{"id":6820,"date":"2022-02-09T09:42:46","date_gmt":"2022-02-09T09:42:46","guid":{"rendered":"https:\/\/r-biopharm.com\/?p=6820"},"modified":"2022-06-15T10:25:09","modified_gmt":"2022-06-15T10:25:09","slug":"priorite-absolue-de-r-biopharm-livdr","status":"publish","type":"post","link":"https:\/\/r-biopharm.com\/fr\/priorite-absolue-de-r-biopharm-livdr\/","title":{"rendered":"Priorit\u00e9 absolue de R-Biopharm : l\u2019IVDR"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_single_image image=\u00a0\u00bb6702&Prime; img_size=\u00a0\u00bbfull\u00a0\u00bb alignment=\u00a0\u00bbcenter\u00a0\u00bb][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=\u00a0\u00bb.vc_custom_1644582458599{margin-bottom: 0px !important;}\u00a0\u00bb]L\u2019UE a cr\u00e9\u00e9 un nouveau cadre juridique pour la qualit\u00e9 et la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux in vitro, \u00e0 savoir l&rsquo;IVDR (r\u00e8glement relatif aux dispositifs m\u00e9dicaux de diagnostic in vitro), qui fixe des normes juridiquement contraignantes plus strictes pour tous les \u00c9tats membres de l\u2019UE \u00e0 partir de mai 2022. Avant tout, cette ordonnance am\u00e9liore la s\u00e9curit\u00e9 clinique des dispositifs m\u00e9dicaux de diagnostic in vitro et \u00e9tablit une base juridique uniforme pour tous les fabricants.<\/p>\n<p>Les \u00e9l\u00e9ments cl\u00e9s du nouveau r\u00e8glement sont des exigences plus strictes en mati\u00e8re de documentation, de preuves cliniques et d\u2019\u00e9valuation de la conformit\u00e9, ainsi que la transparence et la tra\u00e7abilit\u00e9 apr\u00e8s la mise sur le march\u00e9 des produits. Avec cette certification, les fabricants montrent qu\u2019ils respectent les normes de qualit\u00e9 et de s\u00e9curit\u00e9 les plus exigeantes et qu\u2019ils ont mis en place un syst\u00e8me efficace de gestion des risques.[\/vc_column_text][vc_single_image image=\u00a0\u00bb6824&Prime; img_size=\u00a0\u00bbfull\u00a0\u00bb alignment=\u00a0\u00bbcenter\u00a0\u00bb onclick=\u00a0\u00bblink_image\u00a0\u00bb][vc_column_text css=\u00a0\u00bb.vc_custom_1646732991106{margin-bottom: 0px !important;}\u00a0\u00bb]\u00c9tant donn\u00e9 que la qualit\u00e9 a toujours fait partie de ses engagements fermes, R-Biopharm affirme respecter \u00e0 100\u00a0% les dispositions de l\u2019IVDR et emploie des moyens consid\u00e9rables pour surveiller la mise en \u0153uvre int\u00e9grale de cette r\u00e9glementation. Notre syst\u00e8me complet de gestion de la qualit\u00e9 nous permet d\u2019assurer le respect des normes et des exigences r\u00e9glementaires, ainsi que l\u2019application des normes de qualit\u00e9 appropri\u00e9es, du d\u00e9veloppement des produits jusqu\u2019\u00e0 leur utilisation. De cette fa\u00e7on, nous garantissons une constante am\u00e9lioration de la qualit\u00e9 afin de fournir des produits fiables et de grande qualit\u00e9 sur le long terme pour la sant\u00e9 des consommateurs et des patients.<\/p>\n<p>R-Biopharm continuera \u00e0 adopter un comportement ferme dans ce but avec la volont\u00e9 de relever les d\u00e9fis futurs, l\u2019une des valeurs fondamentales de notre entreprise. Bien s\u00fbr, les p\u00e9riodes de transition ont \u00e9t\u00e9 prolong\u00e9es &#8211; les innovations de produits doivent \u00eatre conformes au nouveau r\u00e8glement \u00e0 partir du 26 mai 2022, m\u00eame si pour les produits existants des diff\u00e9rentes classes, cela ne s\u2019appliquera qu\u2019\u00e0 partir de fin mai 2025 (pour les produits de classe D), 2026 (classe C) et 2027 (classes A-st\u00e9rile et B). Malgr\u00e9 cela, la mise en \u0153uvre des exigences de l&rsquo;IVDR continue d&rsquo;\u00eatre une priorit\u00e9 absolue chez R-Biopharm.[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_single_image image=\u00a0\u00bb6702&Prime; img_size=\u00a0\u00bbfull\u00a0\u00bb alignment=\u00a0\u00bbcenter\u00a0\u00bb][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=\u00a0\u00bb.vc_custom_1644582458599{margin-bottom: 0px !important;}\u00a0\u00bb]L\u2019UE a cr\u00e9\u00e9 un nouveau cadre juridique pour la qualit\u00e9 et la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux in vitro, \u00e0 savoir l&rsquo;IVDR (r\u00e8glement relatif aux dispositifs m\u00e9dicaux de diagnostic in vitro), qui fixe des normes juridiquement contraignantes plus strictes pour tous les \u00c9tats membres de l\u2019UE \u00e0 partir de mai [&hellip;]<\/p>\n","protected":false},"author":1114,"featured_media":6710,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[362],"tags":[],"class_list":["post-6820","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-archives-des-actualites"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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