{"id":8380,"date":"2024-05-14T12:49:13","date_gmt":"2024-05-14T10:49:13","guid":{"rendered":"https:\/\/mec-abc.de\/klinische-daten-in-der-mdr\/"},"modified":"2026-02-12T14:25:30","modified_gmt":"2026-02-12T13:25:30","slug":"clinical-data","status":"publish","type":"page","link":"https:\/\/mec-abc.de\/en\/business-services\/consulting\/clinical-data\/","title":{"rendered":"Clinical Data is the New Currency of the MDR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"8380\" class=\"elementor elementor-8380 elementor-7244\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1def6cd e-flex e-con-boxed e-con e-parent\" data-id=\"1def6cd\" 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-14b158e e-flex e-con-boxed e-con e-child\" data-id=\"14b158e\" 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-83a26c6 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"83a26c6\" 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\">Clinical Data is the New Currency of the MDR<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-458d4e6 elementor-widget elementor-widget-text-editor\" data-id=\"458d4e6\" 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><strong>To ensure that your existing products receive MDR certification and can remain on the market, you need clinical data, but you don\u2019t know which ones?<\/strong><\/p><p>The Notified Body has already notified that you need clinical data, but you don\u2019t know where to start?<\/p><p>The clinical evaluation of your existing product did not pass the certification, and the deficiency report does not give you clear answers on how to proceed?<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e906cb5 elementor-widget elementor-widget-heading\" data-id=\"e906cb5\" 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\">With us you:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f94ed4e elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"f94ed4e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Save money by checking if clinical studies are necessary.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Achieve faster certification through fewer corrections.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Get \"Sustainable\" - comprehensive, consistent - better concept and less vulnerable with auditor change.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Reduce restlessness and have less stress in the organization due to a clear line of action in the process.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Get higher safety through a comprehensive strategy and approach.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\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-aa91cc0 e-flex e-con-boxed e-con e-child\" data-id=\"aa91cc0\" data-element_type=\"container\" data-e-type=\"container\" id=\"consulting\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&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-9c111a9 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"9c111a9\" 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\">Book a free initial consultation<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b2356b elementor-widget elementor-widget-text-editor\" data-id=\"9b2356b\" 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><strong>Book a free consultation with our experts now.<\/strong><\/p><p>Within 30 minutes, the aim is to discuss your current situation and develop a roadmap for implementing your admission project.<\/p><p>Get to what is crowned with success: Comprehensive Admission Strategy &amp; Operational Implementation.<\/p><p><strong>Make your appointment right here.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8dfefc0 elementor-widget elementor-widget-button\" data-id=\"8dfefc0\" 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:\/\/outlook.office.com\/bookwithme\/user\/507600a3044b4783a72bc45af1b0a858%40mec-abc.de?anonymous&#038;ismsaljsauthenabled=true\" target=\"_blank\" rel=\"nofollow\">\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\">BOOK YOUR APPOINTMENT HERE<\/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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-60c638b e-flex e-con-boxed e-con e-parent\" data-id=\"60c638b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[],&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5d58fa1a elementor-widget elementor-widget-heading\" data-id=\"5d58fa1a\" 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\">Our Approach<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12db6bf elementor-widget elementor-widget-n-accordion\" data-id=\"12db6bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&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-1970\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-1970\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 1. Quick Check Initial Situation <\/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' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/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-1970\" class=\"elementor-element elementor-element-175b403 e-con-full e-flex e-con e-child\" data-id=\"175b403\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1970\" class=\"elementor-element elementor-element-5d8c5263 e-con-full e-flex e-con e-child\" data-id=\"5d8c5263\" 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-14f7bbd4 elementor-widget elementor-widget-heading\" data-id=\"14f7bbd4\" 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\">1. Quick Check Initial Situation<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-63f8722c elementor-widget elementor-widget-text-editor\" data-id=\"63f8722c\" 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><strong>Basic clinical data:<\/strong> At the beginning of the consultation, we take the time to understand your company and your products precisely. We clarify your individual requirements and goals to prepare a tailor-made strategy. If there is a deficiency report from a notified body, it will be thoroughly analyzed.<\/p><p>Your existing clinical master data, including intended purpose, indications, patient groups, and clinical benefit information, are examined for MDR suitability. We identify potential gaps and inconsistencies that may stand in the way of MDR compliance.<\/p><p>Based on our findings, we present you with clear and practice-oriented recommendations. These include necessary adjustments to enable certification according to MDR.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1970\" class=\"elementor-element elementor-element-45d0e4a5 e-con-full e-flex e-con e-child\" data-id=\"45d0e4a5\" 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-21b44ce9 elementor-widget elementor-widget-heading\" data-id=\"21b44ce9\" 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\">Result<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a4e424a elementor-widget elementor-widget-text-editor\" data-id=\"2a4e424a\" 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><strong>Knowledge:<\/strong><\/p><p>You know whether the intended purpose, indications, target patient groups, and clinical benefit information are suitable for MDR certification.<\/p><p><strong>Cost Reduction:<\/strong><\/p><ul><li>Prevention of ambiguous formulations of master data.<\/li><li>Avoidance of certification problems that are independent of the clinical data situation.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1971\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1971\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2. Clinical Data Analysis <\/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' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/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-1971\" class=\"elementor-element elementor-element-57e516a e-con-full e-flex e-con e-child\" data-id=\"57e516a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1971\" class=\"elementor-element elementor-element-4a8b291c e-con-full e-flex e-con e-child\" data-id=\"4a8b291c\" 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-7302d456 elementor-widget elementor-widget-heading\" data-id=\"7302d456\" 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\">2. Clinical Data Analysis<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7c99e1 elementor-widget elementor-widget-text-editor\" data-id=\"1f7c99e1\" 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>We start with a thorough data collection, where we identify your existing clinical data. This can include clinical studies, patient data, test results, and other relevant information.<\/p><p>Our team analyzes the collected data for its relevance to the clinical master data. The extracted information is then carefully assigned to the corresponding clinical master data. We evaluate the data regarding its quality and evidence base to ensure that the master data is significant and correct.<\/p><p>After completing the analysis, we present our findings and recommendations to you. Together we evaluate whether some master data may possibly be removed from the certification of your medical device if they are not sufficiently supported by the clinical data.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1971\" class=\"elementor-element elementor-element-5e29ea56 e-con-full e-flex e-con e-child\" data-id=\"5e29ea56\" 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-6b845de5 elementor-widget elementor-widget-heading\" data-id=\"6b845de5\" 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\">Result<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62d79581 elementor-widget elementor-widget-text-editor\" data-id=\"62d79581\" 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><strong>Cost reduction: <\/strong><\/p><ul><li>You recognize which master data have insufficient clinical data.<\/li><li>You make informed decisions about which aspects need to be changed.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1972\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1972\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 3. Benchmarking <\/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' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/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-1972\" class=\"elementor-element elementor-element-187090f e-con-full e-flex e-con e-child\" data-id=\"187090f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1972\" class=\"elementor-element elementor-element-4925ed3a e-con-full e-flex e-con e-child\" data-id=\"4925ed3a\" 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-6d91f8a2 elementor-widget elementor-widget-heading\" data-id=\"6d91f8a2\" 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\">3. Benchmarking<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1a10cb63 elementor-widget elementor-widget-text-editor\" data-id=\"1a10cb63\" 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>Our experts thoroughly research the state of the art concerning medical devices and identify the treatment standard in the field of use of your medical device, and alternative treatment options. We collect and evaluate relevant literature to create a solid foundation for our analysis.<\/p><p>Derivation of clinical endpoints: By evaluating the collected data, we derive meaningful clinical endpoints that serve as objective standards for safety and performance of your medical device.<\/p><p>Setting benchmarks: In addition to the clinical endpoints, we identify benchmarks and reference values. These benchmarks form the basis for the quantitative evaluation of the clinical data to prove the safety and performance of your medical device. This gives you a well-founded comparison and an objective evaluation of the results.<\/p><p>So that you can be sure that your medical device can withstand all critical examinations of the Notified Bodies in the clinical area, you will receive a quantitative analysis of your clinical data compared to the state of the art. With this, you get a fact-based analysis that explains which data is sufficient and which data needs to be collected in the PMCF.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1972\" class=\"elementor-element elementor-element-449a04b1 e-con-full e-flex e-con e-child\" data-id=\"449a04b1\" 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-76f9b263 elementor-widget elementor-widget-heading\" data-id=\"76f9b263\" 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\">Result<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-686fd7e7 elementor-widget elementor-widget-text-editor\" data-id=\"686fd7e7\" 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><strong>Clarity:<\/strong><\/p><p>You know which clinical data must be gathered in the PMCF and how they must be collected, including the clinical endpoints and parameters.<\/p><p><strong>Cost Reduction:<\/strong><\/p><ul><li>You don\u2019t spend money on unnecessary studies.<\/li><li>You conduct targeted studies.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1973\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1973\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 4. Collecting Clinical Data <\/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' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/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-1973\" class=\"elementor-element elementor-element-33fa91b e-con-full e-flex e-con e-child\" data-id=\"33fa91b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1973\" class=\"elementor-element elementor-element-5141ab9f e-con-full e-flex e-con e-child\" data-id=\"5141ab9f\" 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-2b219da3 elementor-widget elementor-widget-heading\" data-id=\"2b219da3\" 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\">4. Collecting Clinical Data<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1253bddd elementor-widget elementor-widget-text-editor\" data-id=\"1253bddd\" 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>Existing data gaps are closed by efficiently planning PMCF activities such as clinical studies. We rely on an extensive partner network to support you as best as possible.<\/p><p>The first step is always to create a data collection\/study plan. The aim is not only to collect the right data but also to collect it efficiently \u2013 so that the data collection fits the processes in the clinics and practices and avoids unnecessary additional work for the medical and nursing staff.<\/p><p>As a result, you get a targeted synopsis with which you can further pursue the operational study implementation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1973\" class=\"elementor-element elementor-element-3fb2d3cf e-con-full e-flex e-con e-child\" data-id=\"3fb2d3cf\" 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-6519247c elementor-widget elementor-widget-heading\" data-id=\"6519247c\" 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\">Result<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18682282 elementor-widget elementor-widget-text-editor\" data-id=\"18682282\" 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><strong>Cost Reduction:<\/strong><\/p><p>Efficient study planning based on the actual processes in the clinic\/practice.<\/p><p><strong>Time Efficiency:<\/strong><\/p><ul><li>Clear processes in the study lead to a quick collection of data.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1974\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1974\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 5. Certification with Clinical Evaluation According to MDR <\/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' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/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-1974\" class=\"elementor-element elementor-element-d54a579 e-con-full e-flex e-con e-child\" data-id=\"d54a579\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1974\" class=\"elementor-element elementor-element-1139c8e0 e-con-full e-flex e-con e-child\" data-id=\"1139c8e0\" 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-7c642b elementor-widget elementor-widget-heading\" data-id=\"7c642b\" 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\">5. Certification with Clinical Evaluation According to MDR<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25b1f734 elementor-widget elementor-widget-text-editor\" data-id=\"25b1f734\" 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>All previous research can be used for the creation and revision of the clinical evaluation according to MDR. The documentation of the research is done according to MEDDEV 2.7.1. Rev. 4 and MDR.<\/p><p>Thus, from the clinical evaluation perspective, nothing stands in the way of the certification according to MDR!<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1974\" class=\"elementor-element elementor-element-2c440957 e-con-full e-flex e-con e-child\" data-id=\"2c440957\" 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-3b97f716 elementor-widget elementor-widget-heading\" data-id=\"3b97f716\" 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\">Result<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-191f3ae0 elementor-widget elementor-widget-text-editor\" data-id=\"191f3ae0\" 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><strong>Cost Reduction:<\/strong><\/p><p>All research can be used for clinical evaluation.<\/p><p><strong>Security:<\/strong><\/p><p>The Notified Bodies are presented with a clinical evaluation that demonstrates the safety and performance of your medical device based on quantitative criteria.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1bacf016 e-flex e-con-boxed e-con e-parent\" data-id=\"1bacf016\" 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-f92ceab elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f92ceab\" 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=\"#consulting\">\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 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 class=\"elementor-element elementor-element-2b097440 elementor-widget elementor-widget-image\" data-id=\"2b097440\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_rotateZ_effect&quot;:&quot;yes&quot;,&quot;motion_fx_rotateZ_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1,&quot;sizes&quot;:[]},&quot;motion_fx_rotateZ_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" 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=\"300\" height=\"300\" src=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512-300x300.png\" class=\"attachment-medium size-medium wp-image-5291\" alt=\"\" srcset=\"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, https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512.png 512w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\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-6d54f93a e-flex e-con-boxed e-con e-parent\" data-id=\"6d54f93a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&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-638013a5 e-flex e-con-boxed e-con e-child\" data-id=\"638013a5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&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-58450a17 elementor-widget elementor-widget-heading\" data-id=\"58450a17\" 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\">MEC-ABC Your guide to clinical data for the MDR<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-68a38d1a elementor-widget elementor-widget-text-editor\" data-id=\"68a38d1a\" 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>We support you in generating, collecting, and updating clinical data for the entire life cycle of your product. MEC-ABC acts as a guide, providing advice on understanding and correctly applying all regulatory requirements.<\/p><p>Our experts help you implement PMS\/PMCF processes and support you in carrying out PMS\/PMCF activities such as PMCF studies. In addition, we prepare all necessary documents (e.g., PMS plan, PMS report, PSUR, SSCP, PMCF plan, PMCF report).\u00e5<\/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\t\t<div class=\"elementor-element elementor-element-7ca323d elementor-align-center elementor-widget elementor-widget-button\" data-id=\"7ca323d\" 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=\"#consulting\">\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 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-1793b25 e-flex e-con-boxed e-con e-parent\" data-id=\"1793b25\" 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-c8e4238 elementor-widget elementor-widget-heading\" data-id=\"c8e4238\" 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\">Case Report<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-05dfbc9 elementor-widget elementor-widget-image\" data-id=\"05dfbc9\" 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\t<a href=\"https:\/\/mec-abc.de\/en\/case-report-dental-implant\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/2.png\" class=\"attachment-full size-full wp-image-6793\" alt=\"\" srcset=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/2.png 1080w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/2-300x300.png 300w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/2-1024x1024.png 1024w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/2-150x150.png 150w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/2-768x768.png 768w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/2-600x600.png 600w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/2-100x100.png 100w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Clinical Data is the New Currency of the MDR To ensure that your existing products receive MDR certification and can remain on the market, you need clinical data, but you don\u2019t know which ones? The Notified Body has already notified that you need clinical data, but you don\u2019t know where to start? The clinical evaluation [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":9384,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-8380","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/8380","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=8380"}],"version-history":[{"count":5,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/8380\/revisions"}],"predecessor-version":[{"id":9428,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/8380\/revisions\/9428"}],"up":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/9384"}],"wp:attachment":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/media?parent=8380"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}