{"id":7676,"date":"2024-01-10T19:07:36","date_gmt":"2024-01-10T19:07:36","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7676"},"modified":"2024-01-12T20:11:36","modified_gmt":"2024-01-12T20:11:36","slug":"table-contents-eu-mdr-2017745","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/table-contents-eu-mdr-2017745\/","title":{"rendered":"Table of Contents for the EU MDR 2017\/745"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7676\" class=\"elementor elementor-7676\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/10\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 10, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Table of Contents for the EU MDR 2017\/745<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"824\" height=\"478\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/03\/Screenshot-2022-11-09-151149.png\" class=\"attachment-full size-full wp-image-5351\" alt=\"EU MDR TOC\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/03\/Screenshot-2022-11-09-151149.png 824w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/03\/Screenshot-2022-11-09-151149-300x174.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/03\/Screenshot-2022-11-09-151149-768x446.png 768w\" sizes=\"(max-width: 824px) 100vw, 824px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>If you have downloaded the 175-page European Medical Device Regulation PDF but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. We have taken the official MDR regulation as published on May 5, 2017 and added a very easy-to-navigate clickable MDR Table of Contents all in one single PDF.<\/p><p>\u00a0<\/p><h4><a href=\"http:\/\/ww2.orielstat.com\/rs\/231-KOL-532\/images\/EU-MDR-2017-745-Regulation-and-TOC.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">DOWNLOAD THE EU MDR TABLE OF CONTENTS<\/a><\/h4><p>\u00a0<\/p><p><strong>We&#8217;ve added internal links so you can quickly access every Chapter, Article, and Annex!<\/strong><\/p><p>\u00a0<\/p><p><span id=\"more-278\"><\/span>Inside the\u00a0<a href=\"http:\/\/ww2.orielstat.com\/rs\/231-KOL-532\/images\/EU-MDR-2017-745-Regulation-and-TOC.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Table of Contents for MDR 2017\/745<\/a>, you&#8217;ll find quick links to every significant section, including:<\/p><p>\u00a0<\/p><h5>CHAPTERS\/ARTICLES<\/h5><ul><li><strong>Chapter I, Articles 1-4<\/strong>\u00a0\u2013 Scope and definitions<\/li><li><strong>Chapter II, Articles 5-24<\/strong>\u00a0\u2013 Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement<\/li><li><strong>Chapter III, Articles 25-34<\/strong>\u00a0\u2013 Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices<\/li><li><strong>Chapter IV, Articles 35-50<\/strong>\u00a0\u2013 Notified bodies<\/li><li><strong>Chapter V, Articles 51-60<\/strong>\u00a0\u2013 Classification and conformity assessment<\/li><li><strong>Chapter VI, Articles 61-82<\/strong>\u00a0\u2013 Clinical evaluation and clinical investigations<\/li><li><strong>Chapter VII, Articles 83-100<\/strong>\u00a0\u2013 Post-market surveillance, vigilance and market surveillance<\/li><li><strong>Chapter VIII, Articles 101-108<\/strong>\u00a0\u2013 Cooperation between Member States, Medical Device Coordination Group, expert laboratories, expert panels and device registrars<\/li><li><strong>Chapter IX, Articles 109-113<\/strong>\u00a0\u2013 Confidentiality, data protection, funding and penalties<\/li><li><strong>Chapter X, Articles 114-123<\/strong>\u00a0\u2013 Final provisions<\/li><\/ul><h5>\u00a0<\/h5><h5>ANNEXES<\/h5><ul><li><strong>ANNEX I \u2013<\/strong>\u00a0General safety and performance requirements<\/li><li><strong>ANNEX II \u2013<\/strong>\u00a0Technical documentation<\/li><li><strong>ANNEX III \u2013<\/strong>\u00a0Technical documentation on post-market surveillance<\/li><li><strong>ANNEX IV \u2013<\/strong>\u00a0EU declaration of conformity<\/li><li><strong>ANNEX V \u2013<\/strong>\u00a0CE marking of conformity<\/li><li><strong>ANNEX VI \u2013<\/strong>\u00a0Registration of devices and economic operators; UDI<\/li><li><strong>ANNEX VII \u2013<\/strong>\u00a0Requirements to be met by notified bodies<\/li><li><strong>ANNEX VIII \u2013<\/strong>\u00a0Classification rules<\/li><li><strong>ANNEX IX \u2013<\/strong>\u00a0Conformity assessment based on a quality management system and on assessment of technical documentation<\/li><li><strong>ANNEX X \u2013<\/strong>\u00a0Conformity assessment based on type-examination<\/li><li><strong>ANNEX XI \u2013<\/strong>\u00a0Conformity assessment based on product conformity verification<\/li><li><strong>ANNEX XII \u2013<\/strong>\u00a0Certificates issued by a notified body<\/li><li><strong>ANNEX XIII \u2013<\/strong>\u00a0Procedure for custom-made devices<\/li><li><strong>ANNEX XIV \u2013<\/strong>\u00a0Clinical evaluation and post-market clinical follow-up<\/li><li><strong>ANNEX XV \u2013<\/strong>\u00a0Clinical investigations<\/li><li><strong>ANNEX XVI \u2013<\/strong>\u00a0List of groups of products without an intended medical purpose<\/li><li><strong>ANNEX XVII \u2013 <\/strong>Correlation table showing Council Directive 90\/385\/EEC, Council Directive 93\/42\/EEC and the MDR<\/li><\/ul><h3>\u00a0<\/h3><h3>Need help understanding what to do next?<\/h3><p>If you need help with MDR transition strategy, gap assessments, or simply getting up to speed quickly on the MDR requirements, check out our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/eu-mdr-training\">MDR training<\/a>\u00a0and\u00a0<a href=\"https:\/\/www.orielstat.com\/consulting\/New-EU-Medical-Device-Regulation\">consulting<\/a>\u00a0options. Oriel STAT A MATRIX has been assisting medical device companies with QA\/RA compliance for decades and we can help you smoothly transition to the MDR.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. Call<\/h6>\n    <\/div>\n    <div id=\"Bottom_icons1_DivOfficePhone\" class=\"row new_update_add\">\n<div class=\"col-lg-6 col-md-12 borderbottom\">\n <div class=\"block-text1\">\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/us-flag.jpg\">\n     <p>\n         <b>US Office<\/b>Washington DC<\/p>\n <\/div>\n <p>\n     <a href=\"tel:1.800.472.6477\">1.800.472.6477<\/a><\/p>\n<\/div>\n<div class=\"col-lg-6 col-md-12\">\n <div class=\"block-text1\">\n     <p>\n         <b>EU Office<\/b>Cork, Ireland<\/p>\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/eu-flag.jpg\" class=\"img-right-sec\">\n <\/div>\n <p>\n     <a href=\"tel:+353 21 212 8530\">+353 21 212 8530<\/a><\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element 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class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Table of Contents for the EU MDR 2017\/745 If you have downloaded the 175-page European Medical Device Regulation PDF but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. We have taken the official MDR regulation as published on May 5, 2017 and added [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5351,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[16],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/table-contents-eu-mdr-2017745\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Table of Contents for the EU MDR 2017\/745 If you have downloaded the 175-page European Medical Device Regulation PDF but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. 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