{"id":5409,"date":"2020-11-02T08:16:44","date_gmt":"2020-11-02T07:16:44","guid":{"rendered":"https:\/\/mec-abc.de\/whitepaper-requirements-under-mdr\/"},"modified":"2026-02-18T12:20:54","modified_gmt":"2026-02-18T11:20:54","slug":"whitepaper-requirements-under-mdr","status":"publish","type":"page","link":"https:\/\/mec-abc.de\/en\/whitepaper-requirements-under-mdr\/","title":{"rendered":"Whitepaper &#8211; Requirements under MDR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5409\" class=\"elementor elementor-5409 elementor-3767\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-540305d6 e-flex e-con-boxed e-con e-parent\" data-id=\"540305d6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5dc35b59 e-con-full e-flex e-con e-child\" data-id=\"5dc35b59\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-70fdf010 elementor-widget elementor-widget-image\" data-id=\"70fdf010\" 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=\"512\" height=\"512\" src=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512.png\" class=\"attachment-full size-full wp-image-5291\" alt=\"\" srcset=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512.png 512w, https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512-300x300.png 300w, https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512-100x100.png 100w, https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512-150x150.png 150w\" sizes=\"(max-width: 512px) 100vw, 512px\" \/>\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<div class=\"elementor-element elementor-element-61144189 e-con-full e-flex e-con e-child\" data-id=\"61144189\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4854946f elementor-widget elementor-widget-heading\" data-id=\"4854946f\" 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\">Whitepaper<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d115352 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3d115352\" 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-8c04068 elementor-widget elementor-widget-heading\" data-id=\"8c04068\" 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\">Publications<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c7dd97c elementor-widget elementor-widget-text-editor\" data-id=\"5c7dd97c\" 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 _msttexthash=\"28950506\" _msthash=\"20677\">Since May 26, 2021, the Medical Device Regulation (MDR) has been mandatory for all manufacturers. <br>Our whitepaper delivers the essential background information you need to know. It is completely free and ready to apply to your projects.<\/p>\n<p _msthidden=\"1\"><strong _msttexthash=\"663533\" _msthash=\"20676\">Download now and get MDR-ready!<\/strong><\/p>\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<div class=\"elementor-element elementor-element-3be588cf e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"3be588cf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[],&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-909451e elementor-widget elementor-widget-text-editor\" data-id=\"909451e\" 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>Take the challenge actively into your own hands. We are happy to support you by building up expertise, writing clinical approval documents, providing support as a remote team and\/or PRRC (person responsible for regulatory compliance in accordance with Art. 15 MDR).<\/p>\t\t\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-5835842e e-flex e-con-boxed e-con e-parent\" data-id=\"5835842e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;_id&quot;:&quot;f1b1759&quot;,&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:&quot;1&quot;,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4c6ff660 e-con-full e-flex e-con e-child\" data-id=\"4c6ff660\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4faf1ab6 elementor-widget elementor-widget-heading\" data-id=\"4faf1ab6\" 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\">Free Whitepapers<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-404d2e0d elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"404d2e0d\" 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>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7289176 e-grid e-con-boxed e-con e-parent\" data-id=\"7289176\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-cfc7493 e-con-full e-flex e-con e-child\" data-id=\"cfc7493\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4c96733 elementor-widget elementor-widget-heading\" data-id=\"4c96733\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><font>MDR Requirements Overview: Clinical Evaluation focused<\/font><font><\/font><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7ffb6c elementor-widget elementor-widget-text-editor\" data-id=\"d7ffb6c\" 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>Everything essential about MDR 2017\/745 \u2013 with emphasis on clinical evaluation of medical devices. Find all the key requirements you need for certification and audits and get MDR ready.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b53da87 elementor-widget elementor-widget-button\" data-id=\"b53da87\" 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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6OTUzMCwidG9nZ2xlIjpmYWxzZX0%3D\">\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\">Download Whitepaper now!<\/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<div class=\"elementor-element elementor-element-b5f4406 e-flex e-con-boxed e-con e-child\" data-id=\"b5f4406\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e668825 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e668825\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Conformity Assessment Procedures Explained<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-80ed639 elementor-widget elementor-widget-text-editor\" data-id=\"80ed639\" 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>Clear overview of all MDR procedures for medical devices. Which procedure applies to your product? Find all essential steps and requirements at a glance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e3850cc elementor-widget elementor-widget-button\" data-id=\"e3850cc\" 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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6OTUzNywidG9nZ2xlIjpmYWxzZX0%3D\">\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\">Download Whitepaper now!<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-276e7ba e-con-full e-flex e-con e-child\" data-id=\"276e7ba\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0ad2453 elementor-widget elementor-widget-heading\" data-id=\"0ad2453\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Guide for preparation of Clinical Evaluation under MDR<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-273abeb elementor-widget elementor-widget-text-editor\" data-id=\"273abeb\" 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>Practical handbook for creating MDR-compliant clinical evaluations. Step-by-step guide from scoping and data analysis to CER. Find everything you need for successful certification.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ae2ad01 elementor-widget elementor-widget-button\" data-id=\"ae2ad01\" 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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6OTUyMywidG9nZ2xlIjpmYWxzZX0%3D\">\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\">Download Whitepaper now!<\/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","protected":false},"excerpt":{"rendered":"<p>Whitepaper Publications Since May 26, 2021, the Medical Device Regulation (MDR) has been mandatory for all manufacturers. Our whitepaper delivers the essential background information you need to know. It is completely free and ready to apply to your projects. Download now and get MDR-ready! Take the challenge actively into your own hands. We are happy [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-5409","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5409","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/comments?post=5409"}],"version-history":[{"count":6,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5409\/revisions"}],"predecessor-version":[{"id":9656,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5409\/revisions\/9656"}],"wp:attachment":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/media?parent=5409"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}