{"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\/it\/2025\/08\/04\/wie-wirken-sich-die-neuen-vorschriften-fur-medizinprodukte-in-europa-auf-die-entwicklung-von-biomaterialien-aus\/","title":{"rendered":"In che modo le nuove normative per i dispositivi medici in Europa stanno influenzando lo sviluppo dei biomateriali?"},"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> e <strong>IVDR (2017\/746)<\/strong> wurden die Sicherheits- und Transparenzkriterien f\u00fcr <a href=\"https:\/\/nano-test.de\/it\/service\/medizinprodukt\/\">Dispositivi medici<\/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 questo articolo, vorremmo darvi una panoramica degli \"Impatti del regolamento sui dispositivi medici sullo sviluppo dei biomateriali\" sulla base dei risultati di uno pubblicato da Jurczak e colleghi nel 2024 sulla rivista Bioengineering &amp; Translational Medicine Scientific Study.<\/span><\/p><blockquote><p><span style=\"color: #000000;\"><em>\"Le nuove normative portano non solo gli obblighi di conformit\u00e0, ma anche i cambiamenti strutturali nella sicurezza clinica e nella standardizzazione dei dati\".<\/em><\/span><\/p><p><span style=\"color: #000000;\">\u2014 <strong>Jurczak et al., 2024<\/strong><\/span><\/p><\/blockquote><p><span style=\"color: #000000;\"><strong>Prima di entrare pi\u00f9 nel dettaglio, prima conosciamo i termini MDR e IVDR.<\/strong><\/span><\/p><h3><span style=\"color: #000000;\"><strong>Cosa sono MDR e IVDR in breve?<\/strong><\/span><\/h3><table width=\"670\"><thead><tr><td><strong><span style=\"color: #000000;\">Criterio<\/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;\">Portata<\/span><\/td><td><span style=\"color: #000000;\">Tutti i dispositivi medici<\/span><\/td><td><span style=\"color: #000000;\">Diagnostica in vitro<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\">Innovazione<\/span><\/td><td><span style=\"color: #000000;\">Valutazione clinica, sistema UDI<\/span><\/td><td><span style=\"color: #000000;\">Prova di prestazione, riclassifica<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\">Obbiettivo<\/span><\/td><td><span style=\"color: #000000;\">Migliorare la sicurezza del paziente<\/span><\/td><td><span style=\"color: #000000;\">Garantire l'accuratezza diagnostica e la tracciabilit\u00e0<\/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>Ostacoli all'implementazione clinica<\/strong><\/span><\/h3><p><span style=\"color: #000000;\">A un esame pi\u00f9 attento dello studio, diventa chiaro che l'implementazione clinica deve affrontare alcuni ostacoli e che al riguardo devono essere trovate soluzioni chiare. Questi possono essere cos\u00ec riassunti:<\/span><\/p><ol><li><span style=\"color: #000000;\"><strong> Mancanza di standardizzazione dei dati<\/strong><\/span><\/li><\/ol><p><span style=\"color: #000000;\">Gli autori sottolineano che i dati di ricerca esistenti non soddisfano i criteri MDR:<\/span><\/p><ul><li><span style=\"color: #000000;\">Incompatibilit\u00e0 tra modelli animali preclinici e risultati clinici nell'uomo<\/span><\/li><li><span style=\"color: #000000;\">Mancanza di protocolli comuni di scambio dati<\/span><\/li><\/ul><blockquote><p><span style=\"color: #000000;\"><em>\"La maggior parte degli studi sui biomateriali non \u00e8 conforme ai formati di dati prescritti e i dati preclinici sono molto frammentati\".<\/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> Differenze nell'attuazione tra gli Stati membri<\/strong><\/span><\/li><\/ol><p><span style=\"color: #000000;\">Come accennato nell'articolo:<\/span><\/p><ul><li><span style=\"color: #000000;\">Le differenze locali nella classificazione del rischio rendono difficile il processo di certificazione CE.<\/span><\/li><li><span style=\"color: #000000;\">Un prodotto classificato come idoneo in un paese pu\u00f2 essere assegnato a una classe pi\u00f9 rigorosa in un altro paese.<\/span><\/li><\/ul><ol start=\"3\"><li><span style=\"color: #000000;\"><strong> Barriere all'innovazione per le piccole imprese<\/strong><\/span><\/li><\/ol><ul><li><span style=\"color: #000000;\">Gli elevati costi regolatori hanno un effetto deterrente sulle start-up.<\/span><\/li><li><span style=\"color: #000000;\">In particolare, la standardizzazione di biomateriali nuovi e compositi non ancora completati rappresenta un'incertezza.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Quali soluzioni ci sono in questo settore?<\/span><\/p><h3><span style=\"color: #000000;\"><strong>Soluzioni suggerite: cosa \u00e8 consigliato?<\/strong><\/span><\/h3><ol><li><span style=\"color: #000000;\"><strong> Approccio alla progettazione sicura<\/strong><\/span><\/li><\/ol><p><span style=\"color: #000000;\">Secondo Jurczak e colleghi, la sicurezza del prodotto deve essere prima:<\/span><\/p><ul><li><span style=\"color: #000000;\">La biocompatibilit\u00e0 e l'analisi del rischio devono essere promosse parallelamente nel processo di progettazione.<\/span><\/li><li><span style=\"color: #000000;\">Gli scenari di applicazione clinica devono essere simulati nello sviluppo del prodotto.<\/span><\/li><\/ul><ol start=\"2\"><li><span style=\"color: #000000;\"><strong> Coinvolgimento precoce delle parti interessate<\/strong><\/span><\/li><\/ol><ul><li><span style=\"color: #000000;\">Clinici, ingegneri, regolatori e investitori devono riunirsi nello stesso processo.<\/span><\/li><li><span style=\"color: #000000;\">In questo modo, i vantaggi clinici, la progettazione tecnica e la conformit\u00e0 legale possono essere ottimizzati congiuntamente.<\/span><\/li><\/ul><ol start=\"3\"><li><span style=\"color: #000000;\"><strong> Meccanismi decisionali basati sui dati<\/strong><\/span><\/li><\/ol><ul><li><span style=\"color: #000000;\">I protocolli di studio clinico dovrebbero essere determinati in anticipo secondo le aspettative delle autorit\u00e0 di regolamentazione.<\/span><\/li><li><span style=\"color: #000000;\">Invece di una \"soluzione unit\", dovrebbero essere sviluppate strategie di dati specifiche per ogni classe di dispositivi.<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><strong>Fonti<\/strong><\/span><\/p><ul><li><span style=\"color: #000000;\">Jurczak, B., Dankers, PYW, Blokzijl, MM e van Rijn, CJ.M. (2024). Recenti sviluppi normativi nella regolamentazione dei dispositivi medici dell'UE e le loro implicazioni per la traduzione clinica dei biomateriali. Bioingegneria e medicina traslazionale, 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\/it\/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 &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\">In che modo le nuove normative per i dispositivi medici in Europa stanno influenzando lo sviluppo dei biomateriali?<\/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\" 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