{"id":10804,"date":"2025-07-04T08:00:55","date_gmt":"2025-07-04T08:00:55","guid":{"rendered":"https:\/\/osapiens.com\/fr\/?p=10804"},"modified":"2025-07-04T08:04:55","modified_gmt":"2025-07-04T08:04:55","slug":"conformite-udi-evolutive","status":"publish","type":"post","link":"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/","title":{"rendered":"EUDAMED n\u2019est qu\u2019un d\u00e9but : comment garantir la conformit\u00e9 UDI \u00e0 l\u2019\u00e9chelle mondiale ?"},"content":{"rendered":"\n<p>EUDAMED transforme le paysage r\u00e9glementaire europ\u00e9en. Mais elle n\u2019est que l\u2019un des nombreux syst\u00e8mes en cours de d\u00e9ploiement \u00e0 travers le monde. Les autorit\u00e9s sanitaires internationales lancent leurs propres bases UDI, chacune avec ses formats de donn\u00e9es, calendriers et exigences techniques sp\u00e9cifiques.<\/p>\n\n\n\n<p>Aujourd\u2019hui, les fabricants de dispositifs m\u00e9dicaux doivent d\u00e9j\u00e0 se conformer \u00e0 des bases telles que la GUDID (FDA, \u00c9tats-Unis), la NMPA (Chine) ou la MFDS (Cor\u00e9e du Sud). Et bient\u00f4t, d\u2019autres syst\u00e8mes comme Swissdamed (Suisse), la TGA (Australie), l\u2019ANVISA (Br\u00e9sil) et la MHRA (Royaume-Uni) viendront \u00e9toffer cet \u00e9cosyst\u00e8me. Le cadre r\u00e9glementaire mondial devient \u00e0 la fois plus fragment\u00e9 et plus exigeant.<\/p>\n\n\n\n<p>Pour rester comp\u00e9titifs, les fabricants doivent d\u00e9passer une approche locale ou r\u00e9gionale et adopter une strat\u00e9gie UDI globale, coh\u00e9rente et \u00e9volutive. Car EUDAMED n\u2019est qu\u2019une \u00e9tape dans une transformation r\u00e9glementaire de grande ampleur.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-la-conformite-mondiale-repose-sur-des-donnees-produit-unifiees\"><strong><strong><strong>La conformit\u00e9 mondiale repose sur des donn\u00e9es produit unifi\u00e9es<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>Les autorit\u00e9s r\u00e9glementaires ne sont plus les seules \u00e0 exiger des donn\u00e9es fiables. H\u00f4pitaux, centrales d\u2019achat, partenaires logistiques ou encore auditeurs ESG attendent tous des informations produit pr\u00e9cises, coh\u00e9rentes et synchronis\u00e9es \u2014 quel que soit le syst\u00e8me utilis\u00e9 ou la r\u00e9gion concern\u00e9e.<\/p>\n\n\n\n<p>Les fabricants ont besoin d\u2019une source unique de v\u00e9rit\u00e9 qui comprenne :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Des bases de donn\u00e9es r\u00e9glementaires telles que EUDAMED, GUDID et autres<\/li>\n\n\n\n<li>Des op\u00e9rations commerciales et des r\u00e9seaux de partenaires<\/li>\n\n\n\n<li>Exigences ESG et de durabilit\u00e9<\/li>\n\n\n\n<li>Tra\u00e7abilit\u00e9 de la cha\u00eene d&rsquo;approvisionnement<\/li>\n<\/ul>\n\n\n\n<p>L\u2019alignement du contenu UDI sur les standards GS1, combin\u00e9 \u00e0 l\u2019utilisation du Global Data Synchronization Network (GDSN), permet de garantir l\u2019int\u00e9grit\u00e9 des donn\u00e9es \u00e0 l\u2019\u00e9chelle mondiale. R\u00e9sultat : compatibilit\u00e9 renforc\u00e9e entre les syst\u00e8mes, r\u00e9duction des interventions manuelles, et mise \u00e0 jour des donn\u00e9es en temps r\u00e9el sur l\u2019ensemble des canaux.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-anticipez-la-suite-le-module-vigilance-arrive-a-grands-pas\"><strong><strong><strong>Anticipez la suite : le module Vigilance arrive \u00e0 grands pas<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>Le prochain grand volet d\u2019EUDAMED \u2014 d\u00e9di\u00e9 \u00e0 la vigilance et \u00e0 la surveillance post-commercialisation \u2014 sera lanc\u00e9 en 2026. Contrairement aux modules pr\u00e9c\u00e9dents, son d\u00e9ploiement suivra un mod\u00e8le \u00ab big bang \u00bb : il deviendra obligatoire d\u00e8s son activation.<\/p>\n\n\n\n<p>Les fabricants doivent donc anticiper d\u00e8s 2025 les tests de ce module, en parall\u00e8le de la finalisation de leur conformit\u00e9 UDI. L\u2019enjeu : mettre en place un pipeline de donn\u00e9es unifi\u00e9, capable de supporter \u00e0 la fois les modules existants et ceux \u00e0 venir, avec un minimum d\u2019ajustements. Ce socle commun garantit une adaptation fluide aux exigences r\u00e9glementaires en constante \u00e9volution.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-construire-pour-l-evolutivite-pas-seulement-pour-la-conformite\"><strong><strong><strong>Construire pour l\u2019\u00e9volutivit\u00e9 \u2014 pas seulement pour la conformit\u00e9<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>Chez BYRD Health, nous aidons les fabricants de dispositifs m\u00e9dicaux \u00e0 d\u00e9passer les objectifs de conformit\u00e9 imm\u00e9diats pour construire des \u00e9cosyst\u00e8mes UDI durables et \u00e9volutifs. Nos solutions sont pens\u00e9es pour r\u00e9pondre aux enjeux actuels et futurs, en int\u00e9grant :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>La soumission r\u00e9glementaire,<\/li>\n\n\n\n<li>La gestion du contenu produit \u00e0 des fins commerciales,<\/li>\n\n\n\n<li>L\u2019optimisation des flux logistiques,<\/li>\n\n\n\n<li>Et les obligations de reporting ESG.<\/li>\n<\/ul>\n\n\n\n<p>En collaborant \u00e9troitement avec un r\u00e9seau de fabricants, de fournisseurs de technologies et d\u2019autorit\u00e9s r\u00e9glementaires, nous permettons \u00e0 nos clients de rester en phase avec les standards du secteur et de se pr\u00e9parer aux \u00e9volutions r\u00e9glementaires \u00e0 venir.tory bodies, we help clients stay aligned with industry standards \u2013 and ahead of upcoming changes.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-voir-plus-loin-que-la-prochaine-echeance\"><strong><strong><strong>Voir plus loin que la prochaine \u00e9ch\u00e9ance<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>Les r\u00e9glementations continueront d\u2019\u00e9voluer. EUDAMED repr\u00e9sente une \u00e9tape cl\u00e9, mais ce n\u2019est qu\u2019un d\u00e9but. La v\u00e9ritable opportunit\u00e9 r\u00e9side dans la mise en place d\u2019une infrastructure de donn\u00e9es p\u00e9renne \u2014 capable de relier conformit\u00e9, performance op\u00e9rationnelle et cr\u00e9ation de valeur.<\/p>\n\n\n\n<p>Chez <a href=\"https:\/\/osapiens.com\/fr\/solutions\/medical-devices-byrd\/\" target=\"_blank\" rel=\"noreferrer noopener\">BYRD Health<\/a>, nous accompagnons les fabricants \u00e0 chaque \u00e9tape de leur mise en conformit\u00e9 avec EUDAMED : de la conception de sc\u00e9narios de test personnalis\u00e9s \u00e0 la validation finale. Nos experts optimisent les flux de donn\u00e9es, s\u00e9curisent votre pr\u00e9paration et vous aident \u00e0 garder une longueur d\u2019avance. Avec l\u2019\u00e9ch\u00e9ance de 2026 qui se rapproche, le moment d\u2019agir, c\u2019est maintenant : pour rester align\u00e9, \u00e9viter les \u00e9cueils, et tirer pleinement parti des opportunit\u00e9s du march\u00e9.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EUDAMED transforme le paysage r\u00e9glementaire europ\u00e9en. Mais elle n\u2019est que l\u2019un des nombreux syst\u00e8mes en cours de d\u00e9ploiement \u00e0 travers le monde. Les autorit\u00e9s sanitaires internationales lancent leurs propres bases UDI, chacune avec ses formats de donn\u00e9es, calendriers et exigences techniques sp\u00e9cifiques. Aujourd\u2019hui, les fabricants de dispositifs m\u00e9dicaux doivent d\u00e9j\u00e0 se conformer \u00e0 des bases telles que la GUDID (FDA, &#8230; <\/p>\n<div><a href=\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/\" class=\"more-link\">Read More<\/a><\/div>\n","protected":false},"author":46,"featured_media":10839,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17],"tags":[],"class_list":["post-10804","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.3 (Yoast SEO v24.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUDAMED n\u2019est qu\u2019un d\u00e9but : comment garantir la conformit\u00e9 UDI \u00e0 l\u2019\u00e9chelle mondiale ? | osapiens<\/title>\n<meta name=\"description\" content=\"EUDAMED n\u2019est qu\u2019un point de d\u00e9part : comment b\u00e2tir une strat\u00e9gie UDI globale, conforme aujourd\u2019hui et \u00e9volutive demain.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUDAMED n\u2019est qu\u2019un d\u00e9but : comment garantir la conformit\u00e9 UDI \u00e0 l\u2019\u00e9chelle mondiale ?\" \/>\n<meta property=\"og:description\" content=\"EUDAMED n\u2019est qu\u2019un point de d\u00e9part : comment b\u00e2tir une strat\u00e9gie UDI globale, conforme aujourd\u2019hui et \u00e9volutive demain.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/\" \/>\n<meta property=\"og:site_name\" content=\"osapiens.com\/fr\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-07-04T08:00:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-04T08:04:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/osapiens.com\/fr\/wp-content\/uploads\/sites\/4\/2025\/05\/EUDAMED-blogheader-03.png\" \/>\n\t<meta property=\"og:image:width\" content=\"640\" \/>\n\t<meta property=\"og:image:height\" content=\"360\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"osapiensyn\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@osapiens_\" \/>\n<meta name=\"twitter:site\" content=\"@osapiens_\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"osapiensyn\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/\"},\"author\":{\"name\":\"osapiensyn\",\"@id\":\"https:\/\/osapiens.com\/fr\/#\/schema\/person\/294e2e2c0ec0d557f276d74d6e18ec72\"},\"headline\":\"EUDAMED n\u2019est qu\u2019un d\u00e9but : comment garantir la conformit\u00e9 UDI \u00e0 l\u2019\u00e9chelle mondiale ?\",\"datePublished\":\"2025-07-04T08:00:55+00:00\",\"dateModified\":\"2025-07-04T08:04:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/\"},\"wordCount\":730,\"publisher\":{\"@id\":\"https:\/\/osapiens.com\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/osapiens.com\/fr\/wp-content\/uploads\/sites\/4\/2025\/05\/EUDAMED-blogheader-03.png\",\"articleSection\":[\"Blog\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/\",\"url\":\"https:\/\/osapiens.com\/fr\/blog\/conformite-udi-evolutive\/\",\"name\":\"EUDAMED n\u2019est qu\u2019un d\u00e9but : comment garantir la conformit\u00e9 UDI \u00e0 l\u2019\u00e9chelle mondiale ? 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