{"id":6835,"date":"2022-02-09T09:42:46","date_gmt":"2022-02-09T09:42:46","guid":{"rendered":"https:\/\/r-biopharm.com\/?p=6835"},"modified":"2022-06-15T10:32:30","modified_gmt":"2022-06-15T10:32:30","slug":"priorita-assoluta-in-r-biopharm-livdr","status":"publish","type":"post","link":"https:\/\/r-biopharm.com\/it\/priorita-assoluta-in-r-biopharm-livdr\/","title":{"rendered":"Priorit\u00e0 assoluta in R-Biopharm: l\u2019IVDR"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_single_image image=&#8221;6702&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=&#8221;.vc_custom_1644583588939{margin-bottom: 0px !important;}&#8221;]L\u2019Ue ha creato un nuovo quadro giuridico per la qualit\u00e0 e la sicurezza dei dispositivi medici in vitro, ovvero l\u2019IVDR (regolamento relativo ai dispositivi medico-diagnostici in vitro), che fissa standard pi\u00f9 elevati, giuridicamente vincolanti per tutti gli Stati membri dell\u2019Ue a partire da maggio 2022. Innanzi tutto, questa ordinanza migliora la sicurezza clinica dei dispositivi medico-diagnostici in vitro e definisce una base giuridica uniforme per tutti i fabbricanti.<\/p>\n<p>Gli elementi chiave del nuovo regolamento sono requisiti pi\u00f9 severi per documentazione, evidenze cliniche e valutazione della conformit\u00e0, nonch\u00e9 trasparenza e tracciabilit\u00e0 dopo il lancio dei prodotti sul mercato. Con questa certificazione, i fabbricanti dimostrano di soddisfare i massimi standard di qualit\u00e0 e sicurezza e di disporre di un efficace sistema di gestione del rischio.[\/vc_column_text][vc_single_image image=&#8221;6856&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;link_image&#8221;][vc_column_text css=&#8221;.vc_custom_1646733024144{margin-bottom: 0px !important;}&#8221;]Essendo da sempre fortemente impegnata per la qualit\u00e0, R-Biopharm dichiara di garantire la piena osservanza delle disposizioni dell\u2019IVDR e impiega notevoli risorse per monitorare la piena attuazione di detto regolamento. Il nostro sistema completo di gestione della qualit\u00e0 ci consente di assicurare il rispetto degli standard e dei requisiti normativi, nonch\u00e9 l&#8217;applicazione di standard di qualit\u00e0 adeguatamente elevati, dallo sviluppo dei prodotti al loro utilizzo. In questo modo garantiamo un costante miglioramento della qualit\u00e0 al fine di fornire prodotti affidabili e di alta qualit\u00e0 sul lungo periodo per la salute di consumatori e pazienti.<\/p>\n<p>R-Biopharm continuer\u00e0 a fare fede a questo suo impegno, determinata ad affrontare le sfide future, come sancito dai valori fondamentali della nostra azienda. Naturalmente, verranno prorogati i periodi di transizione: le innovazioni dei prodotti devono essere conformi ai nuovi regolamenti dal 26 maggio 2022, mentre per i prodotti esistenti di diverse classi, tale requisito sar\u00e0 richiesto soltanto a partire da fine maggio 2025 (per i prodotti in classe D), 2026 (classe C) e 2027 (classi A-sterile e B). Nonostante ci\u00f2, l\u2019attuazione dei requisiti dell\u2019IVDR continua ad essere una priorit\u00e0 assoluta in R-Biopharm.[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_single_image image=&#8221;6702&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=&#8221;.vc_custom_1644583588939{margin-bottom: 0px !important;}&#8221;]L\u2019Ue ha creato un nuovo quadro giuridico per la qualit\u00e0 e la sicurezza dei dispositivi medici in vitro, ovvero l\u2019IVDR (regolamento relativo ai dispositivi medico-diagnostici in vitro), che fissa standard pi\u00f9 elevati, giuridicamente vincolanti per tutti gli Stati membri dell\u2019Ue a partire da maggio 2022. Innanzi tutto, questa ordinanza [&hellip;]<\/p>\n","protected":false},"author":1114,"featured_media":6711,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[363],"tags":[],"class_list":["post-6835","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-archivio-notizie"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Priorit\u00e0 assoluta in R-Biopharm: l\u2019IVDR - R-Biopharm AG<\/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:\/\/r-biopharm.com\/it\/priorita-assoluta-in-r-biopharm-livdr\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Priorit\u00e0 assoluta in R-Biopharm: l\u2019IVDR - R-Biopharm AG\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_single_image image=&#8221;6702&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=&#8221;.vc_custom_1644583588939{margin-bottom: 0px !important;}&#8221;]L\u2019Ue ha creato un nuovo quadro giuridico per la qualit\u00e0 e la sicurezza dei dispositivi medici in vitro, ovvero l\u2019IVDR (regolamento relativo ai dispositivi medico-diagnostici in vitro), che fissa standard pi\u00f9 elevati, giuridicamente vincolanti per tutti gli Stati membri dell\u2019Ue a partire da maggio 2022. 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