{"id":4968,"date":"2025-10-16T11:44:02","date_gmt":"2025-10-16T10:44:02","guid":{"rendered":"https:\/\/www.fytofontana.com\/?page_id=4968"},"modified":"2025-10-16T12:01:29","modified_gmt":"2025-10-16T11:01:29","slug":"mdr","status":"publish","type":"page","link":"https:\/\/www.fytofontana.com\/de\/mdr\/","title":{"rendered":"MDR"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><\/h2>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\"><section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Unsere Medizinprodukte erf\u00fcllen die Anforderungen der MDR 2017\/745<\/h2>\n\t\t\t<p><!-- wp:paragraph --><\/p>\n<p><strong>Die Herb-Pharma AG<\/strong> hat den Zertifizierungsprozess gem\u00e4\u00df der <strong>Verordnung (EU) 2017\/745 des Europ\u00e4ischen Parlaments und des Rates \u00fcber Medizinprodukte (MDR) erfolgreich abgeschlossen.<\/strong><\/p>\n<p>Unsere Produkte erf\u00fcllen somit die strengsten europ\u00e4ischen Anforderungen an die Sicherheit, Leistungsf\u00e4higkeit und Qualit\u00e4t von Medizinprodukten.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img decoding=\"async\" src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/199e47657d44c-1-e1760478255649.png\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n<\/div><\/div>\n\n\n<section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Produktzertifizierungen<\/h2>\n\t\t\t<p>Auf Grundlage der Bewertung durch die Benannte Stelle <strong>3EC International a.s., NB 2265<\/strong>, wurden die folgenden Medizinprodukte erfolgreich nach der MDR zertifiziert:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.fytofontana.com\/de\/products\/virostop-de\/\" target=\"_blank\" rel=\"noopener\"><strong>fytofontana VIROSTOP<\/strong><\/a> \u2013 Mundspray, Nasenspray und Lutschtabletten (Medizinprodukt der Klasse IIa)<\/li>\n<li><a href=\"https:\/\/www.fytofontana.com\/de\/products\/gyntima-de\/\" target=\"_blank\" rel=\"noopener\"><strong>fytofontana GYNTIMA<\/strong><\/a> \u2013 Vaginalz\u00e4pfchen (Medizinprodukt der Klasse IIb)<\/li>\n<\/ul>\n<p style=\"margin-top: 15px;\">\ud83d\udcc4 <a style=\"color: #3e5435; font-weight: bold; text-decoration: none;\" href=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/F17A1_NR_EN_EU-Quality-Management-System-Certificate_VIROSTOP-HerbPharma.pdf\" target=\"_blank\" rel=\"noopener\"><br \/>\nVIROSTOP \u2013 EU-Zertifikat des Qualit\u00e4tsmanagementsystems Nr. 2024-MDR\/QS-023\/A<\/a><\/p>\n<p>\ud83d\udcc4 <a style=\"color: #3e5435; font-weight: bold; text-decoration: none;\" href=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/F17A1_NR_EN_EU-Quality-Management-System-Certificate_GYNTIMA-HerbPharma.pdf\" target=\"_blank\" rel=\"noopener\"><br \/>\nGYNTIMA \u2013 EU-Zertifikat des Qualit\u00e4tsmanagementsystems Nr. 2025-MDR\/QS-003<\/a><\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img decoding=\"async\" src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/Dizajn-bez-nazvu-1.jpg\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n\n\n<section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Im MDR-Zertifizierungsprozess<\/h2>\n\t\t\t<p>Die Medizinprodukte der Marken <a href=\"https:\/\/www.fytofontana.com\/de\/products\/aurecon-de\/\" target=\"_blank\" rel=\"noopener\"><strong>AURECON<\/strong> (Ohrentropfen und -sprays)<\/a> und <a href=\"https:\/\/www.fytofontana.com\/de\/products\/hemorrelax-de\/\" target=\"_blank\" rel=\"noopener\"><strong>HEMORRELAX<\/strong> (Rektalcreme und -z\u00e4pfchen)<\/a> befinden sich bereits im MDR-Zertifizierungsprozess.<\/p>\n<p>Die Benannte Stelle <strong>3EC International a.s.<\/strong> hat den Eingang des f\u00f6rmlichen Antrags sowie die Unterzeichnung einer schriftlichen Vereinbarung best\u00e4tigt und f\u00fchrt eine angemessene \u00dcberwachung gem\u00e4\u00df der <strong>Verordnung (EU) 2023\/607<\/strong> durch, welche die \u00dcbergangsbestimmungen f\u00fcr Medizinprodukte im Rahmen des MDR-Systems regelt.<\/p>\n<p>Diese Produkte werden daher in voller \u00dcbereinstimmung mit den geltenden europ\u00e4ischen Rechtsvorschriften in Verkehr gebracht und gem\u00e4\u00df den mit der Benannten Stelle geschlossenen Vereinbarungen ordnungsgem\u00e4\u00df \u00fcberwacht.<\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img decoding=\"async\" src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/Dizajn-bez-nazvu-1-1.jpg\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n\n\n<section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Qualit\u00e4tsmanagementsystem nach EN ISO 13485:2016<\/h2>\n\t\t\t<p><strong>Die Herb-Pharma AG<\/strong> besitzt zudem <strong>ein Zertifikat f\u00fcr ihr Qualit\u00e4tsmanagementsystem nach der Norm EN ISO 13485:2016, das in \u00dcbereinstimmung mit der Verordnung (EU) 2017\/745 \u00fcber Medizinprodukte (MDR) ausgestellt wurde.<\/strong><\/p>\n<p>Dieses Zertifikat best\u00e4tigt, dass die Prozesse der Auslegung, Entwicklung und Herstellung von Medizinprodukten international anerkannten Qualit\u00e4tsstandards entsprechen und vollst\u00e4ndig mit den Anforderungen der MDR \u00fcbereinstimmen.<\/p>\n<p style=\"margin-top: 15px;\">\ud83d\udcc4 <a style=\"color: #3e5435; font-weight: bold; text-decoration: none;\" href=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/M-0549-23_Herb-Pharma_DE.pdf\" target=\"_blank\" rel=\"noopener\"><br \/>\nZertifikat EN ISO 13485:2016 <\/a><\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img decoding=\"async\" src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/Snimka-obrazovky-2025-04-03-112927.png\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n\n\n<section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Warum das wichtig ist<\/h2>\n\t\t\t<p>Dank dieser Zertifizierungen k\u00f6nnen <strong>unsere Medizinprodukte weiterhin legal in den L\u00e4ndern der Europ\u00e4ischen Union in Verkehr gebracht<\/strong>, vertrieben und verkauft werden.<\/p>\n<p>F\u00fcr unsere Partner und Kunden ist dies die Garantie, dass jedes Produkt der <strong>Herb-Pharma AG<\/strong> in \u00dcbereinstimmung mit der europ\u00e4ischen Gesetzgebung, <strong>unter einem strengen<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img decoding=\"async\" src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/ChatGPT-Image-15.-10.-2025-21_30_32_jpg.jpg\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4968","page","type-page","status-publish","hentry"],"yoast_head":"<title>MDR - Fytofontana<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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