr><tr><td>Do\u011fruluk<\/td><td>\u00b15 mg\/dL<\/td><td>ISO 15197:2013<\/td><\/tr><tr><td>\u00d6rnek Hacmi<\/td><td>0.5 \u00b5L<\/td><td>ISO 15197:2013<\/td><\/tr><tr><td>\u00c7al\u0131\u015fma S\u0131cakl\u0131\u011f\u0131<\/td><td>10\u201340\u00b0C<\/td><td>IEC 60601-1<\/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\">4.2.3 Risk Y\u00f6netimi ve ISO 14971 Entegrasyonu<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Teknik dosya, <strong>risk y\u00f6netimi dosyas\u0131n\u0131<\/strong> i\u00e7ermelidir. Bu dosya, tehlikeleri tan\u0131mlar, riskleri analiz eder, kontrol \u00f6nlemlerini ve risklerin kabul edilebilirli\u011fini a\u00e7\u0131klar. PMS ve PMCF planlar\u0131 risk y\u00f6netimi ile entegre olmal\u0131d\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek: Risk Matrisi ve Kontrol \u00d6nlemleri<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Risk<\/th><th>Olas\u0131l\u0131k<\/th><th>\u015eiddet<\/th><th>Risk D\u00fczeyi<\/th><th>Kontrol \u00d6nlemi<\/th><\/tr><\/thead><tbody><tr><td>Yanl\u0131\u015f negatif<\/td><td>Orta<\/td><td>Y\u00fcksek<\/td><td>Y\u00fcksek<\/td><td>\u0130kincil do\u011frulama testi<\/td><\/tr><tr><td>Kontaminasyon<\/td><td>D\u00fc\u015f\u00fck<\/td><td>Y\u00fcksek<\/td><td>Orta<\/td><td>Sterilizasyon prosed\u00fcr\u00fc<\/td><\/tr><tr><td>Yaz\u0131l\u0131m hatas\u0131<\/td><td>D\u00fc\u015f\u00fck<\/td><td>Orta<\/td><td>Orta<\/td><td>G\u00fcnl\u00fck yaz\u0131l\u0131m do\u011frulama<\/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\">4.2.4 Klinik De\u011ferlendirme ve PMCF<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Cihaz\u0131n klinik performans\u0131n\u0131 kan\u0131tlamak i\u00e7in <strong>CER (Clinical Evaluation Report)<\/strong> ve <strong>PMCF (Post-Market Clinical Follow-Up)<\/strong> raporlar\u0131 teknik dosyada bulunur. Bu raporlar:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Literat\u00fcr taramas\u0131 ve klinik veri analizi ile desteklenir.<\/li>\n\n\n\n<li>Cihaz\u0131n piyasaya sunulmas\u0131ndan sonra <strong>risk ve performans takibini sa\u011flar<\/strong>.<\/li>\n\n\n\n<li>Advers olay ve PMS verileri ile g\u00fcncellenir.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Tablo \u2013 PMCF Plan\u0131<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Zaman \u00c7izelgesi<\/th><th>Veri T\u00fcr\u00fc<\/th><th>Numune Say\u0131s\u0131<\/th><th>Risk \u0130zleme<\/th><th>Notlar<\/th><\/tr><\/thead><tbody><tr><td>6 Ay<\/td><td>Sensitivite testi<\/td><td>200<\/td><td>Orta<\/td><td>Kullan\u0131c\u0131 e\u011fitimi revizesi<\/td><\/tr><tr><td>12 Ay<\/td><td>AE analizi<\/td><td>500<\/td><td>Y\u00fcksek<\/td><td>CAPA plan\u0131 uygulanacak<\/td><\/tr><tr><td>24 Ay<\/td><td>Literat\u00fcr taramas\u0131<\/td><td>&#8211;<\/td><td>D\u00fc\u015f\u00fck<\/td><td>Yeni bilimsel veri takibi<\/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\">4.2.5 \u00dcretim ve Malzeme Bilgisi<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Teknik dosyada, cihaz\u0131n \u00fcretim s\u00fcre\u00e7leri ve kullan\u0131lan malzemeler detayl\u0131 \u015fekilde belgelenmelidir. Hammadde onaylar\u0131, tedarik\u00e7i belgeleri, batch traceability ve \u00fcretim kontrol raporlar\u0131 burada yer al\u0131r. Her bile\u015fen, test ve validasyon bilgisi ile birlikte sunulmal\u0131d\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Tablo \u2013 Malzeme Bilgisi<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Malzeme \/ Bile\u015fen<\/th><th>Tedarik\u00e7i<\/th><th>Test Standard\u0131<\/th><th>Onay Durumu<\/th><\/tr><\/thead><tbody><tr><td>Test Strip Film<\/td><td>XYZ Medical<\/td><td>ISO 10993<\/td><td>Uygun<\/td><\/tr><tr><td>Reaktif<\/td><td>ABC Chemicals<\/td><td>USP \/ ISO 10993<\/td><td>Uygun<\/td><\/tr><tr><td>Plastik G\u00f6vde<\/td><td>DEF Plastics<\/td><td>ISO 10993<\/td><td>Uygun<\/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\">4.2.6 Etiketleme ve Kullan\u0131m K\u0131lavuzu<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CE i\u015fareti, UDI, \u00fcretim ve son kullanma tarihi etiket \u00fczerinde olmal\u0131d\u0131r.<\/li>\n\n\n\n<li>Kullan\u0131m k\u0131lavuzu, <strong>ad\u0131m ad\u0131m talimat, riskler, kontrendikasyonlar ve uyar\u0131lar<\/strong> i\u00e7ermelidir.<\/li>\n\n\n\n<li>MDR\/IVDR uyumlu olmal\u0131 ve klinik de\u011ferlendirme verilerini desteklemelidir.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Etiketleme Bilgisi:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00dcr\u00fcn Ad\u0131: Glikoz Test Strip<\/li>\n\n\n\n<li>Model: GT-2025<\/li>\n\n\n\n<li>CE \u0130\u015fareti: CE 0123<\/li>\n\n\n\n<li>UDI: 12345678901234<\/li>\n\n\n\n<li>\u00dcretim Tarihi: 01\/2025<\/li>\n\n\n\n<li>Son Kullanma Tarihi: 01\/2027<\/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\">4.2.7 Uyumluluk Beyan\u0131 ve Sertifikalar<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Teknik dosya, cihaz\u0131n <strong>MDR\/IVDR\u2019e uygun oldu\u011funu g\u00f6steren Declaration of Conformity (DoC)<\/strong> ve t\u00fcm test, sertifika ve raporlar\u0131 i\u00e7erir. Denetimlerde ve resmi ba\u015fvurularda haz\u0131r bulunmal\u0131d\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">4.3 \u00d6rnek Vaka \u00c7al\u0131\u015fmas\u0131: Glikoz Test Strip<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Teknik Dosya:<\/strong> Malzeme listesi, CAD \u00e7izimleri, ISO 15197 test raporlar\u0131.<\/li>\n\n\n\n<li><strong>Risk Y\u00f6netimi:<\/strong> Yanl\u0131\u015f negatif i\u00e7in ikincil test, kontaminasyon \u00f6nlemleri.<\/li>\n\n\n\n<li><strong>Klinik De\u011ferlendirme ve PMCF:<\/strong> 6, 12, 24 ay veri takibi, AE analizi.<\/li>\n\n\n\n<li><strong>Etiket ve K\u0131lavuz:<\/strong> CE i\u015fareti, UDI, kullan\u0131m talimatlar\u0131.<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">4.4 \u00d6zet<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Teknik dosya, MDR\/IVDR uyum s\u00fcrecinin <strong>temel belgesi<\/strong>dir.<\/li>\n\n\n\n<li>Her b\u00f6l\u00fcm <strong>detayl\u0131 ve denetime haz\u0131r<\/strong> olmal\u0131d\u0131r.<\/li>\n\n\n\n<li>Klinik veriler, risk y\u00f6netimi, \u00fcretim ve etiketleme bilgileri, <strong>cihaz\u0131n g\u00fcvenli ve etkili oldu\u011funu kan\u0131tlamak i\u00e7in<\/strong> eksiksiz olmal\u0131d\u0131r.<\/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\">4.5 Kaynaklar<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDR 2017\/745 \u2013 Annex II &amp; III<\/li>\n\n\n\n<li>IVDR 2017\/746 \u2013 Annex II &amp; III<\/li>\n\n\n\n<li>MDCG 2021-3 \u2013 Technical Documentation Guidance<\/li>\n\n\n\n<li>ISO 13485:2016 \u2013 Medical Device Quality Management Systems<\/li>\n\n\n\n<li>ISO 15197:2013 \u2013 Blood Glucose Monitoring Systems<\/li>\n<\/ul>\n\n\n\n<h1 class=\"wp-block-heading\"><strong>B\u00f6l\u00fcm 5: Post-Market Clinical Follow-Up (PMCF) ve Vigilance S\u00fcre\u00e7leri \u2013 Detayl\u0131 Rehber<\/strong><\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">5.1 Giri\u015f: PMCF ve Vigilance Nedir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">T\u0131bbi cihazlar ve in vitro tan\u0131 cihazlar\u0131 (IVDs), <strong>piyasaya sunulduktan sonra da g\u00fcvenlik ve performans a\u00e7\u0131s\u0131ndan izlenmek zorundad\u0131r<\/strong>. MDR 2017\/745 ve IVDR 2017\/746 bu s\u00fcreci iki ana ba\u015fl\u0131k alt\u0131nda toplar:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Post-Market Clinical Follow-Up (PMCF):<\/strong> Cihaz\u0131n klinik performans\u0131n\u0131n piyasada s\u00fcrekli takip edilmesi ve klinik verilerle desteklenmesi.<\/li>\n\n\n\n<li><strong>Vigilance:<\/strong> Piyasada ortaya \u00e7\u0131kan advers olaylar\u0131n (AE) toplanmas\u0131, raporlanmas\u0131 ve analiz edilmesi s\u00fcreci.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Bu iki s\u00fcre\u00e7 birbirini tamamlar ve <strong>risk y\u00f6netimi, teknik dosya ve CE uygunluk beyan\u0131n\u0131n g\u00fcncel tutulmas\u0131n\u0131 sa\u011flar<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kaynaklar:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDR 2017\/745 Annex XIV Part B<\/li>\n\n\n\n<li>IVDR 2017\/746 Annex XIV Part B<\/li>\n\n\n\n<li>MDCG 2021-10 \u2013 Guidance on PMCF and Vigilance<\/li>\n\n\n\n<li>ISO 14155:2020 \u2013 Clinical Investigation of Medical Devices<\/li>\n\n\n\n<li>ISO 14971:2019 \u2013 Risk Management for Medical Devices<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">5.2 PMCF S\u00fcreci: Klinik Veri Toplama ve Analiz<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">5.2.1 PMCF\u2019nin Ama\u00e7lar\u0131<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Cihaz\u0131n piyasada <strong>tasar\u0131m ve kullan\u0131m amac\u0131na uygun performans g\u00f6sterdi\u011fini do\u011frulamak<\/strong>.<\/li>\n\n\n\n<li>Piyasaya \u00e7\u0131kt\u0131ktan sonra ortaya \u00e7\u0131kan <strong>yeni riskleri belirlemek<\/strong> ve risk y\u00f6netim dosyas\u0131n\u0131 g\u00fcncellemek.<\/li>\n\n\n\n<li>Cihaz\u0131n <strong>g\u00fcvenli\u011fini ve etkinli\u011fini s\u00fcrekli belgelemek<\/strong>, d\u00fczenleyici kurumlar\u0131n denetimine haz\u0131r hale getirmek.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek:<\/strong> Bir glikoz \u00f6l\u00e7\u00fcm stripi, evde veya klinikte kullan\u0131l\u0131rken yanl\u0131\u015f negatif \u00f6l\u00e7\u00fcm riski a\u00e7\u0131s\u0131ndan izlenmelidir. PMCF s\u00fcrecinde <strong>kullan\u0131c\u0131 verileri, advers olay raporlar\u0131 ve literat\u00fcr taramalar\u0131<\/strong> toplan\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">5.2.2 PMCF Plan\u0131 ve Uygulamas\u0131<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">PMCF plan\u0131, teknik dosyan\u0131n ayr\u0131lmaz bir par\u00e7as\u0131d\u0131r ve \u015funlar\u0131 i\u00e7erir:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Veri toplama y\u00f6ntemleri:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Klinik \u00e7al\u0131\u015fmalardan g\u00f6zlemsel veri toplama<\/li>\n\n\n\n<li>Literat\u00fcr taramalar\u0131 (PubMed, MDCG raporlar\u0131)<\/li>\n\n\n\n<li>Kullan\u0131c\u0131 anketleri ve geri bildirim<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Zaman \u00e7izelgesi:<\/strong> Periyodik veri toplama (6, 12, 24 ay gibi)<\/li>\n\n\n\n<li><strong>Risk analizi:<\/strong> Toplanan verilerin risk matrisi ile de\u011ferlendirilmesi<\/li>\n\n\n\n<li><strong>G\u00fcncelleme ve raporlama:<\/strong> CER ve teknik dosyan\u0131n revizyonu<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek PMCF Plan Tablosu:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Zaman<\/th><th>Veri T\u00fcr\u00fc<\/th><th>Numune<\/th><th>Risk \u0130zleme<\/th><th>Notlar<\/th><\/tr><\/thead><tbody><tr><td>6 Ay<\/td><td>Klinik veri<\/td><td>200<\/td><td>Orta<\/td><td>Kullan\u0131c\u0131 e\u011fitimi g\u00fcncellenecek<\/td><\/tr><tr><td>12 Ay<\/td><td>Advers olay<\/td><td>500<\/td><td>Y\u00fcksek<\/td><td>CAPA plan\u0131 uygulanacak<\/td><\/tr><tr><td>24 Ay<\/td><td>Literat\u00fcr taramas\u0131<\/td><td>&#8211;<\/td><td>D\u00fc\u015f\u00fck<\/td><td>Yeni bilimsel veriler takip edilecek<\/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\">5.2.3 PMCF Y\u00f6ntemleri ve \u00d6rnekler<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>G\u00f6zlemsel \u00e7al\u0131\u015fmalar:<\/strong> Ger\u00e7ek kullan\u0131m ortam\u0131nda cihaz performans\u0131n\u0131 izleme.\n<ul class=\"wp-block-list\">\n<li>\u00d6rnek: Diyabet hastalar\u0131n\u0131n evde kulland\u0131\u011f\u0131 glikoz striplerinin do\u011fruluk testi.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Klinik denemeler:<\/strong> Yeni cihazlar veya tasar\u0131m de\u011fi\u015fiklikleri i\u00e7in kontroll\u00fc \u00e7al\u0131\u015fmalar.\n<ul class=\"wp-block-list\">\n<li>\u00d6rnek: Yeni sens\u00f6r teknolojisi ile strip geli\u015ftirilmesi ve do\u011fruluk testi.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Literat\u00fcr taramas\u0131:<\/strong> MDCG rehberleri ve bilimsel yay\u0131nlardan veri toplama.\n<ul class=\"wp-block-list\">\n<li>\u00d6rnek: PubMed\u2019den son 5 y\u0131l\u0131n glikoz \u00f6l\u00e7\u00fcm strip performans verilerinin analizi.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Anket ve geri bildirim:<\/strong> Cihaz\u0131 kullanan sa\u011fl\u0131k profesyonellerinden veri toplama.\n<ul class=\"wp-block-list\">\n<li>\u00d6rnek: Ev kullan\u0131m\u0131 s\u0131ras\u0131nda olu\u015fan yanl\u0131\u015f \u00f6l\u00e7\u00fcm bildirimleri.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">5.3 Vigilance S\u00fcreci: Advers Olay Y\u00f6netimi<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">5.3.1 Tan\u0131m ve Kapsam<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Vigilance, cihaz\u0131n piyasada ortaya \u00e7\u0131kan <strong>advers olaylar\u0131n\u0131 (AE) sistematik olarak raporlama, analiz etme ve \u00f6nlem alma<\/strong> s\u00fcrecidir. MDR\/IVDR, <strong>yetkili makam ve notified body ile s\u00fcrekli ileti\u015fim<\/strong> kurulmas\u0131n\u0131 zorunlu k\u0131lar.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Advers olay (AE):<\/strong> Cihaz kullan\u0131m\u0131 s\u0131ras\u0131nda kullan\u0131c\u0131 veya hastada zarar olu\u015fmas\u0131<\/li>\n\n\n\n<li><strong>Serious Adverse Event (SAE):<\/strong> Hayati risk, hastaneye yat\u0131\u015f veya kal\u0131c\u0131 hasar<\/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\">5.3.2 AE Raporlama ve Analiz<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Olay\u0131n kayd\u0131:<\/strong> Kullan\u0131c\u0131 veya \u00fcretici taraf\u0131ndan bildirilen t\u00fcm AE\u2019ler kaydedilir.<\/li>\n\n\n\n<li><strong>Risk de\u011ferlendirmesi:<\/strong> Olay\u0131n \u015fiddeti, s\u0131kl\u0131\u011f\u0131 ve cihaz\u0131n rol\u00fc analiz edilir.<\/li>\n\n\n\n<li><strong>CAPA:<\/strong> Gerekti\u011finde d\u00fczeltici ve \u00f6nleyici aksiyonlar al\u0131n\u0131r.<\/li>\n\n\n\n<li><strong>Raporlama:<\/strong> Yetkili makam ve notified body\u2019ye <strong>zaman\u0131nda ve do\u011fru raporlama<\/strong> yap\u0131l\u0131r.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek AE Tablosu:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Tarih<\/th><th>Olay T\u00fcr\u00fc<\/th><th>Cihaz Modeli<\/th><th>\u015eiddet<\/th><th>Eylem<\/th><th>Notlar<\/th><\/tr><\/thead><tbody><tr><td>01\/2025<\/td><td>Yanl\u0131\u015f \u00f6l\u00e7\u00fcm<\/td><td>GT-2025<\/td><td>Orta<\/td><td>Yaz\u0131l\u0131m g\u00fcncellemesi<\/td><td>Kullan\u0131c\u0131 e\u011fitimi<\/td><\/tr><tr><td>03\/2025<\/td><td>Sens\u00f6r hatas\u0131<\/td><td>GT-2025<\/td><td>Y\u00fcksek<\/td><td>CAPA ba\u015flat\u0131ld\u0131<\/td><td>\u00dcretici bilgilendirildi<\/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\">5.3.3 PMCF ve Vigilance Entegrasyonu<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>PMCF\u2019den gelen veriler vigilance s\u00fcrecini <strong>besler<\/strong>.<\/li>\n\n\n\n<li>AE raporlar\u0131 risk y\u00f6netim dosyas\u0131nda g\u00fcncellenir.<\/li>\n\n\n\n<li>Bu d\u00f6ng\u00fc, cihaz\u0131n <strong>piyasada g\u00fcvenli ve etkin kalmas\u0131n\u0131 sa\u011flar<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6rnek Grafik:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Zaman i\u00e7indeki AE trendi<\/li>\n\n\n\n<li>PMCF ile risk seviyelerinin d\u00fc\u015f\u00fc\u015f grafi\u011fi<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">5.4 Vaka \u00c7al\u0131\u015fmas\u0131: Glikoz Test Strip GT-2025<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>PMCF:<\/strong> 6 ayda kullan\u0131c\u0131 geri bildirimi topland\u0131, 12 ayda AE analizi yap\u0131ld\u0131, 24 ayda literat\u00fcr taramas\u0131 tamamland\u0131.<\/li>\n\n\n\n<li><strong>Vigilance:<\/strong> Yanl\u0131\u015f \u00f6l\u00e7\u00fcm raporlar\u0131 CAPA ile d\u00fczeltildi, \u00fcreticiye bildirildi.<\/li>\n\n\n\n<li>Risk y\u00f6netim dosyas\u0131 ve CER revize edildi.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">5.5 SEO ve Kullan\u0131m \u00d6nerileri<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Anahtar kelimeler: \u201cMDR PMCF rehberi\u201d, \u201cIVDR vigilance s\u00fcre\u00e7leri\u201d, \u201ct\u0131bbi cihaz advers olay raporlama\u201d, \u201cMDCG PMCF \u00f6rnekleri\u201d<\/li>\n\n\n\n<li>Meta a\u00e7\u0131klama: \u201cMDR ve IVDR kapsam\u0131nda PMCF ve vigilance s\u00fcre\u00e7lerini detayl\u0131 \u015fekilde \u00f6\u011frenin. Klinik veri toplama, AE y\u00f6netimi, risk g\u00fcncelleme ve vaka \u00e7al\u0131\u015fmalar\u0131 ile rehber.\u201d<\/li>\n\n\n\n<li>\u0130\u00e7erik uzunlu\u011fu: 2500+ kelime hedefi<\/li>\n\n\n\n<li>G\u00f6rsel \u00f6nerisi: PMCF plan tablolar\u0131, AE trend grafikleri<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">5.6 Kaynaklar<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDR 2017\/745 \u2013 Annex XIV Part B<\/li>\n\n\n\n<li>IVDR 2017\/746 \u2013 Annex XIV Part B<\/li>\n\n\n\n<li>MDCG 2021-10 \u2013 Guidance on PMCF and Vigilance<\/li>\n\n\n\n<li>ISO 14155:2020 \u2013 Clinical Investigation of Medical Devices<\/li>\n\n\n\n<li>ISO 14971:2019 \u2013 Risk Management for Medical Devices<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>B\u00f6l\u00fcm 1: MDR ve IVDR\u2019e Genel Bak\u0131\u015f, Yasal \u00c7er\u00e7eve ve Risk S\u0131n\u0131fland\u0131rmas\u0131 1.1 Giri\u015f MDR (Medical Device Regulation, EU 2017\/745) [&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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