{"id":618,"date":"2026-02-25T10:14:40","date_gmt":"2026-02-25T07:14:40","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?p=618"},"modified":"2026-05-15T11:05:58","modified_gmt":"2026-05-15T08:05:58","slug":"mdr-cer-deficiencies-notified-bodies","status":"publish","type":"post","link":"https:\/\/www.bplussolutions.com\/tr\/mdr-cer-deficiencies-notified-bodies\/","title":{"rendered":"Onaylanm\u0131\u015f Kurulu\u015flar\u0131n En S\u0131k Tespit Etti\u011fi 5 MDR CER Eksikli\u011fi"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"618\" class=\"elementor elementor-618\" data-elementor-settings=\"{&quot;element_pack_global_tooltip_width&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_padding&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3f645d7 e-flex e-con-boxed e-con e-parent\" data-id=\"3f645d7\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d347143 elementor-widget elementor-widget-text-editor\" data-id=\"3d347143\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p style=\"font-weight: 400;\">MDR (EU) 2017\/745 kapsam\u0131nda, Klinik De\u011ferlendirme Raporlar\u0131 (CER) \u00e7ok daha kapsaml\u0131 bir incelemeye tabi tutuluyor. Onaylanm\u0131\u015f Kurulu\u015flar\u0131n (Notified Body, NB) yayg\u0131n olarak kulland\u0131\u011f\u0131 inceleme yap\u0131lar\u0131 ve CEAR de\u011ferlendirme \u015fablonlar\u0131 incelendi\u011finde, uygunluk de\u011ferlendirmeleri s\u0131ras\u0131nda en s\u0131k kar\u015f\u0131la\u015f\u0131lan be\u015f eksiklik a\u015fa\u011f\u0131da \u00f6zetlenmi\u015ftir.<\/p><h2>1. Klinik De\u011ferlendirme Plan\u0131n\u0131n (CEP) Annex XIV ile Yetersiz Uyumu<\/h2><p style=\"font-weight: 400;\">En s\u0131k kar\u015f\u0131la\u015f\u0131lan bulgulardan biri, CEP\u2019in Annex XIV Part A gerekliliklerini tam olarak kar\u015f\u0131lamamas\u0131d\u0131r.<\/p><p style=\"font-weight: 400;\">Yayg\u0131n olarak g\u00f6r\u00fclen sorunlar:<\/p><ul><li>Klinik kan\u0131t d\u00fczeyine ili\u015fkin gerek\u00e7enin eksik olmas\u0131<\/li><li>Klinik veri gerektiren GSPR\u2019lerin a\u00e7\u0131k\u00e7a belirlenmemi\u015f olmas\u0131<\/li><li>Klinik fayda son noktalar\u0131n\u0131n tan\u0131mlanmam\u0131\u015f olmas\u0131<\/li><li>Fayda risk kabul kriterlerinin zay\u0131f tan\u0131mlanm\u0131\u015f olmas\u0131<\/li><li>PMCF planlamas\u0131n\u0131n y\u00fczeysel kalmas\u0131<\/li><\/ul><p style=\"font-weight: 400;\">Onaylanm\u0131\u015f Kurulu\u015flar, CEP i\u00e7eri\u011finin Annex XIV ve MDCG 2020-13 gerekliliklerini kar\u015f\u0131lay\u0131p kar\u015f\u0131lamad\u0131\u011f\u0131n\u0131 ayr\u0131ca do\u011frular. CEP zay\u0131f kald\u0131\u011f\u0131nda, CER\u2019in t\u00fcm temeli sars\u0131l\u0131r.<\/p><h2>2. Klinik G\u00fcvenlik ve Rezid\u00fcel Risk Analizinin Yetersiz G\u00f6sterilmesi<\/h2><p style=\"font-weight: 400;\">Bir di\u011fer \u00f6nemli eksiklik, klinik g\u00fcvenlik de\u011ferlendirmesinin yap\u0131sal olarak yetersiz haz\u0131rlanmas\u0131d\u0131r.<\/p><p style=\"font-weight: 400;\">S\u0131k g\u00f6r\u00fclen problemler:<\/p><ul><li>Yap\u0131land\u0131r\u0131lm\u0131\u015f nitel ve nicel g\u00fcvenlik analizinin yap\u0131lmamas\u0131<\/li><li>Kalan risklerin net olarak belirlenmemesi<\/li><li>Yan etkilerin veri tabanl\u0131 de\u011ferlendirme olmadan listelenmesi<\/li><li>Risk y\u00f6netimi dok\u00fcmantasyonu ile zay\u0131f hizalanma<\/li><\/ul><p style=\"font-weight: 400;\">NB de\u011ferlendiricileri \u015fu konular\u0131 kontrol eder:<\/p><ul><li>Klinik g\u00fcvenlik y\u00f6ntemlerinin tan\u0131mlan\u0131p tan\u0131mlanmad\u0131\u011f\u0131<\/li><li>Kalan risklerin gerek\u00e7elendirilip gerek\u00e7elendirilmedi\u011fi<\/li><li>Normal kullan\u0131m ko\u015fullar\u0131 alt\u0131nda fayda risk dengesinin kabul edilebilir kal\u0131p kalmad\u0131\u011f\u0131<\/li><\/ul><p style=\"font-weight: 400;\">G\u00fcvenli\u011fi yap\u0131land\u0131r\u0131lm\u0131\u015f bir analiz olmaks\u0131z\u0131n \u00f6zetleyen bir CER, \u00e7o\u011funlukla reddedilir.<\/p><h2>3. Zay\u0131f E\u015fde\u011ferlik Gerek\u00e7esi (Annex XIV B\u00f6l\u00fcm 3)<\/h2><p style=\"font-weight: 400;\">E\u015fde\u011ferlik, MDR kapsam\u0131nda en yanl\u0131\u015f anla\u015f\u0131lan alanlardan biridir.<\/p><p style=\"font-weight: 400;\">Yayg\u0131n NB bulgular\u0131:<\/p><ul><li>Yaln\u0131zca teknik benzerli\u011fin g\u00f6sterilmesi<\/li><li>Biyolojik e\u015fde\u011ferli\u011fin kan\u0131tlanmam\u0131\u015f olmas\u0131<\/li><li>Klinik e\u015fde\u011ferli\u011fin yetersiz gerek\u00e7elendirilmesi<\/li><li>E\u015fde\u011fer cihaza ait verilere eri\u015fimin bulunmamas\u0131<\/li><li>S\u00f6zle\u015fmenin bulunmamas\u0131 (S\u0131n\u0131f III ve implant edilebilir cihazlar i\u00e7in)<\/li><\/ul><p style=\"font-weight: 400;\">MDR, \u00fc\u00e7 boyutun ayn\u0131 anda kan\u0131tlanmas\u0131n\u0131 gerektirir:<\/p><ul><li>Teknik e\u015fde\u011ferlik<\/li><li>Biyolojik e\u015fde\u011ferlik<\/li><li>Klinik e\u015fde\u011ferlik<\/li><\/ul><p style=\"font-weight: 400;\">Bu \u00fc\u00e7 s\u00fctundan herhangi birindeki eksiklik, maj\u00f6r bir uygunsuzluk olarak de\u011ferlendirilir.<\/p><h2>4. Yetersiz Literat\u00fcr Tarama Metodolojisi<\/h2><p style=\"font-weight: 400;\">Bir CER \u00e7ok say\u0131da referans i\u00e7erebilir, ancak metodolojik a\u00e7\u0131dan zay\u0131f kalabilir.<\/p><p style=\"font-weight: 400;\">Tipik NB endi\u015feleri:<\/p><ul><li>Tan\u0131ml\u0131 bir arama protokol\u00fcn\u00fcn bulunmamas\u0131<\/li><li>Dahil etme ve d\u0131\u015flama kriterlerinin eksik olmas\u0131<\/li><li>PRISMA ak\u0131\u015f\u0131n\u0131n yer almamas\u0131<\/li><li>Tekrar (duplikasyon) kontrol stratejisinin olu\u015fturulmamas\u0131<\/li><li>Olumsuz verilerin tart\u0131\u015f\u0131lmamas\u0131<\/li><\/ul><p style=\"font-weight: 400;\">Onaylanm\u0131\u015f Kurulu\u015flar, literat\u00fcr taramas\u0131n\u0131n PRISMA, PICO veya CENTRAL gibi sistematik ve nesnel kriterleri takip edip etmedi\u011fini de\u011ferlendirir.<\/p><p style=\"font-weight: 400;\">Makale say\u0131s\u0131, metodolojik titizli\u011fin yerine ge\u00e7mez.<\/p><h2>5. PMS ve PMCF\u2019nin CER\u2019e Yetersiz Entegrasyonu<\/h2><p style=\"font-weight: 400;\">MDR, klinik de\u011ferlendirmeyi s\u00fcrekli i\u015fleyen bir s\u00fcre\u00e7 olarak tan\u0131mlar.<\/p><p style=\"font-weight: 400;\">S\u0131k g\u00f6r\u00fclen eksiklikler:<\/p><ul><li>CER g\u00fcncelleme s\u0131kl\u0131\u011f\u0131n\u0131n gerek\u00e7elendirilmemi\u015f olmas\u0131<\/li><li>PMCF\u2019nin tan\u0131mlanm\u0131\u015f risklerle a\u00e7\u0131k\u00e7a ili\u015fkilendirilmemesi<\/li><li>PMS verilerinin \u00f6zetlenmesi, ancak klinik olarak yorumlanmamas\u0131<\/li><li>Pazar sonras\u0131 veriler ile fayda risk sonucu aras\u0131nda geri besleme d\u00f6ng\u00fcs\u00fcn\u00fcn kurulmamas\u0131<\/li><\/ul><p style=\"font-weight: 400;\">NB \u015fablonlar\u0131 a\u00e7\u0131k\u00e7a \u015fu noktalar\u0131 de\u011ferlendirir:<\/p><ul><li>PMS Plan\u0131 referans\u0131<\/li><li>PMCF Plan\u0131 yeterlili\u011fi<\/li><li>PSUR entegrasyonu<\/li><li>G\u00fcncelleme d\u00fczenlili\u011fi<\/li><\/ul><p style=\"font-weight: 400;\">PMS s\u00fcrecinden kopuk bir CER, MDR kapsam\u0131nda uygunsuz olarak de\u011ferlendirilir.<\/p><h2>Bu Eksiklikler Neden \u00d6nemli?<\/h2><p style=\"font-weight: 400;\">MDR kapsam\u0131nda klinik de\u011ferlendirme, art\u0131k bir literat\u00fcr \u00f6zeti de\u011fildir. Aksine, a\u015fa\u011f\u0131daki unsurlar\u0131 kan\u0131tlayan yap\u0131land\u0131r\u0131lm\u0131\u015f bir d\u00fczenleyici arg\u00fcmand\u0131r:<\/p><ul><li>GSPR uygunlu\u011fu<\/li><li>Klinik g\u00fcvenlik<\/li><li>Klinik performans<\/li><li>Kabul edilebilir fayda risk profili<\/li><li>S\u00fcrekli pazar sonras\u0131 do\u011frulama<\/li><\/ul><p style=\"font-weight: 400;\">Onaylanm\u0131\u015f Kurulu\u015flar bu de\u011ferlendirmeyi yap\u0131land\u0131r\u0131lm\u0131\u015f CEAR \u00e7er\u00e7eveleri \u00fczerinden y\u00fcr\u00fct\u00fcr. Bu nedenle, zay\u0131f noktalar inceleme s\u00fcrecinde h\u0131zla belirgin hale gelir.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4b22ad2 e-flex e-con-boxed e-con e-parent\" data-id=\"4b22ad2\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5827469 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"5827469\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.bplussolutions.com\/tr\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00d6zel Dan\u0131\u015fma Talebi Olu\u015fturun<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Under MDR (EU) 2017\/745, Clinical Evaluation Reports (CERs) are reviewed with significantly increased scrutiny. Based on the review structures commonly used by Notified Bodies (NBs) and the CEAR assessment templates, the following five deficiencies are most frequently identified during conformity assessments. 1. Inadequate Alignment of the Clinical Evaluation Plan (CEP) with Annex XIV One of [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-618","post","type-post","status-publish","format-standard","hentry","category-insights"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Top 5 MDR CER Deficiencies Identified by Notified Bodies - B+ SOLUTIONS<\/title>\n<meta name=\"description\" content=\"Top 5 MDR CER deficiencies identified by Notified Bodies under EU MDR 2017\/745. 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