{"id":3315,"date":"2025-08-04T20:04:49","date_gmt":"2025-08-04T20:04:49","guid":{"rendered":"https:\/\/nano-test.de\/?p=3315"},"modified":"2025-08-04T20:23:52","modified_gmt":"2025-08-04T20:23:52","slug":"wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/","title":{"rendered":"How do the new regulations for medical devices in Europe affect the development of biomaterials?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3315\" class=\"elementor elementor-3315\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1cc9302a ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1cc9302a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-534fb0be ts-bg-color-over-image\" data-id=\"534fb0be\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8cc5566 elementor-widget elementor-widget-text-editor\" data-id=\"8cc5566\" 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><span style=\"color: #000000;\">Mit den 2021 in Kraft getretenen Verordnungen <strong>MDR 2017\/745<\/strong> and <strong>IVDR (2017\/746)<\/strong> wurden die Sicherheits- und Transparenzkriterien f\u00fcr <a href=\"https:\/\/nano-test.de\/en\/service\/medizinprodukt\/\">Medical devices<\/a> durch die Europ\u00e4ische Union erheblich versch\u00e4rft. Damit wurden f\u00fcr Forscher, die biomaterialbasierte Produkte entwickeln, eine Reihe neuer anspruchsvoller Bedingungen f\u00fcr den \u00dcbergang zur klinischen Anwendung eingef\u00fchrt.<\/span><\/p><p><span style=\"color: #000000;\">In this article, we would like to give you an overview of the \u201eImpact of the Medical Device Regulation on the Development of Biomaterials\u201c, based on the results of a scientific study published by Jurczak and colleagues in 2024 in the journal Bioengineering &amp; Translational Medicine.<\/span><\/p><blockquote><p><span style=\"color: #000000;\"><em>\u201eThe new regulations not only bring compliance obligations but also structural changes regarding clinical safety and data standardization.\u201c<\/em><\/span><\/p><p><span style=\"color: #000000;\">\u2014 <strong>Jurczak et al., 2024<\/strong><\/span><\/p><\/blockquote><p><span style=\"color: #000000;\"><strong>Before we delve deeper into this, let us first familiarize ourselves with the terms MDR and IVDR.<\/strong><\/span><\/p><h3><span style=\"color: #000000;\"><strong>What are MDR and IVDR in a nutshell?<\/strong><\/span><\/h3><table width=\"670\"><thead><tr><td><strong><span style=\"color: #000000;\">Criterion<\/span><\/strong><\/td><td><span style=\"color: #000000;\"><strong>MDR 2017\/745<\/strong><\/span><\/td><td><span style=\"color: #000000;\"><strong>IVDR (2017\/746)<\/strong><\/span><\/td><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\">Scope<\/span><\/td><td><span style=\"color: #000000;\">All medical devices<\/span><\/td><td><span style=\"color: #000000;\">In-vitro diagnostics<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\">innovation<\/span><\/td><td><span style=\"color: #000000;\">Clinical evaluation, UDI system<\/span><\/td><td><span style=\"color: #000000;\">Performance demonstration, reclassification<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\">Objective<\/span><\/td><td><span style=\"color: #000000;\">Improvement of patient safety<\/span><\/td><td><span style=\"color: #000000;\">Ensuring diagnostic accuracy and traceability<\/span><\/td><\/tr><\/tbody><\/table><p><span style=\"color: #000000;\">Gem\u00e4\u00df den neuesten Vorschriften ist die klinische Datenerhebung nun eine <em>unabdingbare Voraussetzung<\/em> f\u00fcr die Zulassung von Medizinprodukten. Dar\u00fcber hinaus m\u00fcssen Hersteller vor der Markteinf\u00fchrung ihrer Produkte <strong>systematische Risikoanalysen und Leistungsdaten<\/strong> vorlegen. Im Rahmen der Studie wird dies als <strong>vorl\u00e4ufige Unsicherheit<\/strong> bei noch nicht weit verbreiteten Technologien wie Biomaterialien interpretiert.<\/span><\/p><h3><span style=\"color: #000000;\"><strong>Barriers to clinical implementation<\/strong><\/span><\/h3><p><span style=\"color: #000000;\">Upon closer examination of the study, it becomes clear that clinical implementation is confronted with some barriers and that clear solutions need to be found in this regard. These can be summarized as follows:<\/span><\/p><ol><li><span style=\"color: #000000;\"><strong> Lack of data standardization<\/strong><\/span><\/li><\/ol><p><span style=\"color: #000000;\">The authors emphasize that the existing research data do not meet the MDR criteria:<\/span><\/p><ul><li><span style=\"color: #000000;\">Incompatibility between preclinical animal models and clinical results in humans<\/span><\/li><li><span style=\"color: #000000;\">Lack of common protocols for data exchange<\/span><\/li><\/ul><blockquote><p><span style=\"color: #000000;\"><em>\u201eMost studies on biomaterials do not correspond to the prescribed data formats, and the preclinical data are very fragmented.\u201c<\/em><\/span><\/p><p><span style=\"color: #000000;\">\u2014 <strong>Jurczak et al., 2024<\/strong><\/span><\/p><\/blockquote><ol start=\"2\"><li><span style=\"color: #000000;\"><strong> Differences in implementation between member states<\/strong><\/span><\/li><\/ol><p><span style=\"color: #000000;\">As mentioned in the article:<\/span><\/p><ul><li><span style=\"color: #000000;\">Local differences in risk classification complicate the CE certification process.<\/span><\/li><li><span style=\"color: #000000;\">A product classified as suitable in one country may be assigned a stricter class in another country.<\/span><\/li><\/ul><ol start=\"3\"><li><span style=\"color: #000000;\"><strong> Innovation barriers for small businesses<\/strong><\/span><\/li><\/ol><ul><li><span style=\"color: #000000;\">High regulatory costs have a deterrent effect on start-ups.<\/span><\/li><li><span style=\"color: #000000;\">In particular, the not yet completed standardization of new and composite biomaterials represents an uncertainty.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">What solutions are proposed in this area?<\/span><\/p><h3><span style=\"color: #000000;\"><strong>Proposed solutions: What is recommended<\/strong><\/span><\/h3><ol><li><span style=\"color: #000000;\"><strong> Safe-by-design approach<\/strong><\/span><\/li><\/ol><p><span style=\"color: #000000;\">According to Jurczak and colleagues, product safety must come first:<\/span><\/p><ul><li><span style=\"color: #000000;\">Biocompatibility and risk analysis must be promoted in parallel in the design process.<\/span><\/li><li><span style=\"color: #000000;\">Clinical application scenarios must be simulated in product development.<\/span><\/li><\/ul><ol start=\"2\"><li><span style=\"color: #000000;\"><strong> Early involvement of stakeholders<\/strong><\/span><\/li><\/ol><ul><li><span style=\"color: #000000;\">Clinicians, engineers, regulators and investors must come together in the same process.<\/span><\/li><li><span style=\"color: #000000;\">In this way, clinical benefits, technical design and legal conformity can be jointly optimized.<\/span><\/li><\/ul><ol start=\"3\"><li><span style=\"color: #000000;\"><strong> Data-based decision-making mechanisms<\/strong><\/span><\/li><\/ol><ul><li><span style=\"color: #000000;\">Clinical study protocols should be determined in advance in accordance with regulatory authorities' expectations.<\/span><\/li><li><span style=\"color: #000000;\">Instead of a \u201cunit solution\u201d, specific data strategies should be developed for each device class.<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><strong>Sources<\/strong><\/span><\/p><ul><li><span style=\"color: #000000;\">Jurczak, B., Dankers, P.Y.W., Blokzijl, M.M., &amp; Van Rijn, C.J.M. (2024). Recent regulatory developments in EU medical device regulation and their implications for the clinical translation of biomaterials. Bioengineering &amp; Translational Medicine, E10721. https:\/\/doi.org\/10.1002\/btm2.10721<\/span><\/li><li><span style=\"color: #000000;\">MDR 2017\/745 &amp; IVDR 2017\/746: <a href=\"https:\/\/eur-lex.europa.eu\/\">eur-lex.europa.eu<\/a><\/span><\/li><li><span style=\"color: #000000;\">European Commission: <a href=\"https:\/\/health.ec.europa.eu\/index_en\">health.ec.europa.eu<\/a><\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Mit den 2021 in Kraft getretenen Verordnungen MDR (2017\/745) und IVDR (2017\/746) wurden die Sicherheits- und Transparenzkriterien f\u00fcr Medizinprodukte durch die Europ\u00e4ische Union erheblich versch\u00e4rft. Damit wurden f\u00fcr Forscher, die biomaterialbasierte Produkte entwickeln, eine Reihe neuer anspruchsvoller Bedingungen f\u00fcr den \u00dcbergang zur klinischen Anwendung eingef\u00fchrt. In diesem Artikel m\u00f6chten wir Ihnen einen \u00dcberblick \u00fcber die \u2026 <a href=\"https:\/\/nano-test.de\/en\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Wie wirken sich die neuen Vorschriften f\u00fcr Medizinprodukte in Europa auf die Entwicklung von Biomaterialien aus?\u201c&gt;Continue reading <span class=\"screen-reader-text\">How do the new regulations for medical devices in Europe affect the development of biomaterials?<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":3316,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3315","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medizinprodukt-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Wie sich neue Vorschriften f\u00fcr Medizinprodukte in Europa auf die Entwicklung von Biomaterialien auswirken | nano-test.de<\/title>\n<meta name=\"description\" content=\"Erfahren Sie, wie die neuen EU-Medizinprodukteverordnungen (MDR und IVDR) die Entwicklung von Biomaterialien beeinflussen.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Wie sich neue Vorschriften f\u00fcr Medizinprodukte in Europa auf die Entwicklung von Biomaterialien auswirken | nano-test.de\" \/>\n<meta property=\"og:description\" content=\"Erfahren Sie, wie die neuen EU-Medizinprodukteverordnungen (MDR und IVDR) die Entwicklung von Biomaterialien beeinflussen.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/\" \/>\n<meta property=\"og:site_name\" content=\"Nano-Test\u00ae\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-04T20:04:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-08-04T20:23:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png\" \/>\n\t<meta property=\"og:image:width\" content=\"750\" \/>\n\t<meta property=\"og:image:height\" content=\"450\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Sultan Culum\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sultan Culum\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/\"},\"author\":{\"name\":\"Sultan Culum\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#\\\/schema\\\/person\\\/e873a4aee4023b424d94f10e41a12670\"},\"headline\":\"Wie wirken sich die neuen Vorschriften f\u00fcr Medizinprodukte in Europa auf die Entwicklung von Biomaterialien aus?\",\"datePublished\":\"2025-08-04T20:04:49+00:00\",\"dateModified\":\"2025-08-04T20:23:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/\"},\"wordCount\":566,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png\",\"articleSection\":[\"Medizinprodukt\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/\",\"url\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/\",\"name\":\"Wie sich neue Vorschriften f\u00fcr Medizinprodukte in Europa auf die Entwicklung von Biomaterialien auswirken | nano-test.de\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png\",\"datePublished\":\"2025-08-04T20:04:49+00:00\",\"dateModified\":\"2025-08-04T20:23:52+00:00\",\"description\":\"Erfahren Sie, wie die neuen EU-Medizinprodukteverordnungen (MDR und IVDR) die Entwicklung von Biomaterialien beeinflussen.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/#primaryimage\",\"url\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png\",\"contentUrl\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png\",\"width\":750,\"height\":450,\"caption\":\"Nano-Test.de erkl\u00e4rt, wie die neuen Vorschriften f\u00fcr Medizinprodukte in Europa die Entwicklung von Biomaterialien beeinflussen, insbesondere im Hinblick auf Sicherheitsbewertung, Risikomanagement und regulatorische Anforderungen\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/2025\\\/08\\\/04\\\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/nano-test.de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Wie wirken sich die neuen Vorschriften f\u00fcr Medizinprodukte in Europa auf die Entwicklung von Biomaterialien aus?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#website\",\"url\":\"https:\\\/\\\/nano-test.de\\\/\",\"name\":\"NANO-TEST\u00ae\",\"description\":\"Laboranalysen, Testservices, Pr\u00fcflabor &amp; Qualit\u00e4tskontrollen in Deutschland\",\"publisher\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/nano-test.de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#organization\",\"name\":\"NANO-TEST\u00ae\",\"url\":\"https:\\\/\\\/nano-test.de\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/Nanotest-Logo-NT-scaled.png\",\"contentUrl\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/Nanotest-Logo-NT-scaled.png\",\"width\":2510,\"height\":2560,\"caption\":\"NANO-TEST\u00ae\"},\"image\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#\\\/schema\\\/person\\\/e873a4aee4023b424d94f10e41a12670\",\"name\":\"Sultan Culum\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g\",\"caption\":\"Sultan Culum\"},\"sameAs\":[\"https:\\\/\\\/nano-test.de\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"How new medical device regulations in Europe affect the development of biomaterials | nano-test.de","description":"Find out how the new EU Medical Device Regulations (MDR and IVDR) influence the development of biomaterials.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/","og_locale":"en_US","og_type":"article","og_title":"Wie sich neue Vorschriften f\u00fcr Medizinprodukte in Europa auf die Entwicklung von Biomaterialien auswirken | nano-test.de","og_description":"Erfahren Sie, wie die neuen EU-Medizinprodukteverordnungen (MDR und IVDR) die Entwicklung von Biomaterialien beeinflussen.","og_url":"https:\/\/nano-test.de\/en\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/","og_site_name":"Nano-Test\u00ae","article_published_time":"2025-08-04T20:04:49+00:00","article_modified_time":"2025-08-04T20:23:52+00:00","og_image":[{"width":750,"height":450,"url":"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png","type":"image\/png"}],"author":"Sultan Culum","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Sultan Culum","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/#article","isPartOf":{"@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/"},"author":{"name":"Sultan Culum","@id":"https:\/\/nano-test.de\/#\/schema\/person\/e873a4aee4023b424d94f10e41a12670"},"headline":"Wie wirken sich die neuen Vorschriften f\u00fcr Medizinprodukte in Europa auf die Entwicklung von Biomaterialien aus?","datePublished":"2025-08-04T20:04:49+00:00","dateModified":"2025-08-04T20:23:52+00:00","mainEntityOfPage":{"@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/"},"wordCount":566,"commentCount":0,"publisher":{"@id":"https:\/\/nano-test.de\/#organization"},"image":{"@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/#primaryimage"},"thumbnailUrl":"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png","articleSection":["Medizinprodukt"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/","url":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/","name":"How new medical device regulations in Europe affect the development of biomaterials | nano-test.de","isPartOf":{"@id":"https:\/\/nano-test.de\/#website"},"primaryImageOfPage":{"@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/#primaryimage"},"image":{"@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/#primaryimage"},"thumbnailUrl":"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png","datePublished":"2025-08-04T20:04:49+00:00","dateModified":"2025-08-04T20:23:52+00:00","description":"Find out how the new EU Medical Device Regulations (MDR and IVDR) influence the development of biomaterials.","breadcrumb":{"@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/#primaryimage","url":"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png","contentUrl":"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Wie-wirken-sich-die-neuen-Vorschriften-fur-Medizinprodukte-in-Europa-auf-die-Entwicklung-von-Biomaterialien-aus.png","width":750,"height":450,"caption":"Nano-test.de explains how the new medical device regulations in Europe affect the development of biomaterials, especially with regard to safety assessment, risk management and regulatory requirements"},{"@type":"BreadcrumbList","@id":"https:\/\/nano-test.de\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/nano-test.de\/"},{"@type":"ListItem","position":2,"name":"How do the new regulations for medical devices in Europe affect the development of biomaterials?"}]},{"@type":"WebSite","@id":"https:\/\/nano-test.de\/#website","url":"https:\/\/nano-test.de\/","name":"NANO-TEST\u00ae","description":"Laboratory analyses, testing services, testing laboratories and quality control in Germany","publisher":{"@id":"https:\/\/nano-test.de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/nano-test.de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/nano-test.de\/#organization","name":"NANO-TEST\u00ae","url":"https:\/\/nano-test.de\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/nano-test.de\/#\/schema\/logo\/image\/","url":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/03\/Nanotest-Logo-NT-scaled.png","contentUrl":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/03\/Nanotest-Logo-NT-scaled.png","width":2510,"height":2560,"caption":"NANO-TEST\u00ae"},"image":{"@id":"https:\/\/nano-test.de\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/nano-test.de\/#\/schema\/person\/e873a4aee4023b424d94f10e41a12670","name":"Sultan Culum","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g","caption":"Sultan Culum"},"sameAs":["https:\/\/nano-test.de"]}]}},"_links":{"self":[{"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/posts\/3315","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/comments?post=3315"}],"version-history":[{"count":0,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/posts\/3315\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/media\/3316"}],"wp:attachment":[{"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/media?parent=3315"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/categories?post=3315"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/tags?post=3315"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}