{"id":3078,"date":"2024-05-15T09:08:54","date_gmt":"2024-05-15T07:08:54","guid":{"rendered":"https:\/\/supplaffairs.com\/welcome-to-eudamed\/"},"modified":"2024-09-30T08:46:41","modified_gmt":"2024-09-30T06:46:41","slug":"welcome-to-eudamed","status":"publish","type":"post","link":"https:\/\/supplaffairs.com\/pt-pt\/welcome-to-eudamed\/","title":{"rendered":"Welcome to EUDAMED"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3078\" class=\"elementor elementor-3078 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> \u00e9 a base de dados, criada pela Comiss\u00e3o Europeia, que visa recolher informa\u00e7\u00f5es relacionadas com os dispositivos m\u00e9dicos comercializados na Europa, de acordo com os requisitos do MDR 2017\/745 e do IVDR 2017\/746, a fim de melhorar a transpar\u00eancia das informa\u00e7\u00f5es sobre estes produtos.<\/p>\n\n<p>A <strong>EUDAMED<\/strong> est\u00e1 estruturada em seis m\u00f3dulos interligados, tr\u00eas dos quais est\u00e3o atualmente operacionais:<\/p>\n\n<ul>\n<li>Ator \u2013 registo e gest\u00e3o de utilizadores<\/li>\n\n<li>Base de dados UDI e registo de dispositivos<\/li>\n\n<li>Certificados e Organismos Notificados<\/li>\n\n<li>Investiga\u00e7\u00e3o cl\u00ednica e estudos de desempenho<\/li>\n\n<li>Vigil\u00e2ncia e vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o<\/li>\n\n<li>Vigil\u00e2ncia do mercado<\/li>\n<\/ul>\n\n<p>O primeiro <strong>\u201cActor Registration Module\u201d <\/strong> (<a href=\"https:\/\/webgate.ec.europa.eu\/eudamed-help\/en\/actor.html\">Actor (europa.eu)<\/a>) est\u00e1 operacional desde dezembro de 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>Que operadores econ\u00f3micos t\u00eam de se registar na <strong>EUDAMED<\/strong>?<\/p>\n\n<ul>\n<li>Fabricantes.<\/li>\n\n<li>Representantes autorizados.<\/li>\n\n<li>Produtores de pacotes de sistemas e procedimentos.<\/li>\n\n<li>Importadores.<\/li>\n<\/ul>\n\n<p>Os distribuidores n\u00e3o devem registar-se na <strong>EUDAMED<\/strong>.<\/p>\n\n<p>Para mais informa\u00e7\u00f5es, tem esta liga\u00e7\u00e3o da Comiss\u00e3o Europeia que detalha os pap\u00e9is dos diferentes agentes econ\u00f3micos: <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>Al\u00e9m disso, <strong>os importadores s\u00e3o obrigados a realizar<\/strong> <strong>verifica\u00e7\u00f5es no EUDAMED:<\/strong><\/p>\n\n<ul>\n<li>Verificar se o dispositivo m\u00e9dico est\u00e1 registado (artigo 13(4) do MDR).<\/li>\n\n<li>Verifica se o Fabricante e o Representante Autorizado comunicaram as informa\u00e7\u00f5es necess\u00e1rias \u00e0 <strong>EUDAMED<\/strong>, no prazo de duas semanas ap\u00f3s a coloca\u00e7\u00e3o do produto no mercado (exceto no caso de produtos feitos por medida) e informa estes agentes quando as informa\u00e7\u00f5es s\u00e3o incorrectas ou insuficientes (RDM, artigo 30.\u00ba, n.\u00ba 3 \/ RIV, artigo 27.\u00ba, n.\u00ba 3 \/ RIV, n.\u00ba 3).<\/li>\n\n<li>Verificar se as suas pr\u00f3prias informa\u00e7\u00f5es cadastrais est\u00e3o completas, precisas e atualizadas com a periodicidade indicada no artigo 31(5) do MDR\/ artigo 28(5) do IVDR.<\/li>\n<\/ul>\n\n<p><span style=\"color: #830934;\"><strong>Supplaffairs<\/strong><\/span> pode ajudar-te a cumprir as tuas obriga\u00e7\u00f5es de registo <strong>na 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 \u00e9 a base de dados, criada pela Comiss\u00e3o Europeia, que visa recolher informa\u00e7\u00f5es relacionadas com os dispositivos m\u00e9dicos comercializados na Europa, de acordo com os requisitos do MDR 2017\/745 e do IVDR 2017\/746, a fim de melhorar a transpar\u00eancia das informa\u00e7\u00f5es sobre estes produtos. A EUDAMED est\u00e1 estruturada em seis m\u00f3dulos interligados, tr\u00eas dos quais est\u00e3o atualmente operacionais: Ator \u2013 registo e gest\u00e3o de utilizadores Base de dados UDI e registo de dispositivos Certificados e Organismos Notificados Investiga\u00e7\u00e3o cl\u00ednica e estudos de desempenho Vigil\u00e2ncia e vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o Vigil\u00e2ncia do mercado O primeiro \u201cActor Registration Module\u201d (Actor (europa.eu)) est\u00e1 operacional desde dezembro de 2020. Que operadores econ\u00f3micos t\u00eam de se registar na EUDAMED? Fabricantes. Representantes autorizados. Produtores de pacotes de sistemas e procedimentos. Importadores. Os distribuidores n\u00e3o devem registar-se na EUDAMED. Para mais informa\u00e7\u00f5es, tem esta liga\u00e7\u00e3o da Comiss\u00e3o Europeia que detalha os pap\u00e9is dos diferentes agentes econ\u00f3micos: eudamed (europa.eu) Al\u00e9m disso, os importadores s\u00e3o obrigados a realizar verifica\u00e7\u00f5es no EUDAMED: Verificar se o dispositivo m\u00e9dico est\u00e1 registado (artigo 13(4) do MDR). Verifica se o Fabricante e o Representante Autorizado comunicaram as informa\u00e7\u00f5es necess\u00e1rias \u00e0 EUDAMED, no prazo de duas semanas ap\u00f3s a coloca\u00e7\u00e3o do produto no mercado (exceto no caso de produtos feitos por medida) e informa estes agentes quando as informa\u00e7\u00f5es s\u00e3o incorrectas ou insuficientes (RDM, artigo 30.\u00ba, n.\u00ba 3 \/ RIV, artigo 27.\u00ba, n.\u00ba 3 \/ RIV, n.\u00ba 3). Verificar se as suas pr\u00f3prias informa\u00e7\u00f5es cadastrais est\u00e3o completas, precisas e atualizadas com a periodicidade indicada no artigo 31(5) do MDR\/ artigo 28(5) do IVDR. Supplaffairs pode ajudar-te a cumprir as tuas obriga\u00e7\u00f5es de registo na EUDAMED.<\/p>\n","protected":false},"author":2,"featured_media":3065,"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":[6],"tags":[],"class_list":["post-3078","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sem-categoria","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\/pt-pt\/welcome-to-eudamed\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Welcome to EUDAMED - Supplaffairs\" \/>\n<meta property=\"og:description\" content=\"EUDAMED \u00e9 a base de dados, criada pela Comiss\u00e3o Europeia, que visa recolher informa\u00e7\u00f5es relacionadas com os dispositivos m\u00e9dicos comercializados na Europa, de acordo com os requisitos do MDR 2017\/745 e do IVDR 2017\/746, a fim de melhorar a transpar\u00eancia das informa\u00e7\u00f5es sobre estes produtos. A EUDAMED est\u00e1 estruturada em seis m\u00f3dulos interligados, tr\u00eas dos quais est\u00e3o atualmente operacionais: Ator \u2013 registo e gest\u00e3o de utilizadores Base de dados UDI e registo de dispositivos Certificados e Organismos Notificados Investiga\u00e7\u00e3o cl\u00ednica e estudos de desempenho Vigil\u00e2ncia e vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o Vigil\u00e2ncia do mercado O primeiro \u201cActor Registration Module\u201d (Actor (europa.eu)) est\u00e1 operacional desde dezembro de 2020. Que operadores econ\u00f3micos t\u00eam de se registar na EUDAMED? Fabricantes. Representantes autorizados. Produtores de pacotes de sistemas e procedimentos. Importadores. Os distribuidores n\u00e3o devem registar-se na EUDAMED. Para mais informa\u00e7\u00f5es, tem esta liga\u00e7\u00e3o da Comiss\u00e3o Europeia que detalha os pap\u00e9is dos diferentes agentes econ\u00f3micos: eudamed (europa.eu) Al\u00e9m disso, os importadores s\u00e3o obrigados a realizar verifica\u00e7\u00f5es no EUDAMED: Verificar se o dispositivo m\u00e9dico est\u00e1 registado (artigo 13(4) do MDR). Verifica se o Fabricante e o Representante Autorizado comunicaram as informa\u00e7\u00f5es necess\u00e1rias \u00e0 EUDAMED, no prazo de duas semanas ap\u00f3s a coloca\u00e7\u00e3o do produto no mercado (exceto no caso de produtos feitos por medida) e informa estes agentes quando as informa\u00e7\u00f5es s\u00e3o incorrectas ou insuficientes (RDM, artigo 30.\u00ba, n.\u00ba 3 \/ RIV, artigo 27.\u00ba, n.\u00ba 3 \/ RIV, n.\u00ba 3). Verificar se as suas pr\u00f3prias informa\u00e7\u00f5es cadastrais est\u00e3o completas, precisas e atualizadas com a periodicidade indicada no artigo 31(5) do MDR\/ artigo 28(5) do IVDR. 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A EUDAMED est\u00e1 estruturada em seis m\u00f3dulos interligados, tr\u00eas dos quais est\u00e3o atualmente operacionais: Ator \u2013 registo e gest\u00e3o de utilizadores Base de dados UDI e registo de dispositivos Certificados e Organismos Notificados Investiga\u00e7\u00e3o cl\u00ednica e estudos de desempenho Vigil\u00e2ncia e vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o Vigil\u00e2ncia do mercado O primeiro \u201cActor Registration Module\u201d (Actor (europa.eu)) est\u00e1 operacional desde dezembro de 2020. Que operadores econ\u00f3micos t\u00eam de se registar na EUDAMED? Fabricantes. Representantes autorizados. Produtores de pacotes de sistemas e procedimentos. Importadores. Os distribuidores n\u00e3o devem registar-se na EUDAMED. Para mais informa\u00e7\u00f5es, tem esta liga\u00e7\u00e3o da Comiss\u00e3o Europeia que detalha os pap\u00e9is dos diferentes agentes econ\u00f3micos: eudamed (europa.eu) Al\u00e9m disso, os importadores s\u00e3o obrigados a realizar verifica\u00e7\u00f5es no EUDAMED: Verificar se o dispositivo m\u00e9dico est\u00e1 registado (artigo 13(4) do MDR). Verifica se o Fabricante e o Representante Autorizado comunicaram as informa\u00e7\u00f5es necess\u00e1rias \u00e0 EUDAMED, no prazo de duas semanas ap\u00f3s a coloca\u00e7\u00e3o do produto no mercado (exceto no caso de produtos feitos por medida) e informa estes agentes quando as informa\u00e7\u00f5es s\u00e3o incorrectas ou insuficientes (RDM, artigo 30.\u00ba, n.\u00ba 3 \/ RIV, artigo 27.\u00ba, n.\u00ba 3 \/ RIV, n.\u00ba 3). Verificar se as suas pr\u00f3prias informa\u00e7\u00f5es cadastrais est\u00e3o completas, precisas e atualizadas com a periodicidade indicada no artigo 31(5) do MDR\/ artigo 28(5) do IVDR. 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