{"id":3073,"date":"2024-05-15T09:08:54","date_gmt":"2024-05-15T07:08:54","guid":{"rendered":"https:\/\/supplaffairs.com\/welcome-to-eudamed\/"},"modified":"2024-09-30T08:36:43","modified_gmt":"2024-09-30T06:36:43","slug":"welcome-to-eudamed","status":"publish","type":"post","link":"https:\/\/supplaffairs.com\/en\/welcome-to-eudamed\/","title":{"rendered":"Welcome to EUDAMED"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3073\" class=\"elementor elementor-3073 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> is the database, created by the European Commission, which aims to collect information related to medical devices marketed in Europe, according to the requirements of MDR 2017\/745 and IVDR 2017\/746, in order to improve transparency in the information on these products.<\/p>\n\n<p><strong>EUDAMED<\/strong> is structured in six interconnected modules, three of which are currently operational:<\/p>\n\n<ul>\n<li>Actor \u2013 user registration and management<\/li>\n\n<li>UDI database and registration of devices<\/li>\n\n<li>Certificates and Notified Bodies<\/li>\n\n<li>Clinical Investigation and performance studies<\/li>\n\n<li>Vigilance and post-market surveillance<\/li>\n\n<li>Market surveillance<\/li>\n<\/ul>\n\n<p>The first Module <strong>\u201cActor Registration Module\u201d <\/strong> (<a href=\"https:\/\/webgate.ec.europa.eu\/eudamed-help\/en\/actor.html\">Actor (europa.eu)<\/a>) has been operational since December 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>Which economic agents must register with <strong>EUDAMED<\/strong>?<\/p>\n\n<ul>\n<li>Manufacturers.<\/li>\n\n<li>Authorized Representatives.<\/li>\n\n<li>System and procedure pack producers.<\/li>\n\n<li>Importers.<\/li>\n<\/ul>\n\n<p>Distributors should not register with <strong>EUDAMED<\/strong>.<\/p>\n\n<p>For more information, you have this link from the European Commission that details the roles of the different economic agents: <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>In addition, <strong>Importers are required to carry out<\/strong> <strong>verifications at EUDAMED:<\/strong><\/p>\n\n<ul>\n<li>Verify that the medical device is registered (Article 13(4) MDR).<\/li>\n\n<li>Verify that the Manufacturer and the Authorized Representative have reported the necessary information in <strong>EUDAMED<\/strong>, within two weeks of the product&#8217;s introduction on the market (except for custom-made products) and inform these agents when the information is incorrect or insufficient (Article 30, paragraph 3 of the MDR\/ Article 27, paragraph 3 of the IVDR).<\/li>\n\n<li>Verify that their own registration information is complete, accurate and up to date with the periodicity indicated in Article 31(5) of the MDR\/ Article 28(5) of the IVDR.<\/li>\n<\/ul>\n\n<p>From <span style=\"color: #830934;\"><strong>Supplaffairs<\/strong><\/span> we can help you to comply with your <strong>EUDAMED<\/strong> registration obligations.<\/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 is the database, created by the European Commission, which aims to collect information related to medical devices marketed in Europe, according to the requirements of MDR 2017\/745 and IVDR 2017\/746, in order to improve transparency in the information on these products. EUDAMED is structured in six interconnected modules, three of which are currently operational: Actor \u2013 user registration and management UDI database and registration of devices Certificates and Notified Bodies Clinical Investigation and performance studies Vigilance and post-market surveillance Market surveillance The first Module \u201cActor Registration Module\u201d (Actor (europa.eu)) has been operational since December 2020. Which economic agents must register with EUDAMED? Manufacturers. Authorized Representatives. System and procedure pack producers. Importers. Distributors should not register with EUDAMED. For more information, you have this link from the European Commission that details the roles of the different economic agents: eudamed (europa.eu) In addition, Importers are required to carry out verifications at EUDAMED: Verify that the medical device is registered (Article 13(4) MDR). Verify that the Manufacturer and the Authorized Representative have reported the necessary information in EUDAMED, within two weeks of the product&#8217;s introduction on the market (except for custom-made products) and inform these agents when the information is incorrect or insufficient (Article 30, paragraph 3 of the MDR\/ Article 27, paragraph 3 of the IVDR). Verify that their own registration information is complete, accurate and up to date with the periodicity indicated in Article 31(5) of the MDR\/ Article 28(5) of the IVDR. From Supplaffairs we can help you to comply with your EUDAMED registration obligations.<\/p>\n","protected":false},"author":2,"featured_media":3063,"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":[1],"tags":[],"class_list":["post-3073","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categorizar","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\/en\/welcome-to-eudamed\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Welcome to EUDAMED - Supplaffairs\" \/>\n<meta property=\"og:description\" content=\"EUDAMED is the database, created by the European Commission, which aims to collect information related to medical devices marketed in Europe, according to the requirements of MDR 2017\/745 and IVDR 2017\/746, in order to improve transparency in the information on these products. 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