{"id":662,"date":"2026-03-06T11:41:33","date_gmt":"2026-03-06T08:41:33","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?p=662"},"modified":"2026-05-13T11:53:30","modified_gmt":"2026-05-13T08:53:30","slug":"what-is-a-notified-body-and-what-are-its-responsibilities","status":"publish","type":"post","link":"https:\/\/www.bplussolutions.com\/tr\/what-is-a-notified-body-and-what-are-its-responsibilities\/","title":{"rendered":"Onaylanm\u0131\u015f Kurulu\u015f Nedir ve Sorumluluklar\u0131 Nelerdir?"},"content":{"rendered":"
\n\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t

Bir Onaylanm\u0131\u015f Kurulu\u015f d\u00fczenleyici bir otorite de\u011fildir. Bu tek c\u00fcmle, \u00fcreticilerin bir a\u00e7\u0131l\u0131\u015f toplant\u0131s\u0131na getirdi\u011fi kafa kar\u0131\u015f\u0131kl\u0131\u011f\u0131n\u0131n yar\u0131s\u0131n\u0131 \u00e7\u00f6zer.<\/p>

(EU) 2017\/745 say\u0131l\u0131 T\u00fcz\u00fck (MDR) \u00e7er\u00e7evesinde Onaylanm\u0131\u015f Kurulu\u015f, bir \u00dcye Devlet taraf\u0131ndan Madde 35 kapsam\u0131nda atanm\u0131\u015f, Avrupa Komisyonu\u2019na bildirilmi\u015f ve NANDO veri taban\u0131na d\u00f6rt haneli bir kimlik numaras\u0131 ile belirli bir kapsamla kaydedilmi\u015f bir uygunluk de\u011ferlendirme kurulu\u015fudur. \u00dcreticilerin en \u00e7ok atlad\u0131\u011f\u0131 konu kapsamd\u0131r. \u0130ki Onaylanm\u0131\u015f Kurulu\u015f da \u201cMDR kapsam\u0131nda atanm\u0131\u015f\u201d olabilir, ama tamamen farkl\u0131 cihaz kategorilerini, sterilizasyon teknolojilerini veya \u00f6l\u00e7me fonksiyonu \u00f6zelliklerini kapsayabilir. Bunu bro\u015f\u00fcr s\u00f6ylemez. NANDO listesi s\u00f6yler.<\/p>

Bir kurulu\u015f nas\u0131l onaylanm\u0131\u015f hale gelir<\/h2>

S\u00fcre\u00e7 Madde 35\u2019ten 50\u2019ye kadar tan\u0131ml\u0131d\u0131r. Ba\u015fvuran kurulu\u015f ulusal yetkilendirme otoritesine ba\u015fvurur, otorite \u00f6n de\u011ferlendirmeyi yapar. T\u0131bbi Cihaz Koordinasyon Grubu ve Avrupa Komisyonu daha sonra ortak de\u011ferlendirme yapar, ba\u015fka \u00dcye Devletlerden gelen de\u011ferlendiricilerden olu\u015fan bir ekibi ba\u015fvuran kurulu\u015fa g\u00f6nderir. Bu ekip dosyalar\u0131 inceler, denetimlere g\u00f6zlemci olarak kat\u0131l\u0131r ve talep edilen kapsam kodlar\u0131ndaki yetkinli\u011fi yak\u0131ndan sorgular. Yetkilendirme kapsam baz\u0131nda verilir, sonras\u0131nda periyodik yeniden de\u011ferlendirmeler izler.<\/p>

Bu y\u00fczden \u201cMDA 0301 kodu alt\u0131ndaki cihaz\u0131m\u0131z\u0131 sertifikaland\u0131rabilir misiniz\u201d sorusunun cevab\u0131 bazen \u201chen\u00fcz de\u011fil, o kod yetkilendirmemizde h\u00e2l\u00e2 beklemede\u201d olur. Oyalama gibi duysa da bu, Onaylanm\u0131\u015f Kurulu\u015f taraf\u0131nda ger\u00e7ek bir k\u0131s\u0131tt\u0131r.<\/p>

Bir de\u011ferlendirme asl\u0131nda neyi i\u00e7erir<\/h2>

MDR, uygunluk de\u011ferlendirme rotalar\u0131n\u0131 Ek IX, X ve XI\u2019de tan\u0131mlar. \u00dcreticilerin \u00e7o\u011fu Ek IX rotas\u0131nda olacakt\u0131r, bu rota bir kalite y\u00f6netim sistemi denetimi ile teknik dok\u00fcmantasyon de\u011ferlendirmesini birle\u015ftirir.<\/p>

KYS denetimi, ger\u00e7ekten nas\u0131l \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131za bakar. Tasar\u0131m kontrolleri, ISO 14971\u2019e uyumlu risk y\u00f6netimi, tedarik\u00e7i kontrolleri, CAPA, Madde 83 ila 92 gereklilikleri kar\u015f\u0131s\u0131nda piyasaya arz sonras\u0131 g\u00f6zetim ve vijilans, ve PMS verileriniz ile Ek XIV kapsam\u0131ndaki klinik de\u011ferlendirmeniz aras\u0131ndaki ba\u011flant\u0131. Denet\u00e7iler yaz\u0131l\u0131 prosed\u00fcrlerinizin olup olmad\u0131\u011f\u0131n\u0131 \u00f6l\u00e7mek i\u00e7in orada de\u011fildir. Yaz\u0131l\u0131 prosed\u00fcr neredeyse herkeste vard\u0131r. Onlar prosed\u00fcrlerin sahada ve tasar\u0131m ofisinde fiilen yap\u0131lan i\u015fle \u00f6rt\u00fc\u015f\u00fcp \u00f6rt\u00fc\u015fmedi\u011fini test eder.<\/p>

Teknik dok\u00fcmantasyon de\u011ferlendirmesi ayr\u0131 bir i\u015f ak\u0131\u015f\u0131d\u0131r; teknik dosyan\u0131n kendisi Ek II, piyasaya arz sonras\u0131 dok\u00fcmantasyon Ek III alt\u0131nda y\u00fcr\u00fcr. S\u0131n\u0131f III ve baz\u0131 S\u0131n\u0131f IIb implantlar i\u00e7in her teknik dosya bu incelemeden ge\u00e7er. Di\u011fer S\u0131n\u0131f IIb ve S\u0131n\u0131f IIa cihazlar i\u00e7in Onaylanm\u0131\u015f Kurulu\u015f, Ek IX\u2019daki kurallara g\u00f6re \u00f6rnekleme yapar. De\u011ferlendirici cihaz\u0131n Ek I\u2019deki Genel G\u00fcvenlik ve Performans Gerekliliklerine uyup uymad\u0131\u011f\u0131n\u0131, Ek XIV kapsam\u0131ndaki klinik de\u011ferlendirmenin iddialar\u0131 destekleyip desteklemedi\u011fini ve etiketleme ile kullan\u0131m talimat\u0131n\u0131n kan\u0131tla \u00f6rt\u00fc\u015f\u00fcp \u00f6rt\u00fc\u015fmedi\u011fini sorgular.<\/p>

Kan\u0131t iddiay\u0131 desteklemiyorsa ya iddia de\u011fi\u015fmek zorundad\u0131r ya da kan\u0131t. \u00dcreticiler bazen \u00fc\u00e7\u00fcnc\u00fc bir se\u00e7ene\u011fi \u00f6ne s\u00fcrmeye \u00e7al\u0131\u015f\u0131r, o da de\u011ferlendiricinin iddiay\u0131 yine de kabul etmesi gerekti\u011fidir. Bunun i\u015fledi\u011fi bir ba\u015fvuru g\u00f6rmedim.<\/p>

Eksiklik d\u00f6ng\u00fcs\u00fc i\u015fin as\u0131l y\u00fck\u00fc<\/h2>

Bir teknik dosya incelemesinde g\u00f6r\u00fcnen i\u015fin \u00e7o\u011fu eksiklik d\u00f6ng\u00fcs\u00fcd\u00fcr. De\u011ferlendirici bulgular yazar, \u00fcretici cevap verir, de\u011ferlendirici cevab\u0131 de\u011ferlendirir, ya bulguyu kapat\u0131r ya da yeni bir takip bulgusu a\u00e7ar. Her tur takvime g\u00fcn ekler. Klinik kan\u0131t\u0131 zay\u0131f veya risk fayda analizi mu\u011flak ba\u015fvurular s\u0131kl\u0131kla \u00fc\u00e7 d\u00f6rt turda \u00e7\u00f6z\u00fcl\u00fcr. Tasar\u0131m gerek\u00e7esi iyi belgelenmi\u015f ve GSPR kontrol listesi ger\u00e7ekten kan\u0131tla ili\u015fkilendirilmi\u015f ba\u015fvurular genellikle bir iki turda kapan\u0131r.<\/p>

\u0130nceleme s\u00fcrecinde en h\u0131zl\u0131 ilerleyen teknik dosyalar, en basit cihazlar\u0131n dosyalar\u0131 de\u011fildi. \u00dcreticinin de\u011ferlendiricinin sorular\u0131n\u0131 \u00f6nceden \u00f6ng\u00f6rd\u00fc\u011f\u00fc dosyalard\u0131.<\/p>

G\u00f6zetim sertifikayla bitmez<\/h2>

Sertifika, verildi\u011fi andaki uygunlu\u011fun bir foto\u011fraf\u0131d\u0131r. \u0130mzaland\u0131\u011f\u0131 g\u00fcnden itibaren Onaylanm\u0131\u015f Kurulu\u015f, MDR\u2019nin 56. Maddesi kapsam\u0131nda s\u00fcrekli g\u00f6zetimden sorumludur. Buna y\u0131ll\u0131k g\u00f6zetim denetimleri, teknik dok\u00fcmantasyonun periyodik yeniden de\u011ferlendirilmesi, EUDAMED\u2019den ve kurulu\u015fun kendi dosyalar\u0131ndan gelen vijilans sinyalleri, ve (EU) 920\/2013 say\u0131l\u0131 Komisyon Uygulama T\u00fcz\u00fc\u011f\u00fc\u2019nde tan\u0131mlanan habersiz denetimler dahildir.<\/p>

\u00dcreticilerin en \u00e7ok hafife ald\u0131\u011f\u0131 k\u0131s\u0131m habersiz denetimlerdir. Denetim ekibi yasal \u00fcreticiye, kritik alt y\u00fcklenicilere veya \u00f6nemli tedarik\u00e7ilere haber vermeden gelebilir, \u00fcr\u00fcn \u00e7ekebilir, test sonu\u00e7lar\u0131 talep edebilir, \u00fcretimi yerinde g\u00f6zlemleyebilir. Eri\u015fim reddedilirse kurulu\u015f, sertifikay\u0131 Madde 56 kapsam\u0131nda ask\u0131ya alabilir veya geri \u00e7ekebilir.<\/p>

De\u011fi\u015fikliklerin de dosyaya geri akmas\u0131 gerekir. Kullan\u0131m amac\u0131nda, tasar\u0131mda, malzemede, sterilizasyon y\u00f6nteminde veya \u00fcretim sahas\u0131nda bir de\u011fi\u015fiklik, \u00fcreticinin \u201ck\u00fc\u00e7\u00fck\u201d oldu\u011funa karar verece\u011fi bir \u015fey de\u011fildir. Ek IX ve Ek VII, esasl\u0131 de\u011fi\u015fikliklerin Onaylanm\u0131\u015f Kurulu\u015fa nas\u0131l bildirilece\u011fini ve uygulanmadan \u00f6nce nas\u0131l onaylanmas\u0131 gerekti\u011fini ortaya koyar. Esasl\u0131 \u015fekilde de\u011fi\u015fmi\u015f bir cihaz\u0131 eski sertifika alt\u0131nda piyasaya s\u00fcrmek, sistemde g\u00f6rd\u00fc\u011f\u00fcm\u00fcz en s\u0131k ve en pahal\u0131 hatalardan biridir.<\/p>

Onaylanm\u0131\u015f Kurulu\u015f neden dan\u0131\u015fmanl\u0131k veremez<\/h2>

\u00dcreticileri en \u00e7ok rahats\u0131z eden konu budur. Ek VII\u2019deki ba\u011f\u0131ms\u0131zl\u0131k ve tarafs\u0131zl\u0131k \u015fartlar\u0131, bir Onaylanm\u0131\u015f Kurulu\u015fun m\u00fc\u015fterilerine uyumun nas\u0131l sa\u011flanaca\u011f\u0131, cihaz\u0131n nas\u0131l tasarlanaca\u011f\u0131 veya teknik dosyan\u0131n nas\u0131l yaz\u0131laca\u011f\u0131 konusunda dan\u0131\u015fmanl\u0131k vermesini yasaklar. Ayn\u0131 \u015fart kurulu\u015fun personeli, ana \u015firketi ve ba\u011fl\u0131 \u015firketleri i\u00e7in de ge\u00e7erlidir.<\/p>

Pratikte bu, bir denet\u00e7inin kan\u0131t\u0131n iddiay\u0131 desteklemedi\u011fini size s\u00f6yleyebilece\u011fi, ama hangi kan\u0131t\u0131 \u00fcretmeniz gerekti\u011fini s\u00f6yleyemeyece\u011fi anlam\u0131na gelir. Bu bir m\u00fc\u015fteri hizmeti hatas\u0131 de\u011fildir. Kurulu\u015fun sonunda kendi i\u015fini sertifikaland\u0131rmas\u0131n\u0131 engelleyen yap\u0131sal bir g\u00fcvenlik duvar\u0131d\u0131r. Dosyan\u0131z\u0131 kurman\u0131za yard\u0131mc\u0131 olacak birine ihtiyac\u0131n\u0131z varsa bir dan\u0131\u015fmanl\u0131k \u015firketi tutars\u0131n\u0131z. Onaylanm\u0131\u015f Kurulu\u015f yaln\u0131zca sundu\u011funuzu de\u011ferlendirir.<\/p>

\u00c7o\u011fu ba\u015fvuru nerede tak\u0131l\u0131r<\/h2>

G\u00f6rd\u00fc\u011f\u00fcm gecikmelerin \u00e7o\u011fu birka\u00e7 noktada d\u00fc\u011f\u00fcmleniyor ve bunlar\u0131n hepsi dosya \u00fcreticinin masas\u0131ndan \u00e7\u0131kmadan \u00f6nce g\u00f6r\u00fclebilen \u015feyler.<\/p>

Se\u00e7ilen Onaylanm\u0131\u015f Kurulu\u015fun NANDO kapsam\u0131, cihaz s\u0131n\u0131f\u0131n\u0131z\u0131, kodunuzu ve steril olma, \u00f6l\u00e7me fonksiyonu veya hayvansal k\u00f6kenli malzeme kullan\u0131m\u0131 gibi \u00f6zel karakteristikleri ger\u00e7ekten i\u00e7ermelidir. Yanl\u0131\u015f e\u015fle\u015fmi\u015f bir kapsam, dosyan\u0131n kabul a\u015famas\u0131nda reddedilmesi demektir, sertifikan\u0131n ge\u00e7 verilmesi de\u011fil.<\/p>

Di\u011fer tekrar eden sorun, Ek I, Ek II ve Ek XIV aras\u0131ndaki izlenebilirliktir. Genel G\u00fcvenlik ve Performans Gereklilikleri standartt\u0131r. Teknik dok\u00fcmantasyon ispatt\u0131r. Klinik de\u011ferlendirme, iddialar ile kan\u0131tlar aras\u0131ndaki k\u00f6pr\u00fcd\u00fcr. Bu \u00fc\u00e7\u00fc g\u00f6r\u00fcn\u00fcr \u015fekilde birbirine ba\u011flanm\u0131yorsa teknik dosya hayat\u0131n\u0131 eksiklik d\u00f6ng\u00fcs\u00fcnde ge\u00e7irir.<\/p>

Bir de \u00fcreticilerin sertifikadan sonraya b\u0131rakt\u0131\u011f\u0131 piyasaya arz sonras\u0131 d\u00f6ng\u00fc var. Madde 83 ila 92 kapsam\u0131ndaki PMS, PSUR, PMCF ve vijilans, sertifikadan sonra ba\u015flayan bir \u00f6dev de\u011fildir. Bunlar sertifikan\u0131n ko\u015fullar\u0131d\u0131r ve Onaylanm\u0131\u015f Kurulu\u015flar, \u00fcreticinin bu d\u00f6ng\u00fcy\u00fc ne kadar ciddiye ald\u0131\u011f\u0131na ilk g\u00f6zetim denetiminden \u00e7ok \u00f6nce dikkat eder.<\/p>

Onaylanm\u0131\u015f Kurulu\u015f, \u00fcretici ile pazar aras\u0131ndaki ba\u011f\u0131ms\u0131z kontrold\u00fcr. S\u00fcre\u00e7ten en h\u0131zl\u0131 ge\u00e7en ba\u015fvurular, d\u0131\u015far\u0131dan bak\u0131ld\u0131\u011f\u0131nda sanki de\u011ferlendirici i\u00e7in yaz\u0131lm\u0131\u015f gibi duran ba\u015fvurulard\u0131r.<\/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

\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t

MDR kapsam\u0131nda bir Onaylanm\u0131\u015f Kurulu\u015f de\u011ferlendirmesine mi haz\u0131rlan\u0131yorsunuz?<\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tBize Ula\u015f\u0131n<\/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":"

A Notified Body is not a regulator. That single sentence clears up half of the confusion manufacturers bring into a kickoff meeting. Under Regulation (EU) 2017\/745 (MDR), a Notified Body is a conformity assessment body designated under Article 35 by a Member State, notified to the European Commission, and listed in the NANDO database with […]<\/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-662","post","type-post","status-publish","format-standard","hentry","category-insights"],"yoast_head":"\nWhat Is a Notified Body under MDR? Roles and Responsibilities<\/title>\n<meta name=\"description\" content=\"What is a Notified Body under MDR? Learn the role, responsibilities, and authority of Notified Bodies in the EU medical device conformity assessment process.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bplussolutions.com\/tr\/what-is-a-notified-body-and-what-are-its-responsibilities\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What Is a Notified Body under MDR? Roles and Responsibilities\" \/>\n<meta property=\"og:description\" content=\"What is a Notified Body under MDR? Learn the role, responsibilities, and authority of Notified Bodies in the EU medical device conformity assessment process.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.bplussolutions.com\/tr\/what-is-a-notified-body-and-what-are-its-responsibilities\/\" \/>\n<meta property=\"og:site_name\" content=\"B+ SOLUTIONS\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-06T08:41:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-13T08:53:30+00:00\" \/>\n<meta name=\"author\" content=\"beliz-admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Yazan:\" \/>\n\t<meta name=\"twitter:data1\" content=\"beliz-admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tahmini okuma s\u00fcresi\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 dakika\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/\"},\"author\":{\"name\":\"beliz-admin\",\"@id\":\"https:\/\/www.bplussolutions.com\/#\/schema\/person\/ad19ba15a95e65cf6e772ccd66fb5c95\"},\"headline\":\"What Is a Notified Body and What Are Its Responsibilities?\",\"datePublished\":\"2026-03-06T08:41:33+00:00\",\"dateModified\":\"2026-05-13T08:53:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/\"},\"wordCount\":1176,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.bplussolutions.com\/#organization\"},\"articleSection\":[\"Insights\"],\"inLanguage\":\"tr\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/\",\"url\":\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/\",\"name\":\"What Is a Notified Body under MDR? Roles and Responsibilities\",\"isPartOf\":{\"@id\":\"https:\/\/www.bplussolutions.com\/#website\"},\"datePublished\":\"2026-03-06T08:41:33+00:00\",\"dateModified\":\"2026-05-13T08:53:30+00:00\",\"description\":\"What is a Notified Body under MDR? Learn the role, responsibilities, and authority of Notified Bodies in the EU medical device conformity assessment process.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/#breadcrumb\"},\"inLanguage\":\"tr\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.bplussolutions.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"What Is a Notified Body and What Are Its Responsibilities?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.bplussolutions.com\/#website\",\"url\":\"https:\/\/www.bplussolutions.com\/\",\"name\":\"B+ SOLUTIONS\",\"description\":\"Smart Medical Device Solutions - Trusted Partnership\",\"publisher\":{\"@id\":\"https:\/\/www.bplussolutions.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.bplussolutions.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"tr\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.bplussolutions.com\/#organization\",\"name\":\"B+ SOLUTIONS\",\"url\":\"https:\/\/www.bplussolutions.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"tr\",\"@id\":\"https:\/\/www.bplussolutions.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.bplussolutions.com\/wp-content\/uploads\/2024\/10\/bplus-logo-2.png\",\"contentUrl\":\"https:\/\/www.bplussolutions.com\/wp-content\/uploads\/2024\/10\/bplus-logo-2.png\",\"width\":1311,\"height\":98,\"caption\":\"B+ SOLUTIONS\"},\"image\":{\"@id\":\"https:\/\/www.bplussolutions.com\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.bplussolutions.com\/#\/schema\/person\/ad19ba15a95e65cf6e772ccd66fb5c95\",\"name\":\"beliz-admin\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"tr\",\"@id\":\"https:\/\/www.bplussolutions.com\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/653276de7314b473c5b0336ef151e31893f3504ad49df44f9014faf2b899d924?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/653276de7314b473c5b0336ef151e31893f3504ad49df44f9014faf2b899d924?s=96&d=mm&r=g\",\"caption\":\"beliz-admin\"},\"url\":\"https:\/\/www.bplussolutions.com\/tr\/author\/beliz-admin\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"What Is a Notified Body under MDR? Roles and Responsibilities","description":"What is a Notified Body under MDR? Learn the role, responsibilities, and authority of Notified Bodies in the EU medical device conformity assessment process.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.bplussolutions.com\/tr\/what-is-a-notified-body-and-what-are-its-responsibilities\/","og_locale":"tr_TR","og_type":"article","og_title":"What Is a Notified Body under MDR? Roles and Responsibilities","og_description":"What is a Notified Body under MDR? Learn the role, responsibilities, and authority of Notified Bodies in the EU medical device conformity assessment process.","og_url":"https:\/\/www.bplussolutions.com\/tr\/what-is-a-notified-body-and-what-are-its-responsibilities\/","og_site_name":"B+ SOLUTIONS","article_published_time":"2026-03-06T08:41:33+00:00","article_modified_time":"2026-05-13T08:53:30+00:00","author":"beliz-admin","twitter_card":"summary_large_image","twitter_misc":{"Yazan:":"beliz-admin","Tahmini okuma s\u00fcresi":"6 dakika"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/#article","isPartOf":{"@id":"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/"},"author":{"name":"beliz-admin","@id":"https:\/\/www.bplussolutions.com\/#\/schema\/person\/ad19ba15a95e65cf6e772ccd66fb5c95"},"headline":"What Is a Notified Body and What Are Its Responsibilities?","datePublished":"2026-03-06T08:41:33+00:00","dateModified":"2026-05-13T08:53:30+00:00","mainEntityOfPage":{"@id":"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/"},"wordCount":1176,"commentCount":0,"publisher":{"@id":"https:\/\/www.bplussolutions.com\/#organization"},"articleSection":["Insights"],"inLanguage":"tr","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/","url":"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/","name":"What Is a Notified Body under MDR? Roles and Responsibilities","isPartOf":{"@id":"https:\/\/www.bplussolutions.com\/#website"},"datePublished":"2026-03-06T08:41:33+00:00","dateModified":"2026-05-13T08:53:30+00:00","description":"What is a Notified Body under MDR? Learn the role, responsibilities, and authority of Notified Bodies in the EU medical device conformity assessment process.","breadcrumb":{"@id":"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/#breadcrumb"},"inLanguage":"tr","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.bplussolutions.com\/what-is-a-notified-body-and-what-are-its-responsibilities\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.bplussolutions.com\/"},{"@type":"ListItem","position":2,"name":"What Is a Notified Body and What Are Its Responsibilities?"}]},{"@type":"WebSite","@id":"https:\/\/www.bplussolutions.com\/#website","url":"https:\/\/www.bplussolutions.com\/","name":"B+ SOLUTIONS","description":"Smart Medical Device Solutions - Trusted Partnership","publisher":{"@id":"https:\/\/www.bplussolutions.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.bplussolutions.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"tr"},{"@type":"Organization","@id":"https:\/\/www.bplussolutions.com\/#organization","name":"B+ SOLUTIONS","url":"https:\/\/www.bplussolutions.com\/","logo":{"@type":"ImageObject","inLanguage":"tr","@id":"https:\/\/www.bplussolutions.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.bplussolutions.com\/wp-content\/uploads\/2024\/10\/bplus-logo-2.png","contentUrl":"https:\/\/www.bplussolutions.com\/wp-content\/uploads\/2024\/10\/bplus-logo-2.png","width":1311,"height":98,"caption":"B+ SOLUTIONS"},"image":{"@id":"https:\/\/www.bplussolutions.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.bplussolutions.com\/#\/schema\/person\/ad19ba15a95e65cf6e772ccd66fb5c95","name":"beliz-admin","image":{"@type":"ImageObject","inLanguage":"tr","@id":"https:\/\/www.bplussolutions.com\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/653276de7314b473c5b0336ef151e31893f3504ad49df44f9014faf2b899d924?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/653276de7314b473c5b0336ef151e31893f3504ad49df44f9014faf2b899d924?s=96&d=mm&r=g","caption":"beliz-admin"},"url":"https:\/\/www.bplussolutions.com\/tr\/author\/beliz-admin\/"}]}},"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/posts\/662","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/comments?post=662"}],"version-history":[{"count":8,"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/posts\/662\/revisions"}],"predecessor-version":[{"id":800,"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/posts\/662\/revisions\/800"}],"wp:attachment":[{"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/media?parent=662"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/categories?post=662"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bplussolutions.com\/tr\/wp-json\/wp\/v2\/tags?post=662"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}