{"id":9279,"date":"2026-04-08T15:18:20","date_gmt":"2026-04-08T13:18:20","guid":{"rendered":"https:\/\/trigas-trigas-kunden.digitalspital.de\/nicht-kategorisiert\/notified-bodies-briefly-explained\/"},"modified":"2026-06-11T15:47:18","modified_gmt":"2026-06-11T13:47:18","slug":"notified-bodies","status":"publish","type":"post","link":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/notified-bodies\/","title":{"rendered":"Notified Bodies briefly explained"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9279\" class=\"elementor elementor-9279 elementor-4607\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc7b1de e-flex e-con-boxed e-con e-parent\" data-id=\"dc7b1de\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-16c2d3e elementor-widget elementor-widget-image\" data-id=\"16c2d3e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"370\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-benannte-stellen_1920x1080-V3-1-1024x473.webp\" class=\"attachment-large size-large wp-image-9294\" alt=\"Abstract blue background featuring three curved, darker blue stripes arching from the lower right corner toward the upper right, set against a gradient of deep blue tones\u2014symbolizing the structured paths often navigated by notified bodies.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-benannte-stellen_1920x1080-V3-1-1024x473.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-benannte-stellen_1920x1080-V3-1-300x138.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-benannte-stellen_1920x1080-V3-1-768x354.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-benannte-stellen_1920x1080-V3-1-1536x709.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-benannte-stellen_1920x1080-V3-1-2048x945.webp 2048w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e7bb5e elementor-widget elementor-widget-spacer\" data-id=\"8e7bb5e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f01bb0e elementor-widget elementor-widget-heading\" data-id=\"f01bb0e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What Are Notified Bodies and What Are Their Responsibilities?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27f8be4 elementor-widget elementor-widget-text-editor\" data-id=\"27f8be4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Notified Bodies are <strong>independent organisations officially designated by EU member states to carry out specific tasks related to the assessment and certification of products in the EU<\/strong>. For medical devices and in vitro diagnostics (IVDs), they assess whether the requirements of Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) are met &#8211; a prerequisite for CE marking and EU market access. Core activities include:<\/p><ul><li>Conformity assessment and certification under the MDR\/IVDR<\/li><li>Review of the technical documentation<\/li><li>Auditing of the quality management system<\/li><li>Inspections and surveillance, including unannounced audits<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e04d32c elementor-widget elementor-widget-text-editor\" data-id=\"e04d32c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><em><strong>Note:<\/strong> Notified Bodies are not regulatory authorities and do not provide technical or regulatory advice.<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ac41f9 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"6ac41f9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec6b28d elementor-widget elementor-widget-heading\" data-id=\"ec6b28d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">When Do Medical Devices and IVDs Need a Notified Body? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-afe88be elementor-widget elementor-widget-text-editor\" data-id=\"afe88be\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>A Notified Body is required for the following:<\/p><ul><li><p class=\"p1\">MDR: all classes except Class I<\/p><\/li><li><p class=\"p1\">IVDR: all classes except Class A non-sterile IVDs. Class A sterile and Class B, C, and D devices require a Notified Body. Without a successful conformity assessment procedure, neither CE marking nor market access can be obtained (for non-sterile Class A devices, the IVDR permits a manufacturer&#8217;s declaration of conformity; see IVDR Article 48(10)).<\/p><\/li><\/ul><p>Notified Bodies are therefore the key institutions for obtaining<strong> EU<\/strong> <strong>market access for a medical device or IVD<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1e62908 elementor-widget elementor-widget-spacer\" data-id=\"1e62908\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\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-377022e e-flex e-con-boxed e-con e-parent\" data-id=\"377022e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-adccd78 e-con-full e-flex e-con e-child\" data-id=\"adccd78\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-a5993d6 e-con-full e-flex e-con e-child\" data-id=\"a5993d6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-2759221 e-con-full e-flex e-con e-child\" data-id=\"2759221\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5523087 elementor-widget elementor-widget-heading\" data-id=\"5523087\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">We are happy to support you in your interactions with Notified Bodies. Contact us! <\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1349781 elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"1349781\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/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\">Get in touch<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-aeef55f e-con-full e-flex e-con e-child\" data-id=\"aeef55f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-3386159 e-con-full e-flex eael_liquid_glass-effect1 e-con e-child\" data-id=\"3386159\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6302864 elementor-widget elementor-widget-heading\" data-id=\"6302864\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\"><b>Dr. Stefanie Gaupp,<\/b> Team Lead Study Management<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\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-44bc32fd e-flex e-con-boxed e-con e-parent\" data-id=\"44bc32fd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-25b6343d elementor-widget elementor-widget-heading\" data-id=\"25b6343d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">You Might Also Be Interested In<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41bb5b86 elementor-widget elementor-widget-spacer\" data-id=\"41bb5b86\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9cc66d1 elementor-grid-3 elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"9cc66d1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:5310,&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_tablet&quot;:&quot;2&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-loop-container elementor-grid\" role=\"list\">\n\t\t<style id=\"loop-5310\">.elementor-5310 .elementor-element.elementor-element-945d7a9{--display:flex;--flex-direction:column;--container-widget-width:100%;--container-widget-height:initial;--container-widget-flex-grow:0;--container-widget-align-self:initial;--flex-wrap-mobile:wrap;--border-radius:20px 20px 20px 20px;box-shadow:0px 6px 38px 0px rgba(0, 0, 0, 0.23);--padding-top:0px;--padding-bottom:0px;--padding-left:0px;--padding-right:0px;}.elementor-5310 .elementor-element.elementor-element-945d7a9:not(.elementor-motion-effects-element-type-background), .elementor-5310 .elementor-element.elementor-element-945d7a9 > .elementor-motion-effects-container > .elementor-motion-effects-layer{background-color:var( --e-global-color-e232888 );}.elementor-widget-theme-post-featured-image .widget-image-caption{color:var( --e-global-color-text );font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight 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);}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );}}<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"5310\" class=\"elementor elementor-5310 e-loop-item e-loop-item-7617 post-7617 page type-page status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<div class=\"elementor-element elementor-element-945d7a9 e-flex e-con-boxed e-con e-parent\" data-id=\"945d7a9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6554424 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"6554424\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"480\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1024x614.webp\" class=\"attachment-large size-large wp-image-7619\" alt=\"A scientist wearing blue gloves and safety glasses examines samples on a slide through a microscope in a laboratory, conducting ivdr performance studies with scientific equipment visible in the background.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2.webp 2000w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37ab487 e-con-full e-flex e-con e-child\" data-id=\"37ab487\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45cfdc7 elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"45cfdc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tFrom study planning through execution to submission-ready reports: TRIGA-S supports you with specialised expertise, a modular service portfolio, and a dedicated point of contact.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e4d8fb elementor-widget elementor-widget-button\" data-id=\"8e4d8fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/diagnostics\/\" id=\"read-more-button\">\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\">Merh erfahren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\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>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"5310\" class=\"elementor elementor-5310 e-loop-item e-loop-item-7380 post-7380 page type-page status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<div class=\"elementor-element elementor-element-945d7a9 e-flex e-con-boxed e-con e-parent\" data-id=\"945d7a9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6554424 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"6554424\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"480\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1024x614.webp\" class=\"attachment-large size-large wp-image-7384\" alt=\"A scientist wearing safety goggles, gloves, and a lab coat stands in a laboratory specializing in pharma services, holding a piece of lab equipment and smiling at the camera. Shelves and lab supplies are visible in the background.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1.webp 2000w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37ab487 e-con-full e-flex e-con e-child\" data-id=\"37ab487\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45cfdc7 elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"45cfdc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tFrom exploratory R&amp;D analytics to submission-ready CDx validation: We support pharmaceutical companies with modular, IVDR-specialised services and dedicated points of contact.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e4d8fb elementor-widget elementor-widget-button\" data-id=\"8e4d8fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/pharma-services\/\" id=\"read-more-button\">\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\">Merh erfahren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\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>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"5310\" class=\"elementor elementor-5310 e-loop-item e-loop-item-8895 post-8895 post type-post status-publish format-standard has-post-thumbnail hentry category-cro-wiki\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<div class=\"elementor-element elementor-element-945d7a9 e-flex e-con-boxed e-con e-parent\" data-id=\"945d7a9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6554424 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"6554424\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"480\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-1024x614.webp\" class=\"attachment-large size-large wp-image-8896\" alt=\"Two people sit at a table with open laptops, one pointing at a screen while the other looks on, suggesting a collaborative work session focused on organizing the trial master file.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1.webp 2000w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37ab487 e-con-full e-flex e-con e-child\" data-id=\"37ab487\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45cfdc7 elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"45cfdc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tWhat is the TMF (Trial Master File) and why is it crucial for studies? Find out why it is considered the \u201cmemory\u201d of a study and which regulatory requirements it must meet.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e4d8fb elementor-widget elementor-widget-button\" data-id=\"8e4d8fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/trial-master-file\/\" id=\"read-more-button\">\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\">Merh erfahren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\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>\n\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-dd6cb82 e-flex e-con-boxed e-con e-parent\" data-id=\"dd6cb82\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-31dd286 e-con-full e-flex e-con e-child\" data-id=\"31dd286\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-614c1db elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"614c1db\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1020\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1020\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Abbreviations <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fontello fontelloarrow-up-right\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fontello fontelloarrow-down-right\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1020\" class=\"elementor-element elementor-element-3c25b4b e-con-full e-flex e-con e-child\" data-id=\"3c25b4b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0904a2c elementor-widget elementor-widget-text-editor\" data-id=\"0904a2c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>CE: European Conformity<\/p><p>EU: European Union<\/p><p>IVDs: In vitro diagnostics<\/p><p>IVDR: In Vitro Diagnostic Regulation<\/p><p>MDR: Medical Device Regulation<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\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>\n\t\t","protected":false},"excerpt":{"rendered":"<p>What are Notified Bodies? Learn about their role and responsibilities in the EU market access process for medical devices and IVDs.<\/p>\n","protected":false},"author":3,"featured_media":9292,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[25],"tags":[],"class_list":["post-9279","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cro-wiki"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Notified Bodies: Tasks and roles according to MDR and IVDR<\/title>\n<meta name=\"description\" content=\"Conformity assessment, testing, certification: Notified Bodies are central to EU market access for medical devices and IVDs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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