{"id":9540,"date":"2026-02-25T10:57:53","date_gmt":"2026-02-25T02:57:53","guid":{"rendered":"https:\/\/regask.com\/?p=9540"},"modified":"2026-02-25T10:57:53","modified_gmt":"2026-02-25T02:57:53","slug":"lautorite-britannique-de-reglementation-des-dispositifs-medicaux-mhra-met-a-jour-ses-directives-denregistrement-notamment-concernant-les-modifications-apportees-en-irlande-du-nord-la-t","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/uk-mhra-updates-medical-device-registration-guidance-with-northern-ireland-changes-eudamed-transition-and-annual-fees\/","title":{"rendered":"L\u2019agence britannique MHRA met \u00e0 jour ses directives d\u2019enregistrement des dispositifs m\u00e9dicaux\u2026"},"content":{"rendered":"<p>Sur <strong>20 f\u00e9vrier 2026, <\/strong>le<strong> Agence de r\u00e9glementation des m\u00e9dicaments et des produits de sant\u00e9<\/strong> L&#039;organisme a publi\u00e9 une mise \u00e0 jour de ses lignes directrices relatives \u00e0 l&#039;enregistrement des dispositifs m\u00e9dicaux en vue de leur mise sur le march\u00e9 en Grande-Bretagne et en Irlande du Nord, conform\u00e9ment \u00e0 la r\u00e9glementation britannique de 2002 sur les dispositifs m\u00e9dicaux. Cette mise \u00e0 jour concerne les fabricants et les mandataires autoris\u00e9s qui mettent sur le march\u00e9 britannique des dispositifs m\u00e9dicaux et des dispositifs de diagnostic in vitro. <strong>March\u00e9s d&#039;Irlande du Nord, avec des implications sur les voies d&#039;immatriculation en Irlande du Nord, les frais d&#039;immatriculation annuels, <\/strong>et<strong> transparence des registres publics. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1140248194\">\n\n\t<div id=\"col-398922996\" 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-930391972\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-930391972 {\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-1343536361\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1343536361 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives mises \u00e0 jour apportent des pr\u00e9cisions sur les points suivants\u00a0: <strong>exigences d&#039;enregistrement en Irlande du Nord <\/strong>devant<strong> 28 mai 2026.<\/strong> \u00c0 compter de cette date, la plupart des dispositifs m\u00e9dicaux non personnalis\u00e9s doivent \u00eatre enregistr\u00e9s dans le <strong>Base de donn\u00e9es europ\u00e9enne sur les dispositifs m\u00e9dicaux<\/strong> avant leur mise sur le march\u00e9 de l&#039;UE ou d&#039;Irlande du Nord, l&#039;enregistrement aupr\u00e8s de la MHRA ne sera plus requis pour ces dispositifs destin\u00e9s au march\u00e9 nord-irlandais. <strong>Appareils sur mesure<\/strong> demeurent hors du champ d&#039;application d&#039;EUDAMED et doivent continuer \u00e0 \u00eatre enregistr\u00e9s aupr\u00e8s de la MHRA pour l&#039;Irlande du Nord.<\/p>\n<p>Le guide introduit un cadre d\u00e9taill\u00e9 pour l&#039;\u00e9valuation annuelle <strong>R\u00e9gime des frais d&#039;inscription de la MHRA <\/strong>entr\u00e9e en vigueur <strong>\u00e0 compter du 1er avril 2026.<\/strong> Les frais seront calcul\u00e9s en fonction de <strong>Nomenclature mondiale des dispositifs m\u00e9dicaux de niveau 2 (GMDN)<\/strong> <strong>cat\u00e9gories<\/strong> enregistr\u00e9 aupr\u00e8s de la MHRA, obligeant les fabricants \u00e0 examiner la structure de leurs portefeuilles de dispositifs \u00e0 des fins d&#039;enregistrement.<\/p>\n<p>Des pr\u00e9cisions suppl\u00e9mentaires sont fournies pour <strong>dispositifs de diagnostic in vitro (DIV)<\/strong> en cours <strong>\u00e9tudes d&#039;\u00e9valuation des performances,<\/strong> confirmant que l&#039;inscription doit \u00eatre effectu\u00e9e avant le d\u00e9but des \u00e9tudes au Royaume-Uni. La mise \u00e0 jour r\u00e9affirme \u00e9galement que <strong>Antig\u00e8ne COVID-19<\/strong> <strong>et dispositifs de test mol\u00e9culaire (PCR)<\/strong> doit obtenir <strong>Approbation du dispositif de test du coronavirus (CTDA)<\/strong> La validation ou l&#039;inscription sur le protocole pertinent sont n\u00e9cessaires avant qu&#039;une demande d&#039;enregistrement aupr\u00e8s de la MHRA ne soit accept\u00e9e.<\/p>\n<p>En outre, les directives confirment des am\u00e9liorations apport\u00e9es \u00e0<strong> Base de donn\u00e9es d&#039;enregistrement d&#039;acc\u00e8s public (PARD).<\/strong> Depuis <strong>23 f\u00e9vrier 2026, marques ou noms commerciaux de dispositifs m\u00e9dicaux<\/strong> seront affich\u00e9es publiquement, ce qui renforcera la transparence autour des produits enregistr\u00e9s.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-398922996 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1005427886\" 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 \u0153uvre r\u00e9glementaire<\/h2>\n\t<div id=\"gap-1955528806\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1955528806 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<ul>\n<li><strong>23 f\u00e9vrier 2026 :<\/strong> Dispositif m\u00e9dical <strong>marques et noms commerciaux<\/strong> commenceront \u00e0 \u00eatre affich\u00e9s sur le <strong>Base de donn\u00e9es d&#039;enregistrement d&#039;acc\u00e8s public (PARD),<\/strong> Accro\u00eetre la visibilit\u00e9 publique des produits enregistr\u00e9s.<\/li>\n<li><strong>1er avril 2026 : Frais d&#039;inscription annuels <\/strong>pour les dispositifs m\u00e9dicaux enregistr\u00e9s aupr\u00e8s de la<strong> Agence de r\u00e9glementation des m\u00e9dicaments et des produits de sant\u00e9<\/strong> entrera en vigueur, les frais \u00e9tant calcul\u00e9s par <strong>Cat\u00e9gorie de niveau 2 de la nomenclature mondiale des dispositifs m\u00e9dicaux (GMDN).\u00a0<\/strong><\/li>\n<li><strong>28 mai 2026 : Enregistrement EUDAMED<\/strong> deviendra obligatoire pour la plupart <strong>dispositifs m\u00e9dicaux non personnalis\u00e9s<\/strong> mis sur les march\u00e9s de l&#039;UE ou d&#039;Irlande du Nord. \u00c0 compter de cette date, <strong>L&#039;inscription aupr\u00e8s de la MHRA ne sera plus requise.<\/strong> pour ces appareils destin\u00e9s au march\u00e9 d&#039;Irlande du Nord.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1005427886 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1673632357\" 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-1727267171\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1727267171 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour offre une plus grande autonomie <strong>clart\u00e9 r\u00e9glementaire<\/strong> concernant les dispositions post-transition pour l&#039;Irlande du Nord, aligne les processus britanniques sur <strong>Infrastructure num\u00e9rique de l&#039;UE<\/strong> par le biais d&#039;EUDAMED, et \u00e9tablit une structure <strong>cadre de tarification<\/strong> Ces changements visent \u00e0 faciliter le contr\u00f4le r\u00e9glementaire et \u00e0 am\u00e9liorer l&#039;efficacit\u00e9 et la transparence, tout en concentrant la charge administrative suppl\u00e9mentaire sur les activit\u00e9s d&#039;enregistrement et de gestion des donn\u00e9es.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1673632357 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-190448448\" 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-1627123610\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1627123610 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ces recommandations concernent <strong>Fabricants de dispositifs m\u00e9dicaux et de DIV, repr\u00e9sentants autoris\u00e9s, <\/strong>et<strong> \u00e9quipes r\u00e9glementaires, de qualit\u00e9 et de conformit\u00e9<\/strong> responsable de l&#039;acc\u00e8s au march\u00e9 du Royaume-Uni et de l&#039;Irlande du Nord, ainsi que de <strong>\u00e9quipes informatiques et de donn\u00e9es<\/strong> Gestion des soumissions r\u00e9glementaires et des informations publiques sur les produits.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-190448448 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-683612304\" 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-1206144597\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1206144597 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les parties prenantes devraient examiner leurs enregistrements actuels aupr\u00e8s de la MHRA afin d&#039;identifier les dispositifs qui n\u00e9cessiteront une autorisation. <strong>Enregistrement EUDAMED<\/strong> d\u2019ici fin mai 2026, \u00e9valuer l\u2019impact de <strong>frais annuels<\/strong> Avant avril 2026, et mettre \u00e0 jour les processus internes en cons\u00e9quence. Les fabricants commercialisant leurs appareils en Irlande du Nord doivent \u00e9galement le confirmer. <strong>dispositions relatives aux repr\u00e9sentants autoris\u00e9s,<\/strong> assurer <strong>Validation CTDA<\/strong> le cas \u00e9ch\u00e9ant, et pr\u00e9parez-vous \u00e0 une visibilit\u00e9 accrue des d\u00e9tails des produits sur PARD.<\/p>\n<p>\u00c0 mesure que les organisations s&#039;adaptent \u00e0 l&#039;\u00e9volution des exigences d&#039;enregistrement au Royaume-Uni et en Irlande du Nord, <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> Elle apporte son soutien aux \u00e9quipes de r\u00e9glementation et de conformit\u00e9 en surveillant les d\u00e9lais de mise en \u0153uvre, en assurant le suivi des obligations sp\u00e9cifiques \u00e0 chaque juridiction et en rationalisant les flux de travail d&#039;enregistrement et de gestion des donn\u00e9es. <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/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, qui permet aux organisations mondiales des secteurs hautement r\u00e9glement\u00e9s, notamment les produits de consommation et les sciences de la vie, de naviguer de mani\u00e8re proactive dans des environnements r\u00e9glementaires complexes. <strong>En combinant une IA agentique avanc\u00e9e avec des experts impliqu\u00e9s, <a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a><\/strong> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <a href=\"http:\/\/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-683612304 > .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-830219199\">\n\n\t<div id=\"col-64398957\" 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-1468502144\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1468502144 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Quels changements la MHRA a-t-elle introduits concernant l&#039;enregistrement des dispositifs m\u00e9dicaux en Irlande du Nord\u00a0?<\/h4>\n\t<div id=\"gap-554353066\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-554353066 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u00c0 compter du 28 mai 2026, la plupart des dispositifs non personnalis\u00e9s devront \u00eatre enregistr\u00e9s dans EUDAMED pour les march\u00e9s de l&#039;UE et d&#039;Irlande du Nord, et l&#039;enregistrement aupr\u00e8s de la MHRA ne sera plus requis pour ces dispositifs en Irlande du Nord.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-64398957 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-983135376\" 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>\u00c0 quelle date entrent en vigueur les frais annuels d&#039;enregistrement des dispositifs m\u00e9dicaux aupr\u00e8s de la MHRA\u00a0?<\/h4>\n\t<div id=\"gap-196359195\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-196359195 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les frais d&#039;inscription annuels entreront en vigueur le 1er avril 2026 et seront calcul\u00e9s par cat\u00e9gorie GMDN de niveau 2 enregistr\u00e9e aupr\u00e8s de la MHRA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-983135376 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1396856424\" 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>Les dispositifs m\u00e9dicaux sur mesure doivent-ils \u00eatre enregistr\u00e9s aupr\u00e8s d&#039;EUDAMED\u00a0?<\/h4>\n\t<div id=\"gap-1869065537\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1869065537 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Non. Les dispositifs sur mesure ne n\u00e9cessitent pas d&#039;enregistrement EUDAMED et doivent continuer \u00e0 \u00eatre enregistr\u00e9s aupr\u00e8s de la MHRA pour le march\u00e9 nord-irlandais.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1396856424 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-941490033\" 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 \u00e9quipes \u00e0 g\u00e9rer ces changements d&#039;enregistrement aupr\u00e8s de la MHRA\u00a0?<\/h4>\n\t<div id=\"gap-1626816534\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1626816534 {\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 \u00e9quipes charg\u00e9es des affaires r\u00e9glementaires et de la conformit\u00e9 \u00e0 suivre les \u00e9ch\u00e9ances \u00e0 venir, \u00e0 \u00e9valuer l&#039;impact des nouvelles structures tarifaires et \u00e0 g\u00e9rer les obligations d&#039;enregistrement au Royaume-Uni, en Irlande du Nord et dans l&#039;UE gr\u00e2ce \u00e0 des renseignements r\u00e9glementaires centralis\u00e9s et des flux de travail automatis\u00e9s.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-941490033 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Le 20 f\u00e9vrier 2026, la Medicines &amp; Healthcare products Regulatory Agency (MHRA) a publi\u00e9 une mise \u00e0 jour de ses lignes directrices relatives \u00e0 l&#039;enregistrement des dispositifs m\u00e9dicaux en vue de leur mise sur le march\u00e9 en Grande-Bretagne et en Irlande du Nord, conform\u00e9ment \u00e0 la r\u00e9glementation britannique de 2002 sur les dispositifs m\u00e9dicaux. Cette mise \u00e0 jour concerne les fabricants et les mandataires autoris\u00e9s qui mettent sur le march\u00e9 des dispositifs m\u00e9dicaux et des dispositifs de diagnostic in vitro\u2026<\/p>","protected":false},"author":43,"featured_media":9543,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,39],"tags":[],"class_list":["post-9540","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.7 (Yoast SEO v28.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Updates Medical Device Registration Guidance<\/title>\n<meta name=\"description\" content=\"Explore UK MHRA updates on medical device registration guidance and how Northern Ireland changes affect manufacturers.\" \/>\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\/lautorite-britannique-de-reglementation-des-dispositifs-medicaux-mhra-met-a-jour-ses-directives-denregistrement-notamment-concernant-les-modifications-apportees-en-irlande-du-nord-la-t\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK MHRA Updates Medical Device Registration Guidance with Northern Ireland Changes, EUDAMED Transition, and Annual Fees\" \/>\n<meta property=\"og:description\" content=\"Explore UK MHRA updates on medical device registration guidance and how Northern Ireland changes affect manufacturers.\" \/>\n<meta property=\"og:url\" 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