{"id":3075,"date":"2024-05-15T09:08:54","date_gmt":"2024-05-15T07:08:54","guid":{"rendered":"https:\/\/supplaffairs.com\/welcome-to-eudamed\/"},"modified":"2024-09-30T08:39:05","modified_gmt":"2024-09-30T06:39:05","slug":"welcome-to-eudamed","status":"publish","type":"post","link":"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/","title":{"rendered":"Welcome to EUDAMED"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3075\" class=\"elementor elementor-3075 elementor-3054\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-265fe981 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-parent\" data-id=\"265fe981\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1eb8eb6 elementor-widget elementor-widget-text-editor\" data-id=\"1eb8eb6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\n<p><strong>EUDAMED<\/strong> est la base de donn\u00e9es, cr\u00e9\u00e9e par la Commission europ\u00e9enne, qui vise \u00e0 collecter des informations relatives aux dispositifs m\u00e9dicaux commercialis\u00e9s en Europe, conform\u00e9ment aux exigences du MDR 2017\/745 et de l&rsquo;IVDR 2017\/746, afin d&rsquo;am\u00e9liorer la transparence des informations sur ces produits.<\/p>\n\n<p><strong>EUDAMED<\/strong> est structur\u00e9 en six modules interconnect\u00e9s, dont trois sont actuellement op\u00e9rationnels :<\/p>\n\n<ul>\n<li>Enregistrement et gestion des acteurs et des utilisateurs.<\/li>\n\n<li>Base de donn\u00e9es UDI et enregistrement des appareils.<\/li>\n\n<li>Certificats et organismes notifi\u00e9s.<\/li>\n\n<li>Investigation clinique et \u00e9tudes de performance.<\/li>\n\n<li>Vigilance et surveillance post-commercialisation.<\/li>\n\n<li>Surveillance du march\u00e9.<\/li>\n<\/ul>\n\n<p>Le premier <strong>\u201cActor Registration Module\u201d <\/strong> (<a href=\"https:\/\/webgate.ec.europa.eu\/eudamed-help\/en\/actor.html\">Actor (europa.eu)<\/a>) est op\u00e9rationnel depuis d\u00e9cembre 2020.<\/p>\n\n<figure class=\"wp-block-image size-full is-resized\"><img fetchpriority=\"high\" decoding=\"async\" width=\"695\" height=\"813\" class=\"wp-image-3055\" style=\"width: 840px; height: auto;\" src=\"https:\/\/supplaffairs.com\/wp-content\/uploads\/2024\/05\/uuid-93525fad-e153-7a23-b984-ac9847b0f119.png\" alt=\"\" srcset=\"https:\/\/supplaffairs.com\/wp-content\/uploads\/2024\/05\/uuid-93525fad-e153-7a23-b984-ac9847b0f119.png 695w, https:\/\/supplaffairs.com\/wp-content\/uploads\/2024\/05\/uuid-93525fad-e153-7a23-b984-ac9847b0f119-256x300.png 256w\" sizes=\"(max-width: 695px) 100vw, 695px\" \/><\/figure>\n\n<p>Quels sont les op\u00e9rateurs \u00e9conomiques qui doivent s&rsquo;enregistrer aupr\u00e8s d&rsquo;<strong>EUDAMED<\/strong>?<\/p>\n\n<ul>\n<li>Fabricants.<\/li>\n\n<li>Repr\u00e9sentants autoris\u00e9s.<\/li>\n\n<li>Producteurs de packs de syst\u00e8mes et de proc\u00e9dures.<\/li>\n\n<li>Importateurs.<\/li>\n<\/ul>\n\n<p>Les distributeurs ne doivent pas s&rsquo;enregistrer aupr\u00e8s d&rsquo;<strong>EUDAMED.<\/strong><\/p>\n\n<p>Pour plus d\u2019informations, vous avez ce lien de la Commission europ\u00e9enne qui d\u00e9taille les r\u00f4les des diff\u00e9rents agents \u00e9conomiques: <a href=\"https:\/\/webgate.ec.europa.eu\/eudamed-static\/infographics\/md_actor_roles_srn_en_0.pdf\">eudamed (europa.eu) <\/a><\/p>\n\n<p>En outre, les <strong>importateurs sont tenus d\u2019effectuer des<\/strong> <strong>v\u00e9rifications aupr\u00e8s d\u2019EUDAMED:<\/strong><\/p>\n\n<ul>\n<li>V\u00e9rifier que le dispositif m\u00e9dical est enregistr\u00e9 (article 13, paragraphe 4, du MDR).<\/li>\n\n<li>V\u00e9rifier que le fabricant et le repr\u00e9sentant autoris\u00e9 ont communiqu\u00e9 les informations n\u00e9cessaires \u00e0 <strong>EUDAMED<\/strong>, dans les deux semaines suivant la mise sur le march\u00e9 du produit (sauf pour les produits fabriqu\u00e9s sur mesure) et informer ces agents lorsque les informations sont incorrectes ou insuffisantes (article 30(3) du RIM \/ article 27(3) du RIVD \/ article 27(3) du RIVD).<\/li>\n\n<li>V\u00e9rifier que leurs propres informations d\u2019enregistrement sont compl\u00e8tes, exactes et \u00e0 jour avec la p\u00e9riodicit\u00e9 indiqu\u00e9e \u00e0 l\u2019article 31(5) du MDR et \u00e0 l\u2019article 28(5) du IVDR.<\/li>\n<\/ul>\n\n<p>Depuis <span style=\"color: #830934;\"><strong>Supplaffairs<\/strong><\/span> nous pouvons vous aider \u00e0 vous conformer \u00e0 vos obligations d&rsquo;enregistrement <strong>EUDAMED.<\/strong><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>EUDAMED est la base de donn\u00e9es, cr\u00e9\u00e9e par la Commission europ\u00e9enne, qui vise \u00e0 collecter des informations relatives aux dispositifs m\u00e9dicaux commercialis\u00e9s en Europe, conform\u00e9ment aux exigences du MDR 2017\/745 et de l&rsquo;IVDR 2017\/746, afin d&rsquo;am\u00e9liorer la transparence des informations sur ces produits. EUDAMED est structur\u00e9 en six modules interconnect\u00e9s, dont trois sont actuellement op\u00e9rationnels : Enregistrement et gestion des acteurs et des utilisateurs. Base de donn\u00e9es UDI et enregistrement des appareils. Certificats et organismes notifi\u00e9s. Investigation clinique et \u00e9tudes de performance. Vigilance et surveillance post-commercialisation. Surveillance du march\u00e9. Le premier \u201cActor Registration Module\u201d (Actor (europa.eu)) est op\u00e9rationnel depuis d\u00e9cembre 2020. Quels sont les op\u00e9rateurs \u00e9conomiques qui doivent s&rsquo;enregistrer aupr\u00e8s d&rsquo;EUDAMED? Fabricants. Repr\u00e9sentants autoris\u00e9s. Producteurs de packs de syst\u00e8mes et de proc\u00e9dures. Importateurs. Les distributeurs ne doivent pas s&rsquo;enregistrer aupr\u00e8s d&rsquo;EUDAMED. Pour plus d\u2019informations, vous avez ce lien de la Commission europ\u00e9enne qui d\u00e9taille les r\u00f4les des diff\u00e9rents agents \u00e9conomiques: eudamed (europa.eu) En outre, les importateurs sont tenus d\u2019effectuer des v\u00e9rifications aupr\u00e8s d\u2019EUDAMED: V\u00e9rifier que le dispositif m\u00e9dical est enregistr\u00e9 (article 13, paragraphe 4, du MDR). V\u00e9rifier que le fabricant et le repr\u00e9sentant autoris\u00e9 ont communiqu\u00e9 les informations n\u00e9cessaires \u00e0 EUDAMED, dans les deux semaines suivant la mise sur le march\u00e9 du produit (sauf pour les produits fabriqu\u00e9s sur mesure) et informer ces agents lorsque les informations sont incorrectes ou insuffisantes (article 30(3) du RIM \/ article 27(3) du RIVD \/ article 27(3) du RIVD). V\u00e9rifier que leurs propres informations d\u2019enregistrement sont compl\u00e8tes, exactes et \u00e0 jour avec la p\u00e9riodicit\u00e9 indiqu\u00e9e \u00e0 l\u2019article 31(5) du MDR et \u00e0 l\u2019article 28(5) du IVDR. Depuis Supplaffairs nous pouvons vous aider \u00e0 vous conformer \u00e0 vos obligations d&rsquo;enregistrement EUDAMED.<\/p>\n","protected":false},"author":2,"featured_media":3064,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"","ocean_second_sidebar":"","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"","ocean_custom_header_template":"","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"","ocean_menu_typo_font_family":"","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"on","ocean_gallery_id":[],"footnotes":""},"categories":[5],"tags":[],"class_list":["post-3075","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-non-classifiee","entry","has-media"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Welcome to EUDAMED - Supplaffairs<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Welcome to EUDAMED - Supplaffairs\" \/>\n<meta property=\"og:description\" content=\"EUDAMED est la base de donn\u00e9es, cr\u00e9\u00e9e par la Commission europ\u00e9enne, qui vise \u00e0 collecter des informations relatives aux dispositifs m\u00e9dicaux commercialis\u00e9s en Europe, conform\u00e9ment aux exigences du MDR 2017\/745 et de l&rsquo;IVDR 2017\/746, afin d&rsquo;am\u00e9liorer la transparence des informations sur ces produits. EUDAMED est structur\u00e9 en six modules interconnect\u00e9s, dont trois sont actuellement op\u00e9rationnels : Enregistrement et gestion des acteurs et des utilisateurs. Base de donn\u00e9es UDI et enregistrement des appareils. Certificats et organismes notifi\u00e9s. Investigation clinique et \u00e9tudes de performance. Vigilance et surveillance post-commercialisation. Surveillance du march\u00e9. Le premier \u201cActor Registration Module\u201d (Actor (europa.eu)) est op\u00e9rationnel depuis d\u00e9cembre 2020. Quels sont les op\u00e9rateurs \u00e9conomiques qui doivent s&rsquo;enregistrer aupr\u00e8s d&rsquo;EUDAMED? Fabricants. Repr\u00e9sentants autoris\u00e9s. Producteurs de packs de syst\u00e8mes et de proc\u00e9dures. Importateurs. Les distributeurs ne doivent pas s&rsquo;enregistrer aupr\u00e8s d&rsquo;EUDAMED. Pour plus d\u2019informations, vous avez ce lien de la Commission europ\u00e9enne qui d\u00e9taille les r\u00f4les des diff\u00e9rents agents \u00e9conomiques: eudamed (europa.eu) En outre, les importateurs sont tenus d\u2019effectuer des v\u00e9rifications aupr\u00e8s d\u2019EUDAMED: V\u00e9rifier que le dispositif m\u00e9dical est enregistr\u00e9 (article 13, paragraphe 4, du MDR). V\u00e9rifier que le fabricant et le repr\u00e9sentant autoris\u00e9 ont communiqu\u00e9 les informations n\u00e9cessaires \u00e0 EUDAMED, dans les deux semaines suivant la mise sur le march\u00e9 du produit (sauf pour les produits fabriqu\u00e9s sur mesure) et informer ces agents lorsque les informations sont incorrectes ou insuffisantes (article 30(3) du RIM \/ article 27(3) du RIVD \/ article 27(3) du RIVD). V\u00e9rifier que leurs propres informations d\u2019enregistrement sont compl\u00e8tes, exactes et \u00e0 jour avec la p\u00e9riodicit\u00e9 indiqu\u00e9e \u00e0 l\u2019article 31(5) du MDR et \u00e0 l\u2019article 28(5) du IVDR. Depuis Supplaffairs nous pouvons vous aider \u00e0 vous conformer \u00e0 vos obligations d&rsquo;enregistrement EUDAMED.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/\" \/>\n<meta property=\"og:site_name\" content=\"Supplaffairs\" \/>\n<meta property=\"article:published_time\" content=\"2024-05-15T07:08:54+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-30T06:39:05+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/supplaffairs.com\/wp-content\/uploads\/2024\/05\/file.png\" \/>\n\t<meta property=\"og:image:width\" content=\"846\" \/>\n\t<meta property=\"og:image:height\" content=\"484\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"evasuppla\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"evasuppla\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/\"},\"author\":{\"name\":\"evasuppla\",\"@id\":\"https:\/\/supplaffairs.com\/#\/schema\/person\/73e0bb30ac3a51b4a1ebffff55c2c0f7\"},\"headline\":\"Welcome to EUDAMED\",\"datePublished\":\"2024-05-15T07:08:54+00:00\",\"dateModified\":\"2024-09-30T06:39:05+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/\"},\"wordCount\":303,\"publisher\":{\"@id\":\"https:\/\/supplaffairs.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/supplaffairs.com\/wp-content\/uploads\/2024\/05\/file.png\",\"articleSection\":[\"Non classifi\u00e9(e)\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/\",\"url\":\"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/\",\"name\":\"Welcome to EUDAMED - 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EUDAMED est structur\u00e9 en six modules interconnect\u00e9s, dont trois sont actuellement op\u00e9rationnels : Enregistrement et gestion des acteurs et des utilisateurs. Base de donn\u00e9es UDI et enregistrement des appareils. Certificats et organismes notifi\u00e9s. Investigation clinique et \u00e9tudes de performance. Vigilance et surveillance post-commercialisation. Surveillance du march\u00e9. Le premier \u201cActor Registration Module\u201d (Actor (europa.eu)) est op\u00e9rationnel depuis d\u00e9cembre 2020. Quels sont les op\u00e9rateurs \u00e9conomiques qui doivent s&rsquo;enregistrer aupr\u00e8s d&rsquo;EUDAMED? Fabricants. Repr\u00e9sentants autoris\u00e9s. Producteurs de packs de syst\u00e8mes et de proc\u00e9dures. Importateurs. Les distributeurs ne doivent pas s&rsquo;enregistrer aupr\u00e8s d&rsquo;EUDAMED. Pour plus d\u2019informations, vous avez ce lien de la Commission europ\u00e9enne qui d\u00e9taille les r\u00f4les des diff\u00e9rents agents \u00e9conomiques: eudamed (europa.eu) En outre, les importateurs sont tenus d\u2019effectuer des v\u00e9rifications aupr\u00e8s d\u2019EUDAMED: V\u00e9rifier que le dispositif m\u00e9dical est enregistr\u00e9 (article 13, paragraphe 4, du MDR). V\u00e9rifier que le fabricant et le repr\u00e9sentant autoris\u00e9 ont communiqu\u00e9 les informations n\u00e9cessaires \u00e0 EUDAMED, dans les deux semaines suivant la mise sur le march\u00e9 du produit (sauf pour les produits fabriqu\u00e9s sur mesure) et informer ces agents lorsque les informations sont incorrectes ou insuffisantes (article 30(3) du RIM \/ article 27(3) du RIVD \/ article 27(3) du RIVD). V\u00e9rifier que leurs propres informations d\u2019enregistrement sont compl\u00e8tes, exactes et \u00e0 jour avec la p\u00e9riodicit\u00e9 indiqu\u00e9e \u00e0 l\u2019article 31(5) du MDR et \u00e0 l\u2019article 28(5) du IVDR. Depuis Supplaffairs nous pouvons vous aider \u00e0 vous conformer \u00e0 vos obligations d&rsquo;enregistrement EUDAMED.","og_url":"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/","og_site_name":"Supplaffairs","article_published_time":"2024-05-15T07:08:54+00:00","article_modified_time":"2024-09-30T06:39:05+00:00","og_image":[{"width":846,"height":484,"url":"https:\/\/supplaffairs.com\/wp-content\/uploads\/2024\/05\/file.png","type":"image\/png"}],"author":"evasuppla","twitter_card":"summary_large_image","twitter_misc":{"\u00c9crit par":"evasuppla","Dur\u00e9e de lecture estim\u00e9e":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/#article","isPartOf":{"@id":"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/"},"author":{"name":"evasuppla","@id":"https:\/\/supplaffairs.com\/#\/schema\/person\/73e0bb30ac3a51b4a1ebffff55c2c0f7"},"headline":"Welcome to EUDAMED","datePublished":"2024-05-15T07:08:54+00:00","dateModified":"2024-09-30T06:39:05+00:00","mainEntityOfPage":{"@id":"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/"},"wordCount":303,"publisher":{"@id":"https:\/\/supplaffairs.com\/#organization"},"image":{"@id":"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/#primaryimage"},"thumbnailUrl":"https:\/\/supplaffairs.com\/wp-content\/uploads\/2024\/05\/file.png","articleSection":["Non classifi\u00e9(e)"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/","url":"https:\/\/supplaffairs.com\/fr\/welcome-to-eudamed\/","name":"Welcome to EUDAMED - 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