{"id":5044,"date":"2025-11-03T13:01:48","date_gmt":"2025-11-03T12:01:48","guid":{"rendered":"https:\/\/www.fytofontana.com\/?page_id=5044"},"modified":"2025-11-03T13:01:48","modified_gmt":"2025-11-03T12:01:48","slug":"mdr","status":"publish","type":"page","link":"https:\/\/www.fytofontana.com\/hu\/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\">Orvostechnikai eszk\u00f6zeink megfelelnek az MDR 2017\/745 rendelet k\u00f6vetelm\u00e9nyeinek<\/h2>\n\t\t\t<p><!-- wp:paragraph --><\/p>\n<p>A <strong>Herb-Pharma AG<\/strong> eredm\u00e9nyesen z\u00e1rta az orvostechnikai eszk\u00f6z\u00f6kre vonatkoz\u00f3 <strong>(EU) 2017\/745 eur<\/strong><strong>\u00f3pai parlamenti <\/strong><strong>\u00e9<\/strong><strong>s tan\u00e1csi rendelet (MDR)<\/strong> szerinti tan\u00fas\u00edt\u00e1si folyamatot.<\/p>\n<p>Term\u00e9keink \u00edgy megfelelnek az orvostechnikai eszk\u00f6z\u00f6k biztons\u00e1g\u00e1ra, hat\u00e1soss\u00e1g\u00e1ra \u00e9s min\u0151s\u00e9g\u00e9re vonatkoz\u00f3 legszigor\u00fabb eur\u00f3pai k\u00f6vetelm\u00e9nyeknek.<\/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-e1760477646701.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\">Term\u00e9ktan\u00fas\u00edtv\u00e1nyok<\/h2>\n\t\t\t<p>A <strong>3EC International a.s. (NB 2265)<\/strong> kijel\u00f6lt szervezet \u00e9rt\u00e9kel\u00e9se alapj\u00e1n az al\u00e1bbi orvostechnikai eszk\u00f6z\u00f6k kaptak sikeres MDR tan\u00fas\u00edtv\u00e1nyt:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.fytofontana.com\/hu\/termekek\/virostop\/\" target=\"_blank\" rel=\"noopener\"><strong>fytofontana VIROSTOP<\/strong><\/a> \u2013 sz\u00e1jspray, orrspray \u00e9s pasztill\u00e1k (IIa. kock\u00e1zati oszt\u00e1ly\u00fa orvostechnikai eszk\u00f6z)<\/li>\n<li><a href=\"https:\/\/www.fytofontana.com\/hu\/termekek\/gyntima-hu\/\" target=\"_blank\" rel=\"noopener\"><strong>fytofontana GYNTIMA<\/strong><\/a> \u2013 h\u00fcvelyk\u00fapok (IIb. kock\u00e1zati oszt\u00e1ly\u00fa orvostechnikai eszk\u00f6z)<\/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 Quality Management System Certificate No. 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 Quality Management System Certificate No. 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\">Tov\u00e1bbi term\u00e9keink MDR tan\u00fas\u00edt\u00e1si folyamata is megkezd\u0151d\u00f6tt<\/h2>\n\t\t\t<p>Az <a href=\"https:\/\/www.fytofontana.com\/hu\/termekek\/aurecon\/\" target=\"_blank\" rel=\"noopener\"><strong>AURECON<\/strong><\/a> (f\u00fclcsepp \u00e9s -spray) \u00e9s a <a href=\"https:\/\/www.fytofontana.com\/hu\/termekek\/hemorrelax\/\" target=\"_blank\" rel=\"noopener\"><strong>HEMORRELAX<\/strong><\/a> (v\u00e9gb\u00e9lkr\u00e9m \u00e9s v\u00e9gb\u00e9lk\u00fap) m\u00e1rk\u00e1khoz tartoz\u00f3 orvostechnikai eszk\u00f6z\u00f6k MDR tan\u00fas\u00edtv\u00e1ny\u00e1nak megszerz\u00e9se is folyamatban van.<\/p>\n<p>A <strong>3EC International a.s.<\/strong> kijel\u00f6lt szervezet meger\u0151s\u00edtette a hivatalos k\u00e9relem befogad\u00e1s\u00e1t, az \u00edr\u00e1sbeli meg\u00e1llapod\u00e1s al\u00e1\u00edr\u00e1s\u00e1t, \u00e9s biztos\u00edtja az <strong>(EU) 2023\/607 rendelet <\/strong>\u2013 , amely az orvostechnikai eszk\u00f6z\u00f6k MDR rendszerbe t\u00f6rt\u00e9n\u0151 \u00e1tmin\u0151s\u00edt\u00e9s\u00e9t szab\u00e1lyozza, \u2013 alapj\u00e1n t\u00f6rt\u00e9n\u0151 megfelel\u0151 fel\u00fcgyeletet.<\/p>\n<p>Ezek a term\u00e9kek ez\u00e9rt a hat\u00e1lyos eur\u00f3pai jogszab\u00e1lyokkal teljes \u00f6sszhangban ker\u00fclnek forgalomba, \u00e9s a kijel\u00f6lt szervezettel k\u00f6t\u00f6tt meg\u00e1llapod\u00e1sok szerint szab\u00e1lyszer\u0171en fel\u00fcgyeltek.<\/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\">EN ISO 13485:2016 szerinti min\u0151s\u00e9gir\u00e1ny\u00edt\u00e1si rendszer<\/h2>\n\t\t\t<p>A <strong>Herb-Pharma AG<\/strong> rendelkezik az <strong>EN ISO 13485:2016 szabv\u00e1ny szerinti min\u0151s<\/strong><strong>\u00e9gir\u00e1ny\u00edt\u00e1si rendszer tan\u00fas\u00edtv\u00e1ny\u00e1val is, amelyet az orvostechnikai eszk<\/strong><strong>\u00f6z<\/strong><strong>\u00f6kr\u0151l sz<\/strong><strong>\u00f3l\u00f3 (EU) 2017\/745 eur<\/strong><strong>\u00f3pai parlamenti <\/strong><strong>\u00e9<\/strong><strong>s tan\u00e1csi rendelettel (MDR) <\/strong><strong>\u00f6sszhangban adtak ki.<\/strong><\/p>\n<p>Ez a tan\u00fas\u00edtv\u00e1ny igazolja, hogy az orvostechnikai eszk\u00f6z\u00f6k tervez\u00e9si, fejleszt\u00e9si \u00e9s gy\u00e1rt\u00e1si folyamatai megfelelnek a nemzetk\u00f6zileg elismert min\u0151s\u00e9gi szabv\u00e1nyoknak, \u00e9s teljes m\u00e9rt\u00e9kben \u00f6sszhangban vannak az MDR k\u00f6vetelm\u00e9nyeivel.<\/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 \/>\nCertificate 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\">Mi\u00e9rt fontos ez?<\/h2>\n\t\t\t<p>Ezeknek a tan\u00fas\u00edtv\u00e1nyoknak k\u00f6sz\u00f6nhet\u0151en orvostechnikai eszk\u00f6zeink tov\u00e1bbra is jogszer\u0171en forgalmazhat\u00f3k, terjeszthet\u0151k \u00e9s \u00e9rt\u00e9kes\u00edthet\u0151k az Eur\u00f3pai Uni\u00f3 orsz\u00e1gaiban.<\/p>\n<p>Partnereink \u00e9s v\u00e1s\u00e1rl\u00f3ink sz\u00e1m\u00e1ra ez garant\u00e1lja, hogy minden <strong>Herb-Pharma AG<\/strong> term\u00e9k az eur\u00f3pai jogszab\u00e1lyoknak megfelel\u0151en, <strong>szigor\u00fa min\u0151s\u00e9gir\u00e1ny\u00edt\u00e1si \u00e9s -ellen\u0151rz\u00e9si rendszer k\u00f6vetelm\u00e9nyeinek eleget t\u00e9ve<\/strong>, valamint egy kijel\u00f6lt szervezet f\u00fcggetlen \u00e9rt\u00e9kel\u00e9se mellett k\u00e9sz\u00fcl.<\/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-5044","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\" href=\"https:\/\/www.fytofontana.com\/hu\/mdr\/\" \/>\n<meta property=\"og:locale\" content=\"hu_HU\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR - Fytofontana\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.fytofontana.com\/hu\/mdr\/\" \/>\n<meta property=\"og:site_name\" content=\"Fytofontana\" \/>\n<meta property=\"og:image\" 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