{"id":1938,"date":"2026-04-12T09:19:31","date_gmt":"2026-04-12T07:19:31","guid":{"rendered":"https:\/\/www.bayoocare.com\/?p=1938"},"modified":"2026-04-17T09:27:10","modified_gmt":"2026-04-17T07:27:10","slug":"quand-un-produit-est-il-un-dispositif-medical-deux-affaires-judiciaires-apportent-un-peu-de-clarte","status":"publish","type":"post","link":"https:\/\/www.bayoocare.com\/fr\/blog\/quand-un-produit-est-il-un-dispositif-medical-deux-affaires-judiciaires-apportent-un-peu-de-clarte\/","title":{"rendered":"Quand un produit est-il un dispositif m\u00e9dical ? Deux affaires judiciaires apportent (un peu) de clart\u00e9"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-right:0px;--awb-padding-left-small:0px;--awb-margin-top:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>Deux proc\u00e8s r\u00e9cents en Allemagne illustrent des questions centrales d&rsquo;interpr\u00e9tation du MDR qui sont cruciales pour de nombreux fabricants. Le tribunal r\u00e9gional de Bochum a soumis \u00e0 la Cour de justice europ\u00e9enne la question de savoir si les bracelets pour patients non imprim\u00e9s, qui doivent contribuer \u00e0 \u00e9viter les erreurs dans le quotidien de l&rsquo;h\u00f4pital, doivent d\u00e9j\u00e0 \u00eatre class\u00e9s comme dispositifs m\u00e9dicaux, bien qu&rsquo;ils n&rsquo;aient aucun effet direct sur ou dans le corps. Il s&rsquo;agit donc de l&rsquo;importance de la finalit\u00e9 et de savoir si une utilit\u00e9 purement organisationnelle est suffisante pour la classification. Une d\u00e9cision de la CJCE est attendue au plus t\u00f4t fin 2025.   <\/p>\n<p>La d\u00e9cision de la Cour d&rsquo;appel de Hanse concernant une application de t\u00e9l\u00e9dermatologie va encore plus loin. Bien que l&rsquo;application ne pose pas elle-m\u00eame de diagnostic, mais se contente de transmettre des donn\u00e9es structur\u00e9es sur la sant\u00e9 \u00e0 des m\u00e9decins sp\u00e9cialistes, elle a \u00e9t\u00e9 class\u00e9e comme dispositif m\u00e9dical de la classe de risque IIa. Le tribunal interpr\u00e8te la r\u00e8gle 11 du MDR de mani\u00e8re large : Il suffit qu&rsquo;un logiciel contribue \u00e0 la base de d\u00e9cisions m\u00e9dicales, une fonction de diagnostic active n&rsquo;est pas n\u00e9cessaire. Il est donc clair que les logiciels n&rsquo;entrent plus automatiquement dans la classe de risque la plus basse.   <\/p>\n<p>Ces deux affaires montrent que les questions li\u00e9es au MDR, telles que la destination et la classification des risques, sont de plus en plus soumises \u00e0 une r\u00e9solution judiciaire, avec des cons\u00e9quences importantes sur les obligations d&rsquo;autorisation, les conditions de concurrence et les opportunit\u00e9s de march\u00e9. Les fabricants qui ont investi t\u00f4t dans la conformit\u00e9 se trouvent de plus en plus dans une situation de d\u00e9s\u00e9quilibre r\u00e9glementaire par rapport \u00e0 leurs concurrents moins conformes. Il est donc urgent d&rsquo;\u00e9tablir des normes uniformes et contraignantes.  <\/p>\n<\/div><div class=\"fusion-text fusion-text-2\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:25px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-padding-top:50px;--awb-padding-right:50px;--awb-padding-bottom:50px;--awb-padding-left:50px;--awb-padding-top-small:35px;--awb-padding-right-small:30px;--awb-padding-bottom-small:35px;--awb-padding-left-small:30px;--awb-overflow:hidden;--awb-bg-color:var(--awb-color1);--awb-bg-color-hover:var(--awb-color1);--awb-bg-size:cover;--awb-box-shadow:0px 2px 7px 0px rgba(0,0,0,0.4);;--awb-border-radius:60px 60px 60px 60px;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:40px;--awb-spacing-right-small:0%;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-center fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"--awb-min-height:no;--awb-min-height-medium:no;--awb-min-height-small:no;--awb-flex-grow:0;--awb-flex-grow-medium:0;--awb-flex-grow-small:0;--awb-flex-shrink:0;--awb-flex-shrink-medium:0;--awb-flex-shrink-small:0;width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_4_5 4_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:80%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.4%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3%;--awb-width-medium:80%;--awb-order-medium:0;--awb-spacing-right-medium:2.4%;--awb-spacing-left-medium:3%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-text-color:var(--awb-color8);--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Contactez-nous<\/h3><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-text-color:var(--awb-color4);\"><p>Vous pr\u00e9voyez de mettre un dispositif m\u00e9dical sur le march\u00e9 et vous recherchez un fabricant l\u00e9gal exp\u00e9riment\u00e9 ? Contactez-nous pour un entretien de conseil sans engagement. Ensemble, nous d\u00e9velopperons la strat\u00e9gie adapt\u00e9e \u00e0 votre dispositif m\u00e9dical.  <\/p>\n<\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button-border-radius-top-left:60px;--button-border-radius-top-right:60px;--button-border-radius-bottom-right:60px;--button-border-radius-bottom-left:60px;\" target=\"_self\" href=\"#contact\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Nous contacter<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-1 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-center fusion-no-small-visibility\" style=\"--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:9.6%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0%;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:9.6%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-1 fb-icon-element fontawesome-icon fa-envelope fas circle-yes\" style=\"--awb-circlecolor:var(--awb-custom_color_3);--awb-circlecolor-hover:var(--awb-custom_color_3);--awb-circlebordercolor-hover:var(--awb-color8);--awb-circlebordersize:0px;--awb-font-size:57.2px;--awb-width:114.4px;--awb-height:114.4px;--awb-line-height:114.4px;--awb-margin-top:0;--awb-margin-right:0;--awb-margin-bottom:0;--awb-margin-left:32.5px;--awb-align-self:flex-end;\"><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Deux proc\u00e9dures allemandes r\u00e9centes mettent en \u00e9vidence des questions centrales d&rsquo;interpr\u00e9tation du MDR : la destination des produits, la classification des risques des logiciels et les cons\u00e9quences pour les fabricants.<\/p>\n","protected":false},"author":40,"featured_media":2267,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[63],"tags":[71,235],"class_list":["post-1938","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-dispositifs-medicaux","tag-procedure-judiciaire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Quand un produit est-il un dispositif m\u00e9dical ? 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