{"id":9490,"date":"2026-02-16T17:21:56","date_gmt":"2026-02-16T09:21:56","guid":{"rendered":"https:\/\/regask.com\/?p=9490"},"modified":"2026-03-03T12:57:36","modified_gmt":"2026-03-03T04:57:36","slug":"la-commission-europeenne-publie-la-version-2-22-0-deudamed-qui-integre-des-mises-a-jour-obligatoires-concernant-lenregistrement-des-dispositifs-medicaux-applicables-a-compter-de-mai-2026","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/eu-commission-releases-eudamed-version-2-22-0-with-mandatory-medical-device-registration-updates-effective-may-2026\/","title":{"rendered":"La Commission europ\u00e9enne publie la version 2.22.0 d&#039;EUDAMED avec Mand\u2026"},"content":{"rendered":"<p>Sur <strong>5 janvier 2026<\/strong>, le<strong> Commission europ\u00e9enne<\/strong> a annonc\u00e9 la sortie de la production de <strong>EUDAMED version 2.22.0,<\/strong> introduction de mises \u00e0 jour syst\u00e8me obligatoires qui am\u00e9liorent <strong>Enregistrement des dispositifs m\u00e9dicaux et gestion des donn\u00e9es<\/strong> dans toute l&#039;Union europ\u00e9enne. La mise \u00e0 jour concerne <strong>fabricants, organismes notifi\u00e9s et autres acteurs du secteur des dispositifs m\u00e9dicaux,<\/strong> avec l&#039;utilisation obligatoire des quatre modules EUDAMED de base \u00e0 compter du <strong>28 mai 2026. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1359271474\">\n\n\t<div id=\"col-946336904\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1333392001\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1333392001 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-393866161\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-393866161 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La sortie de <strong>EUDAMED<\/strong> <strong>version 2.22.0<\/strong> renforce la tra\u00e7abilit\u00e9, l&#039;exactitude des donn\u00e9es et la facilit\u00e9 d&#039;utilisation dans les modules cl\u00e9s, notamment <strong>enregistrement des acteurs, identification des appareils (UDI), certificats,<\/strong> et <strong>acc\u00e8s \u00e0 l&#039;information publique.\u00a0<\/strong><\/p>\n<p>Pour l&#039;inscription des acteurs, <strong>\u201cDates de \u201d derni\u00e8re confirmation des donn\u00e9es \u00bb<\/strong> Les donn\u00e9es sont d\u00e9sormais affich\u00e9es par version, ce qui am\u00e9liore la transparence concernant l&#039;\u00e9tat de validation des donn\u00e9es pour tous les acteurs enregistr\u00e9s.<\/p>\n<p>Pour l&#039;enregistrement de l&#039;appareil, <strong>Gestion des versions du code EMDN<\/strong> a \u00e9t\u00e9 mis en \u0153uvre, et <strong>codes EMDN obsol\u00e8tes<\/strong> ont \u00e9t\u00e9 retir\u00e9es des listes de s\u00e9lection, garantissant ainsi que seule la nomenclature actuelle est utilis\u00e9e.<\/p>\n<p>Dans le module des certificats, <strong>Organismes notifi\u00e9s<\/strong> sont d\u00e9sormais autoris\u00e9s \u00e0 faire r\u00e9f\u00e9rence <strong>fabricants ou producteurs non enregistr\u00e9s de l&#039;UE<\/strong> lors de la d\u00e9livrance de certificats refus\u00e9s ou du traitement des demandes connexes, y compris <strong>appareils anciens.\u00a0<\/strong><\/p>\n<p>D&#039;un point de vue technique, <strong>Sch\u00e9ma XSD version 3.0.25<\/strong> est d\u00e9sormais obligatoire pour tous <strong>Demandes de service DTX,<\/strong> refl\u00e9tant les exigences mises \u00e0 jour en mati\u00e8re de documentation technique.<\/p>\n<p>La fonctionnalit\u00e9 de t\u00e9l\u00e9chargement en masse a \u00e9t\u00e9 am\u00e9lior\u00e9e pour permettre <strong>statuts de r\u00e9ussite partielle,<\/strong> soutenu par de nouveaux<strong> structures de r\u00e9ponse XML<\/strong> qui fournissent un retour d&#039;information au niveau de l&#039;objet.<\/p>\n<p>Sur le site public, les am\u00e9liorations d&#039;ergonomie comprennent <strong>options de pays \u00e9largies<\/strong> et <strong>filtres de rapport de synth\u00e8se am\u00e9lior\u00e9s,<\/strong> am\u00e9liorer l&#039;acc\u00e8s du public aux informations sur les dispositifs m\u00e9dicaux.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-946336904 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1663540140\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Calendrier de mise en application<\/h2>\n\t<div id=\"gap-905857136\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-905857136 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Utilisation obligatoire de <strong>quatre modules EUDAMED de base<\/strong>, l&#039;enregistrement des acteurs, l&#039;identification des appareils (UDI), les certificats et l&#039;acc\u00e8s aux informations publiques, <strong>entre en vigueur le 28 mai 2026. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1663540140 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1538519927\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Date d&#039;entr\u00e9e en vigueur<\/h2>\n\t<div id=\"gap-496405104\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-496405104 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Utilisation obligatoire de <strong>quatre modules EUDAMED de base,<\/strong> y compris <strong>enregistrement des acteurs, identification des appareils (UDI), certificats et acc\u00e8s aux informations publiques,<\/strong> prend effet le <strong>28 mai 2026.<\/strong> \u00c0 compter de cette date, les fabricants de dispositifs m\u00e9dicaux, les organismes notifi\u00e9s et les autres parties prenantes concern\u00e9es doivent se conformer aux exigences mises \u00e0 jour introduites en vertu de <strong>Version EUDAMED 2.22.0. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1538519927 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-223830268\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-217256260\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-217256260 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ces mises \u00e0 jour offrent une plus grande<strong> clart\u00e9 r\u00e9glementaire,<\/strong> aligner plus \u00e9troitement EUDAMED avec <strong>attentes en mati\u00e8re de gouvernance des donn\u00e9es num\u00e9riques,<\/strong> et am\u00e9liorer <strong>efficacit\u00e9 op\u00e9rationnelle<\/strong> Gr\u00e2ce \u00e0 une tra\u00e7abilit\u00e9 renforc\u00e9e et \u00e0 des \u00e9changes de donn\u00e9es structur\u00e9s, cette mise \u00e0 jour am\u00e9liore la conformit\u00e9 en optimisant les flux de travail et les normes techniques, tout en r\u00e9duisant au minimum les charges administratives pour les acteurs concern\u00e9s.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-223830268 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-573739413\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u00c0 qui cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-252789374\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-252789374 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est particuli\u00e8rement pertinente pour<strong> \u00c9quipes des affaires r\u00e9glementaires, de l&#039;assurance qualit\u00e9, des technologies de l&#039;information et de la gestion des donn\u00e9es,<\/strong> et <strong>Op\u00e9rations des organismes notifi\u00e9s<\/strong> impliqu\u00e9 dans l&#039;enregistrement, la certification et le suivi continu de la conformit\u00e9 des dispositifs m\u00e9dicaux au sein de l&#039;UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-573739413 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-979199245\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-927680694\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-927680694 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les parties prenantes devraient examiner les \u00e9l\u00e9ments existants <strong>processus de saisie de donn\u00e9es et d&#039;enregistrement des appareils<\/strong> Pour garantir la conformit\u00e9 avec la version 2.22.0 d&#039;EUDAMED, \u00e9valuer la compatibilit\u00e9 du syst\u00e8me avec <strong>Sch\u00e9ma XSD version 3.0.25,<\/strong> et se pr\u00e9parer aux changements \u00e0 <strong>S\u00e9lection du code EMDN, suivi de la date de confirmation, <\/strong>et<strong> r\u00e9ponses de t\u00e9l\u00e9chargement en masse<\/strong> avant la date d&#039;entr\u00e9e en vigueur pr\u00e9vue en mai 2026.<\/p>\n<p>Alors que les organisations \u00e9valuent leur pr\u00e9paration \u00e0 l&#039;utilisation obligatoire du module EUDAMED et \u00e0 l&#039;\u00e9volution des exigences en mati\u00e8re de donn\u00e9es, une visibilit\u00e9 pr\u00e9coce sur les changements du syst\u00e8me r\u00e9glementaire peut r\u00e9duire consid\u00e9rablement le risque de non-conformit\u00e9. <strong><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentielle<\/strong> qui permet aux organisations internationales op\u00e9rant dans des secteurs fortement r\u00e9glement\u00e9s, notamment les sciences de la vie, d&#039;anticiper et de g\u00e9rer des environnements r\u00e9glementaires complexes. En combinant une IA agentique avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes, <a href=\"https:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> Fournit des informations pr\u00e9dictives exploitables en temps opportun et une automatisation de bout en bout, aidant les \u00e9quipes \u00e0 suivre les mises \u00e0 jour d&#039;EUDAMED, \u00e0 \u00e9valuer l&#039;impact et \u00e0 rationaliser la pr\u00e9paration \u00e0 la conformit\u00e9 dans plus de 160 pays. <a href=\"https:\/\/regask.com\/fr\/\"><strong>En savoir plus<\/strong><\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"><strong>r\u00e9servez une d\u00e9mo maintenant.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-979199245 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1989163523\">\n\n\t<div id=\"col-1092654129\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQ<\/h3>\n\t<div id=\"gap-642731974\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-642731974 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Qu&#039;est-ce que la version 2.22.0 d&#039;EUDAMED\u00a0?<\/h4>\n\t<div id=\"gap-1937232048\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1937232048 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La version 2.22.0 d&#039;EUDAMED est une version de production qui introduit des mises \u00e0 jour obligatoires concernant la gestion des donn\u00e9es des dispositifs m\u00e9dicaux, la tra\u00e7abilit\u00e9 et les interfaces techniques au sein de l&#039;UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1092654129 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-135756363\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Quand l&#039;utilisation obligatoire des modules de base EUDAMED commencera-t-elle\u00a0?<\/h4>\n\t<div id=\"gap-805538544\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-805538544 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>L&#039;utilisation obligatoire des quatre modules EUDAMED de base commence le <strong>28 mai 2026.<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-135756363 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1626166039\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Quelles modifications ont \u00e9t\u00e9 apport\u00e9es aux codes EMDN dans cette mise \u00e0 jour\u00a0?<\/h4>\n\t<div id=\"gap-282926549\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-282926549 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La mise \u00e0 jour introduit <strong>Gestion des versions du code EMDN<\/strong> et supprime <strong>codes obsol\u00e8tes<\/strong> \u00e0 partir des s\u00e9lections d&#039;enregistrement de l&#039;appareil.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1626166039 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1621402342\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Comment RegASK peut-il aider les entreprises \u00e0 s&#039;adapter aux changements r\u00e9glementaires induits par l&#039;IA\u00a0?<\/h4>\n\t<div id=\"gap-447595868\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-447595868 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> Aide les organisations \u00e0 suivre les mises \u00e0 jour des autorit\u00e9s r\u00e9glementaires, \u00e0 \u00e9valuer l&#039;impact sur la conformit\u00e9 et \u00e0 adapter leurs flux de travail internes gr\u00e2ce \u00e0 une intelligence r\u00e9glementaire bas\u00e9e sur l&#039;IA et \u00e0 une automatisation guid\u00e9e par des experts.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1621402342 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 5 January 2026, the European Commission announced the production release of EUDAMED version 2.22.0, introducing mandatory system updates that enhance medical device registration and data management across the European Union. The update affects manufacturers, Notified Bodies, and other medical device stakeholders, with mandatory use of the four core EUDAMED modules beginning on 28 May&#8230;<\/p>","protected":false},"author":41,"featured_media":9491,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,538],"tags":[],"class_list":["post-9490","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-european-union"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU Commission Releases EUDAMED Version 2.22.0 Changes<\/title>\n<meta name=\"description\" content=\"Learn about the EU Commission&#039;s release of EUDAMED version 2.22.0, with updates for mandatory medical device registration effective May 2026.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/la-commission-europeenne-publie-la-version-2-22-0-deudamed-qui-integre-des-mises-a-jour-obligatoires-concernant-lenregistrement-des-dispositifs-medicaux-applicables-a-compter-de-mai-2026\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU Commission Releases EUDAMED Version 2.22.0 With Mandatory Medical Device Registration Updates Effective May 2026\" \/>\n<meta property=\"og:description\" content=\"Learn about the EU Commission&#039;s release of EUDAMED version 2.22.0, with updates for mandatory medical device registration effective May 2026.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/la-commission-europeenne-publie-la-version-2-22-0-deudamed-qui-integre-des-mises-a-jour-obligatoires-concernant-lenregistrement-des-dispositifs-medicaux-applicables-a-compter-de-mai-2026\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-16T09:21:56+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-03T04:57:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/eu-commission-releases-eudamed-version-2-22-0-mandatory-medical-device-registration-updates-effective-may-2026.png\" \/>\n\t<meta property=\"og:image:width\" content=\"904\" \/>\n\t<meta property=\"og:image:height\" content=\"622\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Shaffa 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