{"id":16606,"date":"2026-09-02T17:41:11","date_gmt":"2026-09-02T17:41:11","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=16606"},"modified":"2026-09-02T17:41:11","modified_gmt":"2026-09-02T17:41:11","slug":"injonction-n-2026-dm-046-inj-portant-sur-letablissement-de-la-societe-surgifrance-situe-a-valbonne-alpes-maritimes-535-route-de-lucioles","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=16606","title":{"rendered":"Injonction n\u00b0 2026-DM-046-INJ portant sur l\u2019\u00e9tablissement de la soci\u00e9t\u00e9 Surgifrance situ\u00e9 \u00e0 Valbonne (Alpes-Maritimes), 535 route de Lucioles"},"content":{"rendered":"

L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a pris une injonction, r\u00e9f\u00e9renc\u00e9e n\u00b0 2026-DM-046-INJ, \u00e0 l\u2019encontre de l\u2019\u00e9tablissement de la soci\u00e9t\u00e9 Surgifrance, situ\u00e9 \u00e0 Valbonne (Alpes-Maritimes), 535 route des Lucioles. Cette mesure, publi\u00e9e le 2 septembre 2026, est prise en application des articles L. 5311-1, L. 5312-4-3 et L. 5313-1 du code de la sant\u00e9 publique, \u00e0 la suite d\u2019une inspection r\u00e9alis\u00e9e sur site du 27 au 28 mai 2026.<\/p>\n

L\u2019inspection a mis en \u00e9vidence des non-conformit\u00e9s et manquements importants dans les activit\u00e9s de Surgifrance en tant qu\u2019importateur et\/ou distributeur de dispositifs m\u00e9dicaux, au regard du R\u00e8glement (UE) 2017\/745. Malgr\u00e9 une lettre pr\u00e9alable \u00e0 injonction adress\u00e9e le 9 juillet 2026 et les r\u00e9ponses apport\u00e9es par l\u2019\u00e9tablissement les 24 juillet et 4 ao\u00fbt 2026, plusieurs points n\u2019ont pas \u00e9t\u00e9 r\u00e9solus de mani\u00e8re jug\u00e9e satisfaisante par l\u2019ANSM.<\/p>\n

Les manquements relev\u00e9s concernent principalement l\u2019absence de l\u2019ensemble des documents r\u00e9glementaires requis avant la mise sur le march\u00e9 ou la mise \u00e0 disposition sur le march\u00e9 des dispositifs m\u00e9dicaux (articles 13, paragraphes 2a, et 14, paragraphe 2a du R\u00e8glement (UE) 2017\/745). Ils portent \u00e9galement sur l\u2019absence de modalit\u00e9s de v\u00e9rification et de contr\u00f4le exerc\u00e9es par Surgifrance en tant qu\u2019importateur et\/ou distributeur (articles 13, paragraphes 1 et 2, et 14, paragraphes 1 et 2). Enfin, l\u2019ANSM constate l\u2019absence d\u2019enregistrement de l\u2019ensemble des r\u00e9clamations et non-conformit\u00e9s, ainsi que l\u2019absence de mise en place d\u2019un registre d\u00e9di\u00e9, en contradiction avec les exigences des articles 13, paragraphes 6, 7 et 8, et 14, paragraphes 4 et 5 du m\u00eame r\u00e8glement.<\/p>\n

Cette injonction illustre un contr\u00f4le de la conformit\u00e9 des op\u00e9rateurs fran\u00e7ais de dispositifs m\u00e9dicaux au cadre r\u00e9glementaire europ\u00e9en, en particulier concernant la tra\u00e7abilit\u00e9 documentaire, les proc\u00e9dures de contr\u00f4le interne et la gestion des r\u00e9clamations et non-conformit\u00e9s, avec des enjeux directs pour la s\u00e9curit\u00e9 des produits de sant\u00e9 mis sur le march\u00e9.\u00a0(contenu r\u00e9sum\u00e9 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 pris une injonction, r\u00e9f\u00e9renc\u00e9e n\u00b0 2026-DM-046-INJ, \u00e0 l\u2019encontre de l\u2019\u00e9tablissement de la soci\u00e9t\u00e9 Surgifrance, situ\u00e9 \u00e0 Valbonne […]<\/p>\n","protected":false},"author":1,"featured_media":3852,"comment_status":"","ping_status":"","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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[63,227],"class_list":["post-16606","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ansm","tag-ia"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/16606","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=16606"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/16606\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/3852"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16606"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16606"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}