{"id":33921,"date":"2026-04-10T09:24:17","date_gmt":"2026-04-10T12:24:17","guid":{"rendered":"https:\/\/sobelconsult.com\/mdr-ivdr-revision-unique-device-identification-codes\/"},"modified":"2026-04-10T09:24:53","modified_gmt":"2026-04-10T12:24:53","slug":"mdr-ivdr-revision-unique-device-identification-codes","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/fr\/mdr-ivdr-revision-unique-device-identification-codes\/","title":{"rendered":"Nouvelles : R\u00e9vision du MDR\/IVDR et codes uniques d&rsquo;identification des dispositifs en Chine"},"content":{"rendered":"\n<p>Les autorit\u00e9s r\u00e9glementaires du monde entier <strong>cherchent \u00e0 am\u00e9liorer la pr\u00e9visibilit\u00e9, la transparence et l&rsquo;harmonisation<\/strong>. En cons\u00e9quence, les changements r\u00e9glementaires en Europe - tels que la r\u00e9vision du MDR\/IVDR - et la mise en \u0153uvre des codes d&rsquo;identification uniques des dispositifs (UDI) en Chine ont lieu simultan\u00e9ment. <\/p>\n\n<p>Pour les professionnels du secteur des dispositifs m\u00e9dicaux, rester \u00e0 jour fait toute la diff\u00e9rence. Cet article a \u00e9t\u00e9 cr\u00e9\u00e9 dans ce but : vous tenir inform\u00e9 des d\u00e9veloppements r\u00e9glementaires les plus pertinents de ces derni\u00e8res semaines. <\/p>\n\n<p><strong>Conseil : <\/strong>les personnes qui s&rsquo;inscrivent \u00e0 notre lettre d&rsquo;information ont re\u00e7u tout ce contenu \u00e0 l&rsquo;avance. Ne manquez pas de vous abonner<strong>gratuitement pour recevoir la lettre d&rsquo;information de <\/strong> Sobel<strong>. <\/strong><a href=\"https:\/\/sobelconsult.com\/?popup=810\"><strong>Sobel News Round Up<\/strong><\/a><strong>.<\/strong> <\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-european-union-signals-progress-on-mdr-and-ivdr-revisions\">L&rsquo;Union europ\u00e9enne signale des progr\u00e8s dans la r\u00e9vision des MDR et des IVDR<\/h2>\n\n<p>Les <strong>autorit\u00e9s de l&rsquo;Union europ\u00e9enne se sont montr\u00e9es optimistes<\/strong> quant aux <a href=\"https:\/\/www.raps.org\/resource\/eu-officials-optimistic-about-proposed-mdr-ivdr-re.html\">propositions de r\u00e9vision du r\u00e8glement relatif aux dispositifs m\u00e9dicaux (MDR) et du r\u00e8glement relatif au diagnostic in vitro (IVDR).<\/a><\/p>\n\n<p>Les discussions se concentrent sur les d\u00e9fis bien connus de la mise en \u0153uvre depuis l&rsquo;entr\u00e9e en vigueur des r\u00e8glements. Les principaux probl\u00e8mes sont la capacit\u00e9 limit\u00e9e des organismes notifi\u00e9s, les d\u00e9lais de transition difficiles \u00e0 respecter et la charge administrative importante impos\u00e9e aux fabricants. <\/p>\n\n<p>Bien que les propositions soient encore en cours d&rsquo;\u00e9valuation, <strong>le signal positif sugg\u00e8re une ouverture \u00e0 des ajustements bas\u00e9s sur l&rsquo;exp\u00e9rience r\u00e9elle de l&rsquo;industrie,<\/strong> sans compromettre les exigences en mati\u00e8re de s\u00e9curit\u00e9 et de performance des dispositifs.<\/p>\n\n<p>Vous fabriquez des dispositifs m\u00e9dicaux et envisagez d&rsquo;<a href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-europe\/\">acc\u00e9der au march\u00e9 europ\u00e9en<\/a>? Dans ce cas, restez vigilant et r\u00e9\u00e9valuez vos strat\u00e9gies r\u00e9glementaires. <\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-china-sets-final-deadline-for-full-udi-compliance\">La Chine fixe la date limite pour la mise en conformit\u00e9 totale avec l&rsquo;UDI<\/h2>\n\n<p>Avez-vous entendu parler de l&rsquo;acronyme UDI ? Il <strong>d\u00e9signe les codes d&rsquo;identification uniques des dispositifs<\/strong>, un syst\u00e8me con\u00e7u pour permettre le contr\u00f4le et la tra\u00e7abilit\u00e9 des produits m\u00e9dicaux.<\/p>\n\n<p><strong>Les exigences de l&rsquo;UDI sont d\u00e9j\u00e0 mises en \u0153uvre dans plusieurs pays.<\/strong> En Chine, les autorit\u00e9s ont annonc\u00e9 que tous les dispositifs m\u00e9dicaux devront \u00eatre <a href=\"https:\/\/cisema.com\/en\/china-mandates-full-udi-compliance-for-all-medical-devices-by-2029\/\">enti\u00e8rement conformes aux exigences de l&rsquo;UDI d&rsquo;ici \u00e0 2029<\/a>.<\/p>\n\n<p>Cette mesure renforce la tra\u00e7abilit\u00e9 tout au long du cycle de vie des produits, am\u00e9liore la surveillance apr\u00e8s la mise sur le march\u00e9 et aligne davantage la Chine sur les pratiques r\u00e9glementaires internationales.<\/p>\n\n<p>En outre, cette exigence renforce la pertinence des codes d&rsquo;identification uniques des dispositifs <strong>en tant qu&rsquo;\u00e9l\u00e9ment central du contr\u00f4le r\u00e9glementaire, de la logistique, des rappels et du suivi de la s\u00e9curit\u00e9.<\/strong><\/p>\n\n<p>Les entreprises qui op\u00e8rent sur le march\u00e9 chinois ou qui pr\u00e9voient d&rsquo;y entrer doivent int\u00e9grer cette exigence dans leurs strat\u00e9gies r\u00e9glementaires le plus t\u00f4t possible.<\/p>\n\n<p><strong>Conseil : si votre entreprise envisage d&rsquo;\u00e9tendre ses activit\u00e9s et de commercialiser ses produits en Chine, l&rsquo;un des plus grands march\u00e9s du monde, faites confiance \u00e0 Sobel !<\/strong><\/p>\n\n<p>Nous disposons de sp\u00e9cialistes enti\u00e8rement d\u00e9di\u00e9s aux op\u00e9rations r\u00e9glementaires en Chine, aidant les fabricants \u00e0 naviguer dans ces processus avec plus d&rsquo;efficacit\u00e9 et de confiance.<\/p>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-vivid-cyan-blue-background-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/sobelconsult.com\/#footer-cta\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Parler \u00e0 Sobel<\/strong><\/a><\/div>\n<\/div>\n\n<p><strong>H2 : L&rsquo;Anvisa lance un groupe de suivi pour l&rsquo;agenda r\u00e9glementaire 2026-2027<\/strong><\/p>\n\n<p>Au Br\u00e9sil, l&rsquo;Anvisa a lanc\u00e9 un <strong>tableau de bord public pour suivre ses activit\u00e9s. <\/strong><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/anvisa-publica-painel-de-acompanhamento-da-agenda-regulatoria-2026-2027\"><strong>Programme r\u00e9glementaire 2026-2027<\/strong><\/a><strong>.<\/strong><\/p>\n\n<p><strong>Cet outil offre une meilleure visibilit\u00e9 des actions planifi\u00e9es, des calendriers et des priorit\u00e9s r\u00e9glementaires.<\/strong>  Dans la pratique, elle renforce la transparence et permet aux entreprises de planifier de mani\u00e8re plus strat\u00e9gique.<\/p>\n\n<p>Un autre d\u00e9veloppement important est la <strong>signature par Anvisa de la D\u00e9claration de Rio de Janeiro<\/strong>, avec plusieurs autorit\u00e9s de r\u00e9gulation latino-am\u00e9ricaines.<\/p>\n\n<p><strong>Cette \u00e9tape repr\u00e9sente un engagement en faveur de la convergence r\u00e9glementaire.<\/strong>  Cette initiative vise \u00e0 renforcer la coop\u00e9ration entre les agences, \u00e0 rationaliser les processus et \u00e0 faciliter l&rsquo;acc\u00e8s au march\u00e9 dans toute la r\u00e9gion.<\/p>\n\n<p>En outre, il devrait favoriser l&rsquo;alignement des exigences techniques et administratives, y compris celles li\u00e9es aux codes d&rsquo;identification uniques des dispositifs.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-a-new-tool-on-the-sobel-website\">Un nouvel outil sur le site Sobel<\/h2>\n\n<p>Vous souhaitez r\u00e9gulariser un dispositif m\u00e9dical, un produit cosm\u00e9tique ou un DIV, mais <strong>vous ne savez pas de quel service vous avez besoin ?<\/strong><\/p>\n\n<p>Sobel a la solution ! <strong>Nous avons lanc\u00e9 un nouvel outil sur notre site web<\/strong>, con\u00e7u pour vous guider dans votre parcours r\u00e9glementaire.<\/p>\n\n<p>Voici comment cela fonctionne : en cliquant sur le bouton \u00ab\u00a0chat\u00a0\u00bb au bas du site web (ou en acc\u00e9dant <a href=\"https:\/\/sobelconsult.com\/fr\/find-your-regulatory-path\/\">directement \u00e0 l&rsquo;outil<\/a>), vous r\u00e9pondrez \u00e0 quelques questions.<\/p>\n\n<p>A la fin, l <strong>&lsquo;\u00e9cran affiche les services recommand\u00e9s pour votre cas<\/strong>, ainsi que la possibilit\u00e9 d&rsquo;\u00eatre contact\u00e9 par notre \u00e9quipe de sp\u00e9cialistes.<\/p>\n\n<p>Il s&rsquo;agit d&rsquo;une ressource pratique et hautement fonctionnelle qui vous aidera \u00e0 identifier la meilleure voie pour votre processus r\u00e9glementaire.<\/p>\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/sobelconsult.com\/fr\/find-your-regulatory-path\/\" target=\"_blank\" rel=\" noreferrer noopener\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"419\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/Regulatory-Journey-Tool-1024x419.png\" alt=\"\" class=\"wp-image-33907\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/Regulatory-Journey-Tool-1024x419.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/Regulatory-Journey-Tool-300x123.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/Regulatory-Journey-Tool-768x314.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/Regulatory-Journey-Tool-1536x629.png 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/Regulatory-Journey-Tool.png 1884w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n<h2 class=\"wp-block-heading\" id=\"h-what-do-these-changes-mean-for-your-business\">Que signifient ces changements pour votre entreprise ?<\/h2>\n\n<p>Comme vous l&rsquo;avez constat\u00e9, de nombreux pays prennent des mesures importantes dans leur cadre r\u00e9glementaire.<\/p>\n\n<p>Dans l&rsquo;ensemble, ces initiatives t\u00e9moignent d&rsquo;un effort global en faveur de syst\u00e8mes r\u00e9glementaires plus pr\u00e9visibles, int\u00e9gr\u00e9s et ax\u00e9s sur la s\u00e9curit\u00e9 des patients.<\/p>\n\n<p>C&rsquo;est pourquoi il est essentiel de rester inform\u00e9. Cela permet de prendre des d\u00e9cisions strat\u00e9giques plus s\u00fbres, que ce soit pour les soumissions r\u00e9glementaires ou pour la mise en \u0153uvre de codes d&rsquo;identification uniques sur diff\u00e9rents march\u00e9s. <\/p>\n\n<p>L&rsquo;anticipation des tendances r\u00e9glementaires permet aux entreprises d&rsquo;ajuster leurs feuilles de route, d&rsquo;optimiser leurs ressources et de renforcer leur comp\u00e9titivit\u00e9 dans un environnement de plus en plus r\u00e9glement\u00e9 et interconnect\u00e9.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Outre l&rsquo;examen du MDR\/IVDR, un dernier d\u00e9lai a \u00e9t\u00e9 accord\u00e9 aux codes d&rsquo;identification uniques des dispositifs en Chine. Pour en savoir plus. <\/p>\n","protected":false},"author":16,"featured_media":33903,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[314],"tags":[315,256,299,331,136,159,430],"class_list":["post-33921","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites","tag-actualites","tag-anvisa-fr","tag-brazil-fr","tag-china-fr","tag-dispositifs-medicaux","tag-fda-fr","tag-udi"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Nouvelles : R\u00e9vision du MDR\/IVDR et codes uniques d&#039;identification des dispositifs en Chine - Sobel<\/title>\n<meta name=\"description\" content=\"Outre l&#039;examen du MDR\/IVDR, un dernier d\u00e9lai a \u00e9t\u00e9 accord\u00e9 aux codes d&#039;identification uniques des dispositifs en Chine. 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