{"id":4923,"date":"2025-10-16T10:55:20","date_gmt":"2025-10-16T09:55:20","guid":{"rendered":"https:\/\/www.fytofontana.com\/?page_id=4923"},"modified":"2025-11-03T12:52:16","modified_gmt":"2025-11-03T11:52:16","slug":"mdr","status":"publish","type":"page","link":"https:\/\/www.fytofontana.com\/pl\/mdr\/","title":{"rendered":"MDR"},"content":{"rendered":"\n<h2><\/h2>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container\"><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\">Nasze wyroby medyczne spe\u0142niaj\u0105 wymagania rozporz\u0105dzenia MDR 2017\/745<\/h2>\n\t\t\t<p><!-- wp:paragraph --><\/p>\n<p>Firma <strong>Herb-Pharma AG<\/strong> pomy\u015blnie przesz\u0142a proces certyfikacji zgodnie z <strong>Rozporz\u0105dzeniem Parlamentu Europejskiego i Rady (UE) 2017\/745 w sprawie wyrob\u00f3w medycznych (MDR).<\/strong><\/p>\n<p>Tym samym nasze produkty spe\u0142niaj\u0105 najsurowsze europejskie wymagania dotycz\u0105ce bezpiecze\u0144stwa, skuteczno\u015bci i jako\u015bci wyrob\u00f3w medycznych.<\/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 src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/199e47657d44c-1-e1760477747643.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\">Certyfikaty produkt\u00f3w<\/h2>\n\t\t\t<p>Na podstawie oceny przeprowadzonej przez jednostk\u0119 notyfikowan\u0105 <strong>3EC International a.s., NB 2265<\/strong>, nast\u0119puj\u0105ce wyroby medyczne uzyska\u0142y certyfikat zgodno\u015bci z MDR:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.fytofontana.com\/pl\/Produkty\/virostop-pl\/\" target=\"_blank\" rel=\"noopener\"><strong>fytofontana VIROSTOP<\/strong><\/a> \u2013 spray do jamy ustnej, spray do nosa i pastylki do ssania (wyr\u00f3b medyczny klasy IIa)<\/li>\n<li><a href=\"https:\/\/www.fytofontana.com\/pl\/Produkty\/gyntima-pl\/\" target=\"_blank\" rel=\"noopener\"><strong>fytofontana GYNTIMA<\/strong><\/a> \u2013 globulki dopochwowe (wyr\u00f3b medyczny klasy 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 Certyfikat systemu zarz\u0105dzania jako\u015bci\u0105 UE 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 Certyfikat systemu zarz\u0105dzania jako\u015bci\u0105 UE 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 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\">W trakcie certyfikacji MDR<\/h2>\n\t\t\t<p>Wyroby medyczne marek <a href=\"https:\/\/www.fytofontana.com\/pl\/Produkty\/aurecon-pl\/\" target=\"_blank\" rel=\"noopener\"><strong>AURECON<\/strong> (krople i spraye do uszu)<\/a> oraz <a href=\"https:\/\/www.fytofontana.com\/pl\/Produkty\/hemorrelax-pl\/\" target=\"_blank\" rel=\"noopener\"><strong>HEMORRELAX<\/strong> (krem i czopki doodbytnicze)<\/a> s\u0105 ju\u017c w trakcie procesu certyfikacji MDR.<\/p>\n<p>Jednostka notyfikowana <strong>3EC International a.s.<\/strong> potwierdzi\u0142a przyj\u0119cie formalnego wniosku, podpisanie pisemnej umowy i sprawuje odpowiedni nadz\u00f3r zgodnie z <strong>Rozporz\u0105dzeniem (UE) 2023\/607<\/strong>, kt\u00f3re reguluje przepisy przej\u015bciowe dla wyrob\u00f3w medycznych w ramach systemu MDR.<\/p>\n<p>Dlatego te\u017c produkty te s\u0105 wprowadzane do obrotu w pe\u0142nej zgodno\u015bci z obowi\u0105zuj\u0105cym prawodawstwem europejskim i podlegaj\u0105 odpowiedniemu monitorowaniu zgodnie z umowami zawartymi z jednostk\u0105 notyfikowan\u0105.<\/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 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\">System zarz\u0105dzania jako\u015bci\u0105 zgodny z norm\u0105 EN ISO 13485:2016<\/h2>\n\t\t\t<p><strong>Herb-Pharma AG<\/strong> posiada r\u00f3wnie\u017c <strong>certyfikat systemu zarz\u0105dzania jako\u015bci\u0105 zgodny z norm\u0105 EN ISO 13485:2016, wydany zgodnie z Rozporz\u0105dzeniem Parlamentu Europejskiego i Rady (UE) 2017\/745 w sprawie wyrob\u00f3w medycznych (MDR).<\/strong><\/p>\n<p>Certyfikat ten potwierdza, \u017ce procesy projektowania, rozwoju i produkcji wyrob\u00f3w medycznych spe\u0142niaj\u0105 mi\u0119dzynarodowo uznane standardy jako\u015bci i s\u0105 w pe\u0142ni zgodne z wymaganiami MDR.<\/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_EN.pdf\" target=\"_blank\" rel=\"noopener\"><br \/>\nCertyfikat 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 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\">Dlaczego jest to wa\u017cne?<\/h2>\n\t\t\t<p>Dzi\u0119ki tym certyfikatom nasze wyroby medyczne mog\u0105 by\u0107 <strong>nadal legalnie wprowadzane do obrotu, dystrybuowane i sprzedawane na rynku<\/strong> w krajach Unii Europejskiej.<\/p>\n<p>Dla naszych partner\u00f3w i klient\u00f3w jest to gwarancja, \u017ce ka\u017cdy produkt <strong>Herb-Pharma AG<\/strong> powstaje zgodnie z europejskim prawodawstwem, <strong>w ramach rygorystycznego systemu zarz\u0105dzania i kontroli jako\u015bci<\/strong> oraz poddany jest niezale\u017cnej ocenie przez jednostk\u0119 notyfikowan\u0105.<\/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 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":[],"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\" href=\"https:\/\/www.fytofontana.com\/pl\/mdr\/\" \/>\n<meta property=\"og:locale\" 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