{"id":47360,"date":"2026-11-01T19:51:23","date_gmt":"2026-11-01T22:51:23","guid":{"rendered":"https:\/\/sobelconsult.com\/home\/unsere-losungen-2\/europaische-union\/"},"modified":"2026-11-01T19:53:26","modified_gmt":"2026-11-01T22:53:26","slug":"europaische-union","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/europaische-union\/","title":{"rendered":"Europ\u00e4ische Union"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"47360\" class=\"elementor elementor-47360 elementor-47213\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3973c3f e-flex e-con-boxed e-con e-child\" data-id=\"3973c3f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a6224be elementor-widget elementor-widget-html\" data-id=\"a6224be\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbm\">\n<nav class=\"sbm-crumb sb-crumb\" aria-label=\"Breadcrumb\"><a href=\"\/\">Startseite<\/a><span aria-hidden=\"true\">\u203a<\/span><a href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/\">L\u00f6sungen<\/a><span aria-hidden=\"true\">\u203a<\/span><span aria-current=\"page\">Europ\u00e4ische Union<\/span><\/nav>\n<div class=\"sbm-grid\">\n<div class=\"sbm-txt\">\n<p class=\"sbm-eye\">Medizinprodukte \u00b7 Kosmetika<\/p>\n<h1 class=\"sbm-h1\">Ihr Zulassungsweg zur <span class=\"sbm-gold\">Europ\u00e4ischen Union<\/span>.<\/h1>\n<p class=\"sbm-lead\">Medizinprodukte unterliegen der MDR, Kosmetika der EU-Kosmetikverordnung. Wir bereiten Ihre Unterlagen vor und fungieren als Ihr in der EU ans\u00e4ssiger Bevollm\u00e4chtigter oder als Verantwortliche Person.<\/p>\n<div class=\"sbm-ctas\"><a class=\"sbm-btn\" href=\"#footer-cta\">Erstberatung buchen<\/a><a class=\"sbm-link\" href=\"#eu-products\">W\u00e4hlen Sie Ihr Produkt aus \u2192<\/a><\/div>\n<p class=\"sbm-trust\">Medizinprodukte \u00b7 Kosmetika \u00b7 ISO 9001-zertifiziert in Brasilien \u00b7 Service in PT \u00b7 EN \u00b7 DE<\/p>\n<\/div>\n<div class=\"sbm-photo\"><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-market-eu-brussels.png\" alt=\"Flaggen der Europ\u00e4ischen Union vor dem Berlaymont-Geb\u00e4ude in Br\u00fcssel zur goldenen Stunde\" width=\"1184\" height=\"896\" fetchpriority=\"high\"><\/div>\n<\/div>\n<\/div>\n<style>\n.sbm{font-family:'Host Grotesk',system-ui,sans-serif;color:#2B2E34;padding-top:17px}\n.sbm .sbm-crumb{display:flex;align-items:center;gap:8px;margin:0 0 32px;font-size:14px;line-height:20px;color:#4F535B;white-space:nowrap;min-width:0}\n.sbm .sbm-crumb a{color:#4F535B;text-decoration:none;font-weight:400;font-size:inherit;line-height:inherit;font-family:inherit}\n.sbm .sbm-crumb a:hover,.sbm .sbm-crumb a:focus{color:#051B5A;text-decoration:underline}\n.sbm .sbm-crumb [aria-current]{color:#051B5A;font-weight:600;overflow:hidden;text-overflow:ellipsis;min-width:0}\n.sbm-grid{display:flex;gap:48px;align-items:stretch}\n.sbm-txt{flex:1 1 55%;display:flex;flex-direction:column;min-width:0}\n.sbm .sbm-eye{display:flex;align-items:center;gap:10px;margin:0;font-size:13px;font-weight:600;letter-spacing:.16em;text-transform:uppercase;color:#051B5A;line-height:1.4}\n.sbm .sbm-eye:before{content:\"\";flex:0 0 9px;width:9px;height:9px;border-radius:50%;background:#F2B705}\n.sbm h1.sbm-h1{font-family:Lora,Georgia,serif;font-weight:700;font-size:50px;line-height:1.12;color:#051B5A;margin:22px 0 0;letter-spacing:0;text-transform:none}\n.sbm .sbm-gold{color:#F2B705}\n.sbm .sbm-lead{font-size:20px;line-height:1.55;color:#051B5A;margin:26px 0 0}\n.sbm-ctas{display:flex;flex-wrap:wrap;align-items:center;gap:24px;margin-top:32px}\n.sbm .sbm-btn{display:inline-flex;align-items:center;justify-content:center;min-height:52px;background:#F2B705;color:#3A2B00;font-weight:600;font-size:16px;line-height:1.3;padding:14px 28px;border-radius:999px;text-decoration:none;border:0;text-align:center}\n.sbm .sbm-btn:hover,.sbm .sbm-btn:focus{background:#E0A800;color:#3A2B00}\n.sbm .sbm-link{font-weight:600;font-size:18px;color:#051B5A;text-decoration:underline;text-decoration-color:#F2B705;text-underline-offset:4px}\n.sbm .sbm-link:hover,.sbm .sbm-link:focus{color:#051B5A;text-decoration-thickness:2px}\n.sbm .sbm-trust{font-size:14px;line-height:1.5;color:#4F535B;margin:36px 0 0}\n.sbm-photo{flex:0 1 45%;position:relative;min-height:320px;border-radius:22px;overflow:hidden;box-shadow:0 12px 32px rgba(7,31,99,.12)}\n.sbm-photo img{position:absolute;inset:0;width:100%!important;height:100%!important;max-width:none!important;object-fit:cover;object-position:50% 50%;border-radius:22px}\n@media (max-width:1024px){.sbm h1.sbm-h1{font-size:42px}.sbm-grid{gap:32px}}\n@media (min-width:1025px) and (max-height:840px){.sbm h1.sbm-h1{font-size:42px}.sbm .sbm-lead{margin-top:20px}.sbm-ctas{margin-top:28px}.sbm .sbm-trust{margin-top:28px}}\n@media (max-width:860px){.sbm-grid{flex-direction:column}.sbm-photo{flex-basis:auto;width:100%;min-height:0;height:300px}}\n@media (max-width:767px){.sbm{padding-top:0}.sbm .sbm-crumb{margin-bottom:20px;font-size:13px}.sbm-txt{text-align:center}.sbm-txt .sbm-eye{justify-content:center}.sbm h1.sbm-h1{font-size:32px;margin-top:16px}.sbm .sbm-lead{font-size:18px;margin-top:20px}.sbm-ctas{flex-direction:column;gap:12px;margin-top:24px}.sbm .sbm-btn{width:100%}.sbm .sbm-trust{margin-top:24px}.sbm-photo{height:240px}}\n<\/style>\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-43b7688 e-flex e-con-boxed e-con e-parent\" data-id=\"43b7688\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f78be9d e-con-full e-flex e-con e-child\" data-id=\"f78be9d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7cdaacd elementor-widget elementor-widget-heading\" data-id=\"7cdaacd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">WO SIE HERKOMMEN<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75e1abf elementor-widget elementor-widget-heading\" data-id=\"75e1abf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Zwei Ausgangspunkte, ein Markt<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-75ffb3a e-con-full e-flex e-con e-child\" data-id=\"75ffb3a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bff56ef e-con-full e-flex e-con e-child\" data-id=\"bff56ef\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0ba9d0f elementor-widget elementor-widget-heading\" data-id=\"0ba9d0f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Zum ersten Mal in der EU<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-abb103b elementor-widget elementor-widget-text-editor\" data-id=\"abb103b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Sie befinden sich au\u00dferhalb der Europ\u00e4ischen Union und m\u00f6chten Ihr Medizinprodukt oder Ihr Kosmetikprodukt auf dem EU-Markt in Verkehr bringen.<\/p><ul class=\"sb-li\" style=\"margin:12px 0 0;padding-left:18px;color:#2B2E34;line-height:1.7\"><li>Ihre MDR-Klasse und Ihr Konformit\u00e4tspfad sind festgelegt<\/li><li>Technische Dokumentation bereit f\u00fcr die Pr\u00fcfung durch eine Benannte Stelle, sofern erforderlich<\/li><li>Sobel als Ihr in der EU benannter Vertreter oder Verantwortlicher<\/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<div class=\"elementor-element elementor-element-678f419 e-con-full e-flex e-con e-child\" data-id=\"678f419\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eed8928 elementor-widget elementor-widget-heading\" data-id=\"eed8928\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Bereits in einem anderen Markt zugelassen<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7319913 elementor-widget elementor-widget-text-editor\" data-id=\"7319913\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Ihr Produkt ist bereits in Brasilien auf dem Markt, und nun ist Europa Ihr n\u00e4chster Schritt.<\/p><ul class=\"sb-li\" style=\"margin:12px 0 0;padding-left:18px;color:#2B2E34;line-height:1.7\"><li>Was l\u00e4sst sich aus Ihren ANVISA- oder FDA-Unterlagen wiederverwenden?<\/li><li>L\u00fccken hinsichtlich der MDR-Anforderungen an Sicherheit und Leistung<\/li><li>Kosmetika: CPSR, Produktinformationsdossier und EU-Etiketten<\/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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2c6782d e-flex e-con-boxed e-con e-parent\" data-id=\"2c6782d\" data-element_type=\"container\" data-e-type=\"container\" id=\"eu-products\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a296a85 animated-slow elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a296a85\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Was bringen Sie in die EU ein?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dc1e849 e-flex e-con-boxed e-con e-child\" data-id=\"dc1e849\" data-element_type=\"container\" data-e-type=\"container\" id=\"regulatory-path\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-56a071b animated-slow elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"56a071b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:400}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">F\u00fcr jedes Produkt gelten eigene EU-Vorschriften. W\u00e4hlen Sie Ihr Produkt aus, um den gesamten Prozess zu durchlaufen.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8c191d6 sobel-solutions-section e-con-full e-flex e-con e-child\" data-id=\"8c191d6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-8b9033b e-con-full e-flex e-con e-child\" data-id=\"8b9033b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1d29157 e-con-full e-flex e-con e-child\" data-id=\"1d29157\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4ace369 elementor-widget elementor-widget-image\" data-id=\"4ace369\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"534\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-1024x683.webp\" class=\"attachment-large size-large wp-image-47090\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-1024x683.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-768x512.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand.webp 1248w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5ddef11 e-con-full icone-segmento e-flex e-con e-child\" data-id=\"5ddef11\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-718a074 elementor-widget elementor-widget-image\" data-id=\"718a074\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"500\" height=\"500\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4.png\" class=\"attachment-large size-large wp-image-47094\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4.png 500w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-f6bb005 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f6bb005\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Medizinprodukte<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-223c9b7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"223c9b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Ger\u00e4te, Implantate und Software \u2013 von der Klassifizierung bis zur CE-Kennzeichnung.<\/p>\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-bca47e9 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"bca47e9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-grow\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\" arrow_right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Medizinprodukte in Europa<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d39bd55 e-con-full e-flex e-con e-child\" data-id=\"d39bd55\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d41995f e-con-full e-flex e-con e-child\" data-id=\"d41995f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_scale_effect&quot;:&quot;yes&quot;,&quot;motion_fx_scale_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;motion_fx_scale_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_scale_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:80}},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-524afc4 elementor-widget elementor-widget-image\" data-id=\"524afc4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"534\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-1024x683.webp\" class=\"attachment-large size-large wp-image-47098\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-1024x683.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-768x512.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand.webp 1248w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-caee5a2 e-con-full icone-segmento e-flex e-con e-child\" data-id=\"caee5a2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1471874 elementor-widget elementor-widget-image\" data-id=\"1471874\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"500\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4.png\" class=\"attachment-large size-large wp-image-47102\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4.png 500w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-e067318 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e067318\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Kosmetika<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-558b144 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"558b144\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Hautpflege, Make-up und K\u00f6rperpflege \u2013 von der CPSR- bis zur CPNP-Meldung.<\/p>\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-8a60370 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"8a60370\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-grow\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-cosmetics-eu\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\" arrow_right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Kosmetik in Europa<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-268b121 e-flex e-con-boxed e-con e-parent\" data-id=\"268b121\" data-element_type=\"container\" data-e-type=\"container\" id=\"local-presence\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-65d4d5f elementor-widget elementor-widget-html\" data-id=\"65d4d5f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbg\" id=\"eu-services\">\n<p class=\"sbg-ey\" data-k=\"ey\">DIENSTLEISTUNGEN IN DER EUROP\u00c4ISCHEN UNION<\/p>\n<h2 class=\"sbg-h\" data-k=\"h\">Alles, was wir f\u00fcr den EU-Markt tun<\/h2>\n<p class=\"sbg-sub\" data-k=\"sub\">Dokumentation, Beweisf\u00fchrung und Vertretung in Europa \u2013 alles aus einer Hand.<\/p>\n<div class=\"sbg-f\" role=\"group\" aria-label=\"Filter by product\">\n<button type=\"button\" class=\"sbg-c on\" data-f=\"all\" data-k=\"all\">Alle<\/button>\n<button type=\"button\" class=\"sbg-c\" data-f=\"md\"><span class=\"sbg-d\" style=\"background:#2A72C8\"><\/span><span data-k=\"md\">Medizinprodukte<\/span><\/button>\n<button type=\"button\" class=\"sbg-c\" data-f=\"co\"><span class=\"sbg-d\" style=\"background:#9471CF\"><\/span><span data-k=\"co\">Kosmetika<\/span><\/button>\n<\/div>\n<div class=\"sbg-g\">\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/de\/regulatory-qualitaet\/#registration\"><h3 data-k=\"t1\">Strategie und MDR-Einstufung<\/h3><p data-k=\"d1\">Ger\u00e4teklasse, Konformit\u00e4tsverfahren und Zeitplan.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/ce-mark-medical-devices-support\/\"><h3 data-k=\"t2\">Technische Dokumentation und CE-Kennzeichnung<\/h3><p data-k=\"d2\">Technische Unterlagen gem\u00e4\u00df MDR und Unterst\u00fctzung bei der Zusammenarbeit mit Ihrer Benannten Stelle.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/de\/regulatory-qualitaet\/#quality-systems\"><h3 data-k=\"t3\">Qualit\u00e4tsmanagementsystem (ISO 13485)<\/h3><p data-k=\"d3\">An die MDR angepasstes Qualit\u00e4tsmanagementsystem (QMS) sowie interne Audits.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/de\/klinische-evidenz-produktsicherheit\/#clinical-evaluation\"><h3 data-k=\"t4\">Biologische Beurteilung und klinische Bewertung<\/h3><p data-k=\"d4\">ISO 10993 und Ihr Bericht zur klinischen Bewertung (CER).<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"co\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-cosmetics-eu\/cosmetic-product-safety-report\/\"><h3 data-k=\"t5\">CPSR und Produktinformationsdatei<\/h3><p data-k=\"d5\">Von einem qualifizierten Sicherheitsgutachter unterzeichneter Sicherheitsbericht.<\/p><span class=\"sbg-tg\"><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"co\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-cosmetics-eu\/cpnp-notification-cpsr-service\/\"><h3 data-k=\"t6\">CPNP-Meldung und Kennzeichnung<\/h3><p data-k=\"d6\">Meldung im EU-Portal und \u00dcberpr\u00fcfung der Kennzeichnung.<\/p><span class=\"sbg-tg\"><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md co\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/european-authorized-representative-europe\/\" data-hco=\"\/our-solutions-cosmetics-eu\/\"><h3 data-k=\"t7\">EU-Vertretung<\/h3><p data-k=\"d7\">Bevollm\u00e4chtigter f\u00fcr Medizinprodukte, Verantwortliche Person f\u00fcr Kosmetika.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md co\" href=\"https:\/\/sobelconsult.com\/de\/so-arbeiten-wir\/#shw-models\"><h3 data-k=\"t8\">Laufende Unterst\u00fctzung<\/h3><p data-k=\"d8\">Monatliche Unterst\u00fctzung bei \u00c4nderungen, Verl\u00e4ngerungen und EU-Aktualisierungen.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><i class=\"co\"><\/i><\/span><\/a>\n<\/div>\n<\/div>\n<style>\n.sbg{max-width:1200px;margin:0 auto;font-family:'Host Grotesk',sans-serif;color:#2B2E34;text-align:center;scroll-margin-top:94px}\n.sbg-ey{display:inline-flex;align-items:center;gap:12px;margin:0;font-size:13px;font-weight:600;letter-spacing:.16em;color:#051B5A}\n.sbg-ey:before{content:\"\";width:9px;height:9px;border-radius:50%;background:#F2B705}\n.sbg-h{margin:20px 0 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.sbg-c.on:hover,.sbg .sbg-c.on:focus,.sbg .sbg-c.on:active{background:#051B5A!important;border-color:#051B5A!important;color:#FFFFFF!important}\n.sbg .sbg-c:focus-visible{outline:2px solid #F2B705!important;outline-offset:2px}\n.sbg .sbg-g{gap:20px;margin-top:28px}\n.sbg .sbg-t{padding:20px 22px}\n.sbg .sbg-t:hover,.sbg .sbg-t:focus{background:#FFFFFF!important;color:inherit!important}\n.sbg .sbg-t:hover h3{color:#051B5A!important}\n@media (min-width:768px) and (min-height:841px){\n.elementor .elementor-element-2c6782d .elementor-element.elementor-element-56a071b{margin:2px 0 24px!important}\n}\n@media (min-width:1025px) and (max-height:840px){\n.sbg .sbg-h{font-size:34px}\n.sbg .sbg-sub{display:none}\n.sbg .sbg-f{margin-top:20px}\n.sbg .sbg-g{gap:16px;margin-top:20px}\n.sbg .sbg-t{padding:16px 18px;gap:8px}\n.elementor .elementor-element-2c6782d .elementor-element.elementor-element-56a071b{margin:0 0 18px!important}\n}\n@media (max-width:1024px){\n.sbg .sbg-g{gap:16px}\n}\n@media (max-width:767px){\n.elementor .elementor-element-2c6782d .elementor-element.elementor-element-5ddef11,.elementor .elementor-element-2c6782d .elementor-element.elementor-element-caee5a2{width:76px!important;max-width:76px!important;--width:76px;align-self:center!important;margin:-38px auto 6px!important}\n.elementor .elementor-element-2c6782d .elementor-element-5ddef11 img,.elementor .elementor-element-2c6782d .elementor-element-caee5a2 img{width:76px!important;height:76px!important}\n.sbg .sbg-sub{margin-top:14px}\n.sbg .sbg-f{margin-top:20px}\n.sbg .sbg-g{grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin-top:20px}\n.sbg .sbg-t{padding:14px 12px;gap:8px;border-radius:14px}\n.sbg .sbg-t h3{font-size:15px;line-height:1.3}\n.sbg .sbg-t p{display:none}\n.sbg .sbg-tg i{width:20px;height:5px}\n.sbg .sbg-c{padding:6px 12px;min-height:40px;font-size:14px}\n}\n<\/style>\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-2ed0715 e-flex e-con-boxed e-con e-parent\" data-id=\"2ed0715\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e15dd9a elementor-widget elementor-widget-html\" data-id=\"e15dd9a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbs2\"><a href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/#sr-guide\" class=\"sbs2-c\"><span class=\"sbs2-i\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"26\" height=\"26\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\"><circle cx=\"6\" cy=\"19\" r=\"3\"><\/circle><path d=\"M9 19h8.5a3.5 3.5 0 0 0 0-7h-11a3.5 3.5 0 0 1 0-7H15\"><\/path><circle cx=\"18\" cy=\"5\" r=\"3\"><\/circle><\/svg><\/span><span class=\"sbs2-e\">WURDE DAS PRODUKT BEREITS ANDERSWO ZUGELASSEN?<\/span><span class=\"sbs2-t\">Nehmen Sie Ihre ANVISA- oder FDA-Unterlagen als Ausgangspunkt<\/span><span class=\"sbs2-d\">Pr\u00fcfen Sie, was f\u00fcr Europa wiederverwendet werden kann, bevor Sie sich auf ein Projekt festlegen.<\/span><span class=\"sbs2-l\">Gestalten Sie Ihren Weg mit Sobel Route \u2192<\/span><\/a><a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/european-authorized-representative-europe\/\" class=\"sbs2-c\"><span class=\"sbs2-i\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"26\" height=\"26\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\"><path d=\"M12 22s8-4 8-10V5l-8-3-8 3v7c0 6 8 10 8 10z\"><\/path><path d=\"m9 12 2 2 4-4\"><\/path><\/svg><\/span><span class=\"sbs2-e\">BEN\u00d6TIGEN SIE EINEN EU-VERTRETER?<\/span><span class=\"sbs2-t\">Erforderlich f\u00fcr Hersteller au\u00dferhalb der EU<\/span><span class=\"sbs2-d\">Sobel fungiert als Ihr Bevollm\u00e4chtigter f\u00fcr Medizinprodukte und als Verantwortliche Person f\u00fcr Kosmetika.<\/span><span class=\"sbs2-l\">Erfahren Sie mehr \u00fcber den Service \u201eBevollm\u00e4chtigter Vertreter\u201c \u2192<\/span><\/a><\/div><style>.sbs2{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:24px;font-family:'Host Grotesk',sans-serif}.sbs2-c{display:flex;flex-direction:column;gap:10px;background:#051B5A;border-radius:18px;padding:30px;text-decoration:none;transition:transform .25s ease}.sbs2-c:hover{transform:translateY(-3px)}.sbs2-i{width:52px;height:52px;border-radius:50%;border:1.5px solid #F2B705;display:flex;align-items:center;justify-content:center}.sbs2-e{font-size:13px;font-weight:700;letter-spacing:.14em;color:#F2B705;margin-top:6px}.sbs2-t{font-family:Lora,Georgia,serif;font-weight:700;font-size:24px;line-height:1.25;color:#FFFFFF}.sbs2-d{font-size:16px;line-height:1.55;color:#D9DFEE}.sbs2-l{margin-top:auto;padding-top:8px;font-weight:600;color:#F2B705;font-size:15.5px}@media(max-width:767px){.sbs2{grid-template-columns:minmax(0,1fr)}.sbs2-t{font-size:21px}}<\/style>\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-a19c938 e-con-full e-flex e-con e-parent\" data-id=\"a19c938\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c25134c elementor-widget elementor-widget-template\" data-id=\"c25134c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"container\" data-elementor-id=\"46190\" class=\"elementor elementor-46190 elementor-46189 elementor-46189\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fc3d48 e-flex e-con-boxed e-con e-parent\" data-id=\"5fc3d48\" data-element_type=\"container\" data-e-type=\"container\" id=\"why-sobel\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-629f752 sbw-native e-flex e-con-boxed e-con e-child\" data-id=\"629f752\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f0eb2c5 e-con-full sbw-l e-flex e-con e-child\" data-id=\"f0eb2c5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a36dc14 elementor-widget elementor-widget-heading\" data-id=\"a36dc14\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Warum Sobel<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c265d3 elementor-widget elementor-widget-heading\" data-id=\"3c265d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Regulierung als <span class=\"sbw-gold\">Gesch\u00e4ftsentscheidung,<\/span> nicht als Checkliste.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-85f7a25 elementor-widget elementor-widget-text-editor\" data-id=\"85f7a25\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>An jedem Projekt arbeiten vier Fachbereiche im selben Team zusammen \u2013 von der ersten Entscheidung bis hin zur Zeit nach der Markteinf\u00fchrung.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a67f4ac e-con-full e-grid e-con e-child\" data-id=\"a67f4ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-693f1b5 e-con-full e-flex e-con e-child\" data-id=\"693f1b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85f3478 elementor-widget elementor-widget-heading\" data-id=\"85f3478\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Strategie<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97525b9 elementor-widget elementor-widget-text-editor\" data-id=\"97525b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Zun\u00e4chst werden die Klassifizierung und die Marktabfolge festgelegt. Die Wahl der richtigen Klasse vom ersten Tag an verhindert Nacharbeiten.<\/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<div class=\"elementor-element elementor-element-6495a0a e-con-full e-flex e-con e-child\" data-id=\"6495a0a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-836adaf elementor-widget elementor-widget-heading\" data-id=\"836adaf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Eigene Wissenschaft<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67ceef1 elementor-widget elementor-widget-text-editor\" data-id=\"67ceef1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Biologische Beurteilung, klinische Bewertung und toxikologische Beurteilung durch unser eigenes Team f\u00fcr klinische Evidenz und Produktsicherheit.<\/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<div class=\"elementor-element elementor-element-32f324f e-con-full e-flex e-con e-child\" data-id=\"32f324f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42f4202 elementor-widget elementor-widget-heading\" data-id=\"42f4202\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Regulierung, f\u00fcnf M\u00e4rkte<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af07af2 elementor-widget elementor-widget-text-editor\" data-id=\"af07af2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>ANVISA, die FDA, die EU-MDR, die MHRA und Health Canada haben sich untereinander abgestimmt.<\/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<div class=\"elementor-element elementor-element-509c85a e-con-full e-flex e-con e-child\" data-id=\"509c85a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e1ba45f elementor-widget elementor-widget-heading\" data-id=\"e1ba45f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Technologie<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c8184f elementor-widget elementor-widget-text-editor\" data-id=\"2c8184f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Ein engagiertes Technologieteam entwickelt die Arbeitsabl\u00e4ufe, die daf\u00fcr sorgen, dass jedes Projekt nachvollziehbar bleibt und termingerecht abgewickelt wird.<\/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<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4d1d951 e-con-full sbw-card e-flex e-con e-child\" data-id=\"4d1d951\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-afde0f5 elementor-widget elementor-widget-text-editor\" data-id=\"afde0f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u201eWir wissen, wie Auditoren denken, denn wir waren selbst einmal einer von ihnen.\u201c<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4b051b4 e-con-full e-flex e-con e-child\" data-id=\"4b051b4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed4939a elementor-widget elementor-widget-image\" data-id=\"ed4939a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp\" class=\"attachment-medium size-medium wp-image-44765\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-150x150.webp 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-768x768.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait.webp 800w\" 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<\/div>\n\t\t<div class=\"elementor-element elementor-element-0a86da7 e-con-full e-flex e-con e-child\" data-id=\"0a86da7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ea43503 elementor-widget elementor-widget-heading\" data-id=\"ea43503\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Maik Endler<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d696004 elementor-widget elementor-widget-heading\" data-id=\"d696004\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Gr\u00fcnder und Gesch\u00e4ftsf\u00fchrer<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c430b7 elementor-widget elementor-widget-text-editor\" data-id=\"7c430b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Maschinenbauingenieur, in Deutschland ausgebildet<\/li><li>Ehemaliger BSI-Auditor (Benannte Stelle)<\/li><li>Branchenerfahrung bei Sirona (jetzt Dentsply Sirona)<\/li><\/ul>\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-87729bb elementor-align-left elementor-widget elementor-widget-button\" data-id=\"87729bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/de\/home\/about-us\/\">\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\">Lernen Sie das Team kennen \u2192<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-446ce21 elementor-widget elementor-widget-html\" data-id=\"446ce21\" 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p.sbf-lead{margin:0;font-size:17px;line-height:1.55}\n.sbf-btn{align-self:flex-start;background:#051B5A;color:#fff !important;text-decoration:none;border-radius:999px;padding:14px 26px;font-weight:600;font-size:16px}\n.sbf-btn:hover{background:#0E2C77}\n.sbf-list{flex:2 1 540px;min-width:0;display:flex;flex-direction:column;gap:12px}\n.sbf-item{background:#fff;border:1px solid rgba(5,27,90,.16);border-radius:14px;box-shadow:0 1px 2px rgba(5,27,90,.08);transition:box-shadow .2s}\n.sbf-item[open]{border-left:4px solid #F2B705;box-shadow:0 1px 2px rgba(5,27,90,.10),0 10px 24px rgba(5,27,90,.07)}\n.sbf-item summary{list-style:none;cursor:pointer;display:flex;justify-content:space-between;align-items:center;gap:20px;padding:20px 22px;font-size:17px;font-weight:600;color:#051B5A}\n.sbf-item summary::-webkit-details-marker{display:none}\n.sbf-item summary:focus-visible{outline:2px solid #051B5A;outline-offset:2px;border-radius:12px}\n.sbf-item summary i{flex:0 0 32px;height:32px;border-radius:50%;border:1.5px solid #D9A400;position:relative}\n.sbf-item summary i:before,.sbf-item summary i:after{content:\"\";position:absolute;left:50%;top:50%;width:12px;height:1.6px;background:#051B5A;transform:translate(-50%,-50%)}\n.sbf-item summary i:after{transform:translate(-50%,-50%) rotate(90deg);transition:transform .2s}\n.sbf-item[open] summary i:after{transform:translate(-50%,-50%) rotate(0deg)}\n.sbf-a{padding:0 22px 20px}\n.sbf-a p{margin:0;font-size:16px;line-height:1.6;color:#2B2E34;max-width:720px}\n@media(max-width:767px){.sbf-intro h2{font-size:32px}.sbf{gap:32px}}\n<\/style>\n<div class=\"sbf\">\n<div class=\"sbf-intro\"><p class=\"sbf-eye\">H\u00e4ufig gestellte Fragen \u00b7 EUROP\u00c4ISCHE UNION<\/p><h2>Was Unternehmen vor dem Markteintritt in die <em>EU<\/em> wissen m\u00fcssen<\/h2><p class=\"sbf-lead\">Kurze Antworten zu Medizinprodukten und Kosmetika. Auf jeder Produktseite finden Sie detaillierte Informationen.<\/p><a class=\"sbf-btn\" href=\"#footer-cta\">Stellen Sie Ihre Frage \u2192<\/a><\/div>\n<div class=\"sbf-list\"><details class=\"sbf-item\" open=\"\"><summary><span>Welche Vorschriften gelten in der EU f\u00fcr Medizinprodukte und Kosmetika?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Medizinprodukte unterliegen <strong>der Verordnung (EU) 2017\/745 (MDR)<\/strong> und Kosmetika <strong>der Verordnung (EG) Nr. 1223\/2009<\/strong>. Beide gelten unmittelbar in jedem EU-Mitgliedstaat.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Ben\u00f6tige ich einen Bevollm\u00e4chtigten in der EU?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Ja. Medizinproduktehersteller mit Sitz au\u00dferhalb der EU m\u00fcssen einen <strong>Bevollm\u00e4chtigten<\/strong> benennen (MDR, Artikel 11). F\u00fcr jedes Kosmetikprodukt ist eine in der EU ans\u00e4ssige <strong>verantwortliche Person<\/strong> erforderlich (Verordnung 1223\/2009, Artikel 4). Sobel bietet beide Dienstleistungen an. <a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/european-authorized-representative-europe\/\">Erfahren Sie mehr \u00fcber den Bevollm\u00e4chtigten-Service<\/a>.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Ben\u00f6tigt mein Produkt eine Benannte Stelle?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Das h\u00e4ngt von der Klasse ab. Die meisten Produkte <strong>der Klasse I<\/strong> werden vom Hersteller selbst deklariert. Produkte der Klasse I, die steril sind, eine Messfunktion haben oder wiederverwendbare chirurgische Instrumente sind, sowie alle Produkte <strong>der Klassen IIa, IIb und III<\/strong> ben\u00f6tigen eine Benannte Stelle.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Was ist f\u00fcr ein Kosmetikprodukt erforderlich, bevor es in der EU in Verkehr gebracht werden darf?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Einen von einem qualifizierten Sicherheitsgutachter unterzeichneten <strong>Sicherheitsbericht f\u00fcr Kosmetikprodukte (CPSR)<\/strong>, ein von der verantwortlichen Person gef\u00fchrtes <strong>Produktinformationsdossier<\/strong>, eine Meldung im <strong>CPNP<\/strong> sowie Etiketten, die den Anforderungen der Verordnung entsprechen.<\/p><\/div><\/details><\/div>\n<\/div>\n<script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Which rules apply to medical devices and cosmetics in the EU?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Medical devices follow Regulation (EU) 2017\/745 (MDR) and cosmetics follow Regulation (EC) No 1223\/2009. 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Sobel unterst\u00fctzt die Klassifizierung, Registrierung und regulatorische Strategie f\u00fcr die Marktzulassung.<\/p>\n","protected":false},"author":18,"featured_media":25478,"parent":41035,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_angie_page":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-47360","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Markteintritt in der EU: Einhaltung der MDR- und Kosmetikvorschriften | Sobel<\/title>\n<meta name=\"description\" content=\"Inverkehrbringen von Medizinprodukten und Kosmetika auf dem EU-Markt: MDR-Einstufung, CE-Kennzeichnung, CPSR, CPNP und Sobel als Ihr EU-Bevollm\u00e4chtigter.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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