L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a publi\u00e9 le 7 ao\u00fbt 2026 une injonction (n\u00b0 2026-DM-DIV-014-INJ) \u00e0 l\u2019encontre de l\u2019\u00e9tablissement de la soci\u00e9t\u00e9 JCD SA, situ\u00e9 \u00e0 La Mulati\u00e8re (Rh\u00f4ne), en application des articles L. 5311-1, L. 5312-4-3 et L. 5313-1 du code de la sant\u00e9 publique. Cette d\u00e9cision fait suite \u00e0 une inspection r\u00e9alis\u00e9e du 2 au 5 mars 2026, au cours de laquelle des non-conformit\u00e9s et manquements importants ont \u00e9t\u00e9 constat\u00e9s, puis notifi\u00e9s \u00e0 l\u2019\u00e9tablissement par une lettre pr\u00e9alable \u00e0 injonction dat\u00e9e du 29 avril 2026.<\/p>\n
Malgr\u00e9 les r\u00e9ponses apport\u00e9es par JCD SA les 13 mai et 16 juin 2026, l\u2019ANSM consid\u00e8re que plusieurs non-conformit\u00e9s n\u2019ont pas \u00e9t\u00e9 corrig\u00e9es de mani\u00e8re satisfaisante. Il s\u2019agit notamment d\u2019une insuffisance des moyens mis en \u0153uvre par l\u2019entreprise, en tant que distributeur de dispositifs m\u00e9dicaux et de dispositifs m\u00e9dicaux de diagnostic in vitro, pour disposer de l\u2019ensemble des d\u00e9clarations CE\/UE et, le cas \u00e9ch\u00e9ant, des certificats de conformit\u00e9 CE\/UE valides avant la mise \u00e0 disposition des produits, en r\u00e9f\u00e9rence aux articles 14.2 et 14.4 des r\u00e8glements (UE) 2017\/745 et 2017\/746. L\u2019ANSM rel\u00e8ve \u00e9galement une insuffisance des moyens pour v\u00e9rifier et enregistrer syst\u00e9matiquement les preuves de conformit\u00e9 \u00e0 l\u2019ensemble des exigences r\u00e9glementaires relatives \u00e0 l\u2019\u00e9tiquetage et aux notices d\u2019utilisation des dispositifs import\u00e9s et\/ou distribu\u00e9s, en lien avec les articles R.5211-20 et R.5221 du code de la sant\u00e9 publique.<\/p>\n
Cette injonction illustre le contr\u00f4le exerc\u00e9 par l\u2019ANSM sur les acteurs de la distribution de dispositifs m\u00e9dicaux et de dispositifs m\u00e9dicaux de diagnostic in vitro, ainsi que la mise en \u0153uvre des exigences europ\u00e9ennes et nationales en mati\u00e8re de conformit\u00e9, d\u2019\u00e9tiquetage et d\u2019information des utilisateurs. Elle s\u2019inscrit dans un cadre de surveillance visant la s\u00e9curit\u00e9 sanitaire et la qualit\u00e9 des produits de sant\u00e9 mis sur le march\u00e9 fran\u00e7ais.\u00a0(contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a publi\u00e9 le 7 ao\u00fbt 2026 une injonction (n\u00b0 2026-DM-DIV-014-INJ) \u00e0 l\u2019encontre de l\u2019\u00e9tablissement de la soci\u00e9t\u00e9 JCD […]<\/p>\n","protected":false},"author":1,"featured_media":3852,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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