{"id":8333,"date":"2021-12-09T22:58:17","date_gmt":"2021-12-09T21:58:17","guid":{"rendered":"https:\/\/www.medicoforum.com\/mdr-certification\/"},"modified":"2024-05-20T00:14:36","modified_gmt":"2024-05-19T22:14:36","slug":"mdr-certification","status":"publish","type":"page","link":"https:\/\/www.medicoforum.com\/en\/mdr-certification\/","title":{"rendered":"MDR certification"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bd796f-d0fb62a1ca4db618da335498cbc17266\">\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.medicoforum.com\/wp-content\/uploads\/2020\/03\/layerformat_medicoforum_about_02.jpg);\nbackground-position:50% 0%;\nbackground-attachment:fixed;\nmargin-top:0px;\nmargin-bottom:60px;\n}\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266 .av-section-color-overlay{\nopacity:0.9;\n}\n#top 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class='scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello' data-av_svg_icon='down-open-mini' data-av_iconset='svg_entypo-fontello'><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewBox=\"0 0 15 32\" preserveAspectRatio=\"xMidYMid meet\" aria-labelledby='av-svg-title-1' aria-describedby='av-svg-desc-1' role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id='av-svg-title-1'>Scroll to next section<\/title>\n<desc id='av-svg-desc-1'>Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-8333'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-40055g-8e92745c085bfcaf3af486626a3347de av_one_third  avia-builder-el-1  el_before_av_two_third  avia-builder-el-first  first flex_column_div  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8tldev-7477fe854a43569da6a34da5169a9b8c\">\n.flex_column.av-8tldev-7477fe854a43569da6a34da5169a9b8c{\nborder-radius:0 21px 21px 21px;\npadding:34px 34px 34px 34px;\n}\n<\/style>\n<div  class='flex_column av-8tldev-7477fe854a43569da6a34da5169a9b8c av_two_third  avia-builder-el-2  el_after_av_one_third  avia-builder-el-last  whiteleft flex_column_div  '     ><section  class='av_textblock_section av-ldt3vqtv-c47ed971fec962019af6710018a0e499 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h1><span class=\"clbold\">MDR Certification:<br \/>\n<\/span>The path to approval for your medical devices.<\/h1>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4wb7k7-6e210fbbd59127907a22efbb79467c19\">\n#top .hr.av-4wb7k7-6e210fbbd59127907a22efbb79467c19{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-4wb7k7-6e210fbbd59127907a22efbb79467c19 .hr-inner{\nwidth:50px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-4wb7k7-6e210fbbd59127907a22efbb79467c19 hr-custom  avia-builder-el-4  el_after_av_textblock  el_before_av_iconlist  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-icon-list-container av-lvs44aaq-a18b7816b96ac9d82df5fac69255e0f9  avia-builder-el-5  el_after_av_hr  el_before_av_button  boxtype02'><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-small av-lvs44aaq-a18b7816b96ac9d82df5fac69255e0f9'>\n<li><div class='iconlist_icon av-lvs43864-6cf3f43350cea26f4b3369d04fc2b73f avia-font-medicoforum_icon avia-iconfont avia-font-medicoforum_icon'><span class='av-icon-char' data-av_icon='\ue900' data-av_iconfont='medicoforum_icon' aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Our services for MDR certification include:\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Our services for MDR certification include:<\/div><\/header><div class='iconlist_content '  itemprop=\"text\" ><ul class=\"medico-list-checked\">\n<li>Advice on the requirements of the MDR and the necessary steps for certification<\/li>\n<li>Support in the preparation of technical documentation in accordance with the MDR<\/li>\n<li>Support throughout the entire certification process<\/li>\n<li>Preparation and review of the clinical evaluation and the clinical evaluation report<\/li>\n<li>Preparation of the PMCF assessment report and its updating<\/li>\n<li>Support in the preparation of the risk analysis and the quality management system<\/li>\n<li>Implementation of audits<\/li>\n<li>Submission of the certification application to the Notified Body<\/li>\n<li>Support for the certification process with a notified body<\/li>\n<li>Support with registration in EUDAMED<\/li>\n<li>Advice on Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)<\/li>\n<li>Assistance with changes and extensions to existing certificates<\/li>\n<\/ul>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><br \/>\n<div  class='avia-button-wrap av-23xv9w-c5cb921fe7c48c448f0d84071ae6c84b-wrap avia-button-center  avia-builder-el-6  el_after_av_iconlist  el_before_av_hr  diamond'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-23xv9w-c5cb921fe7c48c448f0d84071ae6c84b\">\n#top #wrap_all .avia-button.av-23xv9w-c5cb921fe7c48c448f0d84071ae6c84b{\nbackground-color:#edf5f9;\nborder-color:#edf5f9;\ncolor:#666666;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-23xv9w-c5cb921fe7c48c448f0d84071ae6c84b .avia-svg-icon svg:first-child{\nfill:#666666;\nstroke:#666666;\n}\n<\/style>\n<a href='#contactform'  class='avia-button av-23xv9w-c5cb921fe7c48c448f0d84071ae6c84b av-link-btn avia-icon_select-yes-left-icon avia-size-x-large avia-position-center'   aria-label=\"Get in touch now\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-medicoforum_icon' data-av_icon='\ue900' data-av_iconfont='medicoforum_icon' ><\/span><span class='avia_iconbox_title' >Get in touch now<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lduj7ju5-8eec2b88b5ef4aa4a311e5883958f02b\">\n#top .hr.av-lduj7ju5-8eec2b88b5ef4aa4a311e5883958f02b{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-lduj7ju5-8eec2b88b5ef4aa4a311e5883958f02b .hr-inner{\nwidth:50px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-lduj7ju5-8eec2b88b5ef4aa4a311e5883958f02b hr-custom  avia-builder-el-7  el_after_av_button  el_before_av_heading  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-none'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-e4uys-e48f490a55ead13b6a254eb9d57fec78\">\n#top .av-special-heading.av-e4uys-e48f490a55ead13b6a254eb9d57fec78{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-e4uys-e48f490a55ead13b6a254eb9d57fec78 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-e4uys-e48f490a55ead13b6a254eb9d57fec78 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-e4uys-e48f490a55ead13b6a254eb9d57fec78 av-special-heading-h2  avia-builder-el-8  el_after_av_hr  el_before_av_toggle_container  av-thin-font'><h2 class='av-special-heading-tag '  itemprop=\"headline\"  ><strong>FAQ<\/strong> &#8211; frequently asked questions<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lwe39p9m-bd1544b86b3f63ba1761fdd76892590c\">\n#top .togglecontainer.av-lwe39p9m-bd1544b86b3f63ba1761fdd76892590c p.toggler{\ncolor:#005499;\n}\n#top .togglecontainer.av-lwe39p9m-bd1544b86b3f63ba1761fdd76892590c p.toggler .toggle_icon{\ncolor:#005499;\nborder-color:#005499;\n}\n#top .togglecontainer.av-lwe39p9m-bd1544b86b3f63ba1761fdd76892590c .toggle_wrap .toggle_content{\ncolor:#005499;\n}\n<\/style>\n<div  class='togglecontainer av-lwe39p9m-bd1544b86b3f63ba1761fdd76892590c av-minimal-toggle  avia-builder-el-9  el_after_av_heading  el_before_av_hr  toggle_close_all'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/FAQPage\" >\n<section class='av_toggle_section av-lwe37vrp-6848d6c8a5be477838e72feb1026e4c7'  itemscope=\"itemscope\" itemprop=\"mainEntity\" itemtype=\"https:\/\/schema.org\/Question\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-1' data-fake-id='#toggle-id-1' class='toggler  av-title-above av-inherit-font-color hasCustomColor'  itemprop=\"name\"  role='tab' tabindex='0' aria-controls='toggle-id-1' data-slide-speed=\"200\" data-title=\"How does MDR certification differ from the authorisation of medicinal products?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: How does MDR certification differ from the authorisation of medicinal products?\" data-aria_expanded=\"Click to collapse: How does MDR certification differ from the authorisation of medicinal products?\">How does MDR certification differ from the authorisation of medicinal products?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-1' aria-labelledby='toggle-toggle-id-1' role='region' class='toggle_wrap  av-title-above'   itemscope=\"itemscope\" itemprop=\"acceptedAnswer\" itemtype=\"https:\/\/schema.org\/Answer\" ><div class='toggle_content invers-color av-inherit-font-color hasCustomColor'  itemprop=\"text\" ><h3>How does MDR certification differ from the authorisation of medicinal products?<\/h3>\n<p>In contrast to medicinal products, which are formally approved, the conformity assessment of medical devices is carried out by the (certified) manufacturer itself. They must prove that the product meets all the necessary requirements in order to receive a declaration of conformity and bear the CE mark.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-lwe38im3-7f10a2984596bcf5731cf46e56f29c7b'  itemscope=\"itemscope\" itemprop=\"mainEntity\" itemtype=\"https:\/\/schema.org\/Question\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-2' data-fake-id='#toggle-id-2' class='toggler  av-title-above av-inherit-font-color hasCustomColor'  itemprop=\"name\"  role='tab' tabindex='0' aria-controls='toggle-id-2' data-slide-speed=\"200\" data-title=\"What\u2019s Medicoforum\u2019s role regarding MDR certification?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: What\u2019s Medicoforum\u2019s role regarding MDR certification?\" data-aria_expanded=\"Click to collapse: What\u2019s Medicoforum\u2019s role regarding MDR certification?\">What\u2019s Medicoforum\u2019s role regarding MDR certification?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-2' aria-labelledby='toggle-toggle-id-2' role='region' class='toggle_wrap  av-title-above'   itemscope=\"itemscope\" itemprop=\"acceptedAnswer\" itemtype=\"https:\/\/schema.org\/Answer\" ><div class='toggle_content invers-color av-inherit-font-color hasCustomColor'  itemprop=\"text\" ><h3>What&#8217;s Medicoforum&#8217;s role regarding MDR certification?<\/h3>\n<p>Medicoforum provides medical device manufacturers with comprehensive support for MDR certification. We offer expertise and experience to accompany the entire conformity assessment process, including the establishment of a quality management system, the preparation of technical documentation including risk management and clinical and biological evaluations.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-lwe38im3-3-041c639f8965980ee2f79dae25dd53fe'  itemscope=\"itemscope\" itemprop=\"mainEntity\" itemtype=\"https:\/\/schema.org\/Question\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-3' data-fake-id='#toggle-id-3' class='toggler  av-title-above av-inherit-font-color hasCustomColor'  itemprop=\"name\"  role='tab' tabindex='0' aria-controls='toggle-id-3' data-slide-speed=\"200\" data-title=\"Why should I choose Medicoforum for MDR certification?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Why should I choose Medicoforum for MDR certification?\" data-aria_expanded=\"Click to collapse: Why should I choose Medicoforum for MDR certification?\">Why should I choose Medicoforum for MDR certification?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-3' aria-labelledby='toggle-toggle-id-3' role='region' class='toggle_wrap  av-title-above'   itemscope=\"itemscope\" itemprop=\"acceptedAnswer\" itemtype=\"https:\/\/schema.org\/Answer\" ><div class='toggle_content invers-color av-inherit-font-color hasCustomColor'  itemprop=\"text\" ><h3>Why should I choose Medicoforum for MDR certification?<\/h3>\n<p>Medicoforum has extensive experience and expertise in the field of MDR certification. We not only provide up-to-date information and practical support, but also guide you through the entire process to ensure that your medical devices meet the required standards and are marketable in the European Economic Area.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-lwe39g6y-a8c46a6f72e8f615acf8e1d8aee1c04e'  itemscope=\"itemscope\" itemprop=\"mainEntity\" itemtype=\"https:\/\/schema.org\/Question\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-4' data-fake-id='#toggle-id-4' class='toggler  av-title-above av-inherit-font-color hasCustomColor'  itemprop=\"name\"  role='tab' tabindex='0' aria-controls='toggle-id-4' data-slide-speed=\"200\" data-title=\"How can I get in touch with Medicoforum?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: How can I get in touch with Medicoforum?\" data-aria_expanded=\"Click to collapse: How can I get in touch with Medicoforum?\">How can I get in touch with Medicoforum?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-4' aria-labelledby='toggle-toggle-id-4' role='region' class='toggle_wrap  av-title-above'   itemscope=\"itemscope\" itemprop=\"acceptedAnswer\" itemtype=\"https:\/\/schema.org\/Answer\" ><div class='toggle_content invers-color av-inherit-font-color hasCustomColor'  itemprop=\"text\" ><h3>How can I get in touch with Medicoforum?<\/h3>\n<p>For an initial consultation and further information on MDR certification, you can contact our specialists directly. We are at your side with help and advice to pave the way for the successful certification of your medical devices. Please use the contact form at the bottom of this page, send us an e-mail or give us a call!<\/p>\n<\/div><\/div><\/div><\/section>\n<\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005\">\n#top .hr.hr-invisible.av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005 hr-invisible  avia-builder-el-10  el_after_av_toggle_container  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-k7ooakmw-613eaad5cb9fbc26042fa1e57faaf447 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock strongblack'  itemprop=\"text\" ><h3>New MDR certification requirements since 2021<\/h3>\n<p>The Medical Device Regulation (EU) 2017\/745 (MDR) has served as the legal basis for MDR certification of medical devices throughout the EU since May 26, 2021; it is binding in all EU member states and does not need to be transposed into national law. In addition, there are national legislations in each member state, which can sometimes make marketability difficult.<\/p>\n<h3>We accompany you during your MDR certification<\/h3>\n<p>It should be noted at the outset that medical devices are not approved in the formal legal sense, as is the case with medicinal products, but are generally assessed for conformity by the certified medical device manufacturer itself. For this, the manufacturer must have gone through MDR certification, which we can assist you in achieving.<\/p>\n<h2>How we can help you with <span class=\"clbold\">MDR certification<\/span>:<\/h2>\n<p>For medical devices there are essential safety and performance requirements which must be met in a conformity assessment procedure. These regulations serve to ensure the safety of a product.<\/p>\n<p>To this end, the manufacturer must establish a quality management system that, for example, performs risk management and clinical evaluations for each product.<\/p>\n<h3>MDR risk class classification<\/h3>\n<p>The risk class of the medical device is decisive for the degree of personal responsibility of the manufacturer. Within the scope of certification, the MDR distinguishes between four risk classes, which classify medical devices be means of defined criteria.<\/p>\n<p><span class=\"clbold\">Risk class I:<br \/>\n<\/span> The lowest risk class 1 allows the manufacturer to take complete responsibility of the testing and certification process. Within the scope of certification, the MDR distinguishes between four risk classes, which classify medical devices by means of defined criteria.<\/p>\n<p><span class=\"clbold\">Risk classes IIa, IIb and III:<\/span><br \/>\nIn the case of higher risk classes, a private-law and independent testing and certification body (notified body) must be involved in the medical device approval process. This, in turn, is subject to a European-organized, state designation procedure and the observation of the competent authority. The Notified Body is responsible for carrying out the prescribed tests and issuing the corresponding certificates.<\/p>\n<p><strong>Do you have questions about the classification of your product?<br \/>\nTalk to our specialists about an initial classification.<\/strong><\/p>\n<h3>Every medical device must undergo the prescribed conformity procedure.<\/h3>\n<p>If a medical device meets all the necessary performance and safety requirements and can demonstrate the acceptability of the risk-benefit ratio, this is documented in a declaration of conformity and given the CE mark, which makes it freely marketable throughout the European Economic Area.<\/p>\n<p>Post-marketing vigilance systems (continuous monitoring) are in place that can identify risks and allow further monitoring of the products.<\/p>\n<h3>How Medicoforum supports you<\/h3>\n<p><strong>Medicoforum is experienced in achieving and maintaining marketability. We help you with advice and action as well as keeping you up to date with the latest information, so that you can continue to develop your product. We can also use our experience and expertise to support you during the approval process of your medical devices or MDR certification procedure.<\/strong><\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-38ewz8-de77987cc419368b996253853efd3283\">\n#top .hr.hr-invisible.av-38ewz8-de77987cc419368b996253853efd3283{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-38ewz8-de77987cc419368b996253853efd3283 hr-invisible  avia-builder-el-12  el_after_av_textblock  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>[av_section min_height='percent' min_height_pc='77' min_height_px='500px' shadow='no-border-styling' bottom_border='border-extra-arrow-down' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' padding='large' margin='aviaTBmargin' custom_margin='0px,60px' av-desktop-custom_margin='' 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id='' custom_class='' template_class='' av_uid='av-2tkxoc' sc_version='1.0' admin_preview_bg='']\n\n[av_textblock fold_type='' fold_height='' fold_more='Weiterlesen' fold_less='Read less' fold_text_style='' fold_btn_align='' textblock_styling_align='' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' fold_overlay_color='' fold_text_color='' fold_btn_color='theme-color' fold_btn_bg_color='' fold_btn_font_color='' size-btn-text='' av-desktop-font-size-btn-text='' av-medium-font-size-btn-text='' av-small-font-size-btn-text='' av-mini-font-size-btn-text='' fold_timer='' z_index_fold='' id='' custom_class='' template_class='' av_uid='av-ks0k1swi' sc_version='1.0' admin_preview_bg='']\n<span class=\"clbold\">Our focus:<\/span> MDR consulting and services for medical devices such as quality management, risk management, clinical data and studies or 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