{"id":892,"date":"2024-06-18T10:17:14","date_gmt":"2024-06-18T10:17:14","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?page_id=892"},"modified":"2026-05-06T14:41:08","modified_gmt":"2026-05-06T14:41:08","slug":"registro-eudamed","status":"publish","type":"page","link":"https:\/\/cmcmedicaldevices.com\/es\/servicios\/registro-eudamed\/","title":{"rendered":"Consultor\u00eda &#8211; Registro EUDAMED"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background fusion-parallax-none nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:150px;--awb-padding-bottom:85px;--awb-background-color:var(--awb-color5);--awb-background-image:linear-gradient(168deg, rgba(6,43,33,0.96) 0%,rgba(6,43,33,0.22) 100%),url(https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/close-up-executive-man-hands-answering-negotiations-email-planning-business-company-consultation-late-night-startup-office-3000x1503.webp);;--awb-background-size:cover;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-space-between fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_3_5 3_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:60%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.2%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.2%;--awb-width-medium:80%;--awb-order-medium:0;--awb-spacing-right-medium:2.4%;--awb-spacing-left-medium:2.4%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-margin-bottom:10px;--awb-max-width:30px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none fusion-animated\" data-animationType=\"rubberBand\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><img decoding=\"async\" width=\"2560\" height=\"2477\" title=\"ISOTIPO CMC MEDICAL DEVICES_AZUL\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp\" alt class=\"img-responsive wp-image-17\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-200x194.webp 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-400x387.webp 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-600x581.webp 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-768x743.webp 768w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-800x774.webp 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1200x1161.webp 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1536x1486.webp 1536w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp 2560w\" sizes=\"(max-width: 640px) 100vw, 800px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one fusion-animated\" style=\"--awb-text-color:var(--awb-color3);--awb-font-size:20px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><h1 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather Sans&quot;;font-style:normal;font-weight:300;margin:0;font-size:1em;text-transform:uppercase;--fontSize:20;--minFontSize:20;line-height:var(--awb-typography1-line-height);\"><span data-sheets-root=\"1\">Consultor\u00eda para Registro en EUDAMED<\/span><\/h1><\/div><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-two fusion-animated\" style=\"--awb-text-color:var(--awb-color4);--awb-margin-right:10%;--awb-margin-bottom:20px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:40;line-height:var(--awb-typography1-line-height);\"><div class=\"page\" title=\"Page 2\">\n<div class=\"section\">\n<div class=\"layoutArea\">\n<div class=\"column\"><span data-sheets-root=\"1\">CMC Medical Devices ofrece Registro de Productos Sanitarios en EUDAMED<\/span><\/div>\n<\/div>\n<\/div>\n<\/div><\/h2><\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-button-default-type awb-b-icon-pos-right\" style=\"--button_accent_color:var(--awb-color3);--button_border_color:var(--awb-color4);--button_accent_hover_color:var(--awb-color3);--button_border_hover_color:var(--awb-color3);--button_gradient_top_color:rgba(0,0,0,0);--button_gradient_bottom_color:rgba(0,0,0,0);--button_gradient_top_color_hover:rgba(0,0,0,0);--button_gradient_bottom_color_hover:rgba(0,0,0,0);--button_font_size:16px;--button_padding-left:8px;--button_typography-font-family:&quot;Merriweather Sans&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-bottom:0px;\" target=\"_self\" data-hover=\"icon_position\" href=\"#contact\"><span class=\"fusion-button-text\">Contacta con nosotros<\/span><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><\/a><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:var(--awb-color5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:70px;--awb-padding-bottom:75px;--awb-background-color:var(--awb-color4);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-space-between fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_2_3 2_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:66.666666666667%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.88%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:2.88%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-paragraph\" style=\"--awb-margin-bottom:0px;\"><p class=\"fusion-title-heading title-heading-left title-heading-tag fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:15;--minFontSize:15;line-height:1.5;\">CMC apoya a los fabricantes en la obtenci\u00f3n del registro EUDAMED para productos sanitarios y productos sanitarios para diagn\u00f3stico in vitro (IVD) en la Uni\u00f3n Europea.<\/p><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:rgba(197,252,84,0.5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:75px;--awb-padding-bottom:85px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-color3);\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:40;line-height:var(--awb-typography1-line-height);\">Registro de EUDAMED<\/h2><\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-2 fusion-button-default-span fusion-button-default-type awb-b-icon-pos-right\" style=\"--button_accent_color:var(--awb-color3);--button_border_color:var(--awb-color4);--button_accent_hover_color:var(--awb-color3);--button_border_hover_color:var(--awb-color3);--button_gradient_top_color:rgba(0,0,0,0);--button_gradient_bottom_color:rgba(0,0,0,0);--button_gradient_top_color_hover:rgba(0,0,0,0);--button_gradient_bottom_color_hover:rgba(0,0,0,0);--button_font_size:16px;--button_padding-left:8px;--button_typography-font-family:&quot;Merriweather Sans&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-bottom:20px;\" target=\"_self\" data-hover=\"icon_position\" href=\"https:\/\/cmcmedicaldevices.com\/es\/servicios\/registro-eudamed\/#contact\"><span class=\"fusion-button-text\">Contacta con nosotros<\/span><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><\/a><\/div><div class=\"fusion-separator\" style=\"align-self: flex-start;margin-right:auto;margin-bottom:30px;width:100%;max-width:200px;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-margin-bottom-small:20px;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-text-color:var(--awb-color4);\"><p>El registro EUDAMED es obligatorio desde el 2\u202fde\u202fmayo\u202fde\u202f2026, conforme al Reglamento (UE) 2017\/745 (MDR) y 2017\/746 (IVDR). Este registro garantiza que los productos cumplan con los requisitos regulatorios de la UE, incluyendo el registro obligatorio de UDI (Identificaci\u00f3n \u00danica del Dispositivo) y de informaci\u00f3n del dispositivo, permitiendo que puedan comercializarse legalmente en la UE.<span style=\"background-color: rgba(0, 0, 0, 0);\"><\/span><\/p>\n<p><span style=\"background-color: rgba(0, 0, 0, 0);\">CMC puede gestionar el registro EUDAMED ya sea como su Representante Autorizado en la UE (EU REP) o sin ser su EU REP, ofreciendo flexibilidad seg\u00fan su caso y necesidad.<\/span><\/p>\n<p>Los dispositivos comercializados en la UE antes del 28\u202fde\u202fmayo\u202fde\u202f2026 deber\u00e1n registrarse antes del 28\u202fde\u202fnoviembre\u202fde\u202f2026 seg\u00fan las disposiciones transitorias. Con la experiencia de CMC, podr\u00e1 garantizar un proceso de registro fluido y conforme, asegurando el acceso al mercado europeo.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-5 fusion-sep-none fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color3);--awb-margin-top:0px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:24;line-height:var(--awb-typography1-line-height);\">Nuestros servicios incluyen:<\/h4><\/div><ul style=\"--awb-iconcolor:var(--awb-color3);--awb-textcolor:var(--awb-color4);--awb-line-height:27.2px;--awb-icon-width:27.2px;--awb-icon-height:27.2px;--awb-icon-margin:11.2px;--awb-content-margin:38.4px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Preparaci\u00f3n y env\u00edo de los datos de registro a EUDAMED, incluyendo los m\u00f3dulos de Actores y UDI\/Dispositivos.<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Actuar como punto de contacto local ante las autoridades regulatorias si es necesario.<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Asistencia con actualizaciones, renovaciones y comunicaci\u00f3n con EUDAMED.<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Soporte para la presentaci\u00f3n de datos UDI y del dispositivo cumpliendo con los requisitos de EUDAMED.<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><div id=\"contact\" class=\"fusion-container-anchor\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-4 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-top:1px;--awb-border-sizes-bottom:1px;--awb-border-color:var(--awb-color4);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:80px;--awb-padding-bottom:100px;--awb-padding-top-small:65px;--awb-padding-bottom-small:50px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_2_5 2_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:40%;--awb-margin-top-large:0px;--awb-spacing-right-large:4.8%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:4.8%;--awb-width-medium:40%;--awb-order-medium:0;--awb-spacing-right-medium:4.8%;--awb-spacing-left-medium:4.8%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-margin-bottom-small:50px;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_1_1 1_1 fusion-flex-column fusion-no-small-visibility\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-motion-effects=\"[{&quot;type&quot;:&quot;infinite&quot;,&quot;scroll_type&quot;:&quot;rotate&quot;,&quot;infinite_animation&quot;:&quot;float&quot;,&quot;infinite_animation_speed&quot;:&quot;2.0&quot;}]\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"text-align:right;--awb-margin-left:5px;--awb-max-width:40px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-2 hover-type-none fusion-animated\" data-animationType=\"rubberBand\" data-animationDuration=\"1.0\" data-animationDelay=\"0.1\" data-animationOffset=\"top-into-view\"><img decoding=\"async\" width=\"2560\" height=\"2477\" title=\"ISOTIPO CMC MEDICAL DEVICES_AZUL\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp\" alt class=\"img-responsive wp-image-17\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-200x194.webp 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-400x387.webp 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-600x581.webp 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-768x743.webp 768w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-800x774.webp 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1200x1161.webp 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1536x1486.webp 1536w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp 2560w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><div class=\"fusion-title title fusion-title-6 fusion-sep-none fusion-title-text fusion-title-size-two fusion-animated\" style=\"--awb-text-color:var(--awb-color4);--awb-margin-bottom:30px;--awb-margin-bottom-small:20px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather&quot;;font-style:normal;font-weight:300;margin:0;--fontSize:40;line-height:var(--awb-typography1-line-height);\">Elige CMC para validar tu registro de actor en EUDAMED<\/h2><\/div><div class=\"fusion-text fusion-text-2 fusion-animated fusion-text-no-margin\" style=\"--awb-text-color:var(--awb-color3);--awb-margin-bottom:30px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationDelay=\"0.3\" data-animationOffset=\"top-into-view\"><p>Completa el formulario de contacto y uno de nuestros consultores se pondr\u00e1 en contacto lo antes posible.<\/p>\n<\/div><div class=\"fusion-social-links fusion-social-links-1\" style=\"--awb-margin-top:30px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;--awb-box-border-top:0px;--awb-box-border-right:0px;--awb-box-border-bottom:0px;--awb-box-border-left:0px;--awb-icon-colors-hover:var(--awb-color3);--awb-box-colors-hover:var(--awb-color1);--awb-box-border-color:var(--awb-color3);--awb-box-border-color-hover:var(--awb-color4);\"><div class=\"fusion-social-networks color-type-custom\"><div class=\"fusion-social-networks-wrapper\"><a class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:var(--awb-color4);font-size:17px;\" title=\"Facebook\" aria-label=\"facebook\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.facebook.com\/profile.php?id=61561382190867\"><\/a><a class=\"fusion-social-network-icon fusion-tooltip fusion-instagram awb-icon-instagram\" style=\"color:var(--awb-color4);font-size:17px;\" title=\"Instagram\" aria-label=\"instagram\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.instagram.com\/cmc_medical_devices\/\"><\/a><a class=\"fusion-social-network-icon fusion-tooltip fusion-linkedin awb-icon-linkedin\" style=\"color:var(--awb-color4);font-size:17px;\" title=\"LinkedIn\" aria-label=\"linkedin\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.linkedin.com\/company\/cmc-medical-devices-consulting\/?viewAsMember=true\"><\/a><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_3_5 3_5 fusion-flex-column fusion-animated\" style=\"--awb-overflow:hidden;--awb-bg-size:cover;--awb-border-color:var(--awb-color4);--awb-border-style:solid;--awb-border-radius:20px 20px 20px 20px;--awb-width-large:60%;--awb-margin-top-large:70px;--awb-spacing-right-large:3.2%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:8%;--awb-width-medium:60%;--awb-order-medium:0;--awb-spacing-right-medium:3.2%;--awb-spacing-left-medium:8%;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:0px;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-animationType=\"fadeInRight\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\">\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f4059-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"4059\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/es\/wp-json\/wp\/v2\/pages\/892#wpcf7-f4059-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"4059\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.1\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f4059-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"your-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Nombre*\" value=\"\" type=\"text\" name=\"your-name\" \/><\/span>\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Email*\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span>\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"telefono\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-tel\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Tel\u00e9fono*\" value=\"\" type=\"tel\" name=\"telefono\" \/><\/span>\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"mensaje\"><textarea cols=\"40\" rows=\"10\" maxlength=\"2000\" class=\"wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"\u00bfC\u00f3mo podemos ayudarte?*\" name=\"mensaje\"><\/textarea><\/span>\n<\/p>\n<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Enviar\" \/>\n<\/p><div class=\"fusion-alert alert custom alert-custom fusion-alert-center wpcf7-response-output awb-alert-native-link-color alert-dismissable awb-alert-close-boxed\" style=\"--awb-border-size:1px;--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"fusion-alert-content\"><\/span><\/div><button type=\"button\" class=\"close toggle-alert\" data-dismiss=\"alert\" aria-label=\"Close\">&times;<\/button><\/div>\n<\/form>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-5 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:var(--awb-color5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:20px;--awb-padding-bottom:10px;--awb-background-color:var(--awb-color4);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-space-between fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_5 1_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:9.6%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:9.6%;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:9.6%;--awb-spacing-left-medium:9.6%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-max-width:150px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-3 hover-type-none fusion-animated\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.3\" data-animationOffset=\"top-into-view\"><img decoding=\"async\" width=\"2560\" height=\"2477\" title=\"ISOTIPO CMC MEDICAL DEVICES_VERDE\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-scaled.webp\" alt class=\"img-responsive wp-image-19\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-200x194.webp 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-400x387.webp 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-600x581.webp 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-768x743.webp 768w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-800x774.webp 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-1200x1161.webp 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-1536x1486.webp 1536w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-scaled.webp 2560w\" sizes=\"(max-width: 640px) 100vw, 200px\" \/><\/span><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_4_5 4_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:80%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.4%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:2.4%;--awb-width-medium:80%;--awb-order-medium:0;--awb-spacing-right-medium:2.4%;--awb-spacing-left-medium:2.4%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-7 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-font-size:35px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather&quot;;font-style:normal;font-weight:400;margin:0;font-size:1em;--fontSize:35;line-height:var(--awb-typography1-line-height);\"><span data-sheets-root=\"1\">Preguntas frecuentes sobre el registro en EUDAMED<\/span><\/h2><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-6 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:rgba(197,252,84,0.5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:75px;--awb-padding-bottom:85px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-9 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"accordian fusion-accordian\" style=\"--awb-padding-top:10px;--awb-padding-bottom:10px;--awb-border-size:1px;--awb-icon-size:16px;--awb-content-font-size:var(--awb-typography4-font-size);--awb-icon-alignment:left;--awb-hover-color:var(--awb-color2);--awb-border-color:var(--awb-color3);--awb-background-color:var(--awb-color1);--awb-divider-color:var(--awb-color3);--awb-divider-hover-color:var(--awb-color3);--awb-icon-color:var(--awb-color1);--awb-title-color:var(--awb-color3);--awb-content-color:var(--awb-color4);--awb-icon-box-color:var(--awb-color4);--awb-toggle-hover-accent-color:var(--awb-color4);--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:16px;--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;\"><div class=\"panel-group fusion-toggle-icon-unboxed\" id=\"accordion-892-1\"><div class=\"fusion-panel panel-default panel-4cd960bd6537434ed fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_4cd960bd6537434ed\"><a aria-expanded=\"false\" aria-controls=\"4cd960bd6537434ed\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-892-1\" data-target=\"#4cd960bd6537434ed\" href=\"#4cd960bd6537434ed\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfQui\u00e9n debe registrarse en EUDAMED?<\/span><\/a><\/h3><\/div><div id=\"4cd960bd6537434ed\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_4cd960bd6537434ed\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">Los operadores econ\u00f3micos que deben registrarse en EUDAMED incluyen:<\/span><\/p>\n<p><span data-sheets-root=\"1\">Importadores.<\/span><\/p>\n<p><span data-sheets-root=\"1\">Fabricantes de la UE y de fuera de la UE.<\/span><\/p>\n<p><span data-sheets-root=\"1\">Productores de sistemas y paquetes de procedimientos.<\/span><\/p>\n<p><span data-sheets-root=\"1\">Representantes autorizados.<\/span><\/p>\n<p><span data-sheets-root=\"1\">Adem\u00e1s, los Estados Miembros, organismos notificados y promotores tambi\u00e9n deben ingresar datos en la base de datos.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-42d4bab89217b2749 fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_42d4bab89217b2749\"><a aria-expanded=\"false\" aria-controls=\"42d4bab89217b2749\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-892-1\" data-target=\"#42d4bab89217b2749\" href=\"#42d4bab89217b2749\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfEs obligatorio registrarse en EUDAMED?<\/span><\/a><\/h3><\/div><div id=\"42d4bab89217b2749\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_42d4bab89217b2749\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">Aunque el registro en EUDAMED no es actualmente obligatorio, se recomienda encarecidamente que los fabricantes se registren como actores y registren sus dispositivos. Algunas autoridades competentes est\u00e1n considerando eliminar la obligaci\u00f3n de notificaci\u00f3n nacional para productos registrados en EUDAMED.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-bc7137fe0bd0457d6 fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_bc7137fe0bd0457d6\"><a aria-expanded=\"false\" aria-controls=\"bc7137fe0bd0457d6\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-892-1\" data-target=\"#bc7137fe0bd0457d6\" href=\"#bc7137fe0bd0457d6\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfCu\u00e1l es el proceso para registrarse en EUDAMED?<\/span><\/a><\/h3><\/div><div id=\"bc7137fe0bd0457d6\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_bc7137fe0bd0457d6\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">Los fabricantes deben primero registrarse como actores y luego proceder al registro del dispositivo. Para registrarse, los fabricantes deben:<\/span><\/p>\n<p><span data-sheets-root=\"1\">Crear una cuenta y completar la informaci\u00f3n requerida.<\/span><\/p>\n<p><span data-sheets-root=\"1\">Asegurar que los dispositivos cumplan con la legislaci\u00f3n aplicable (MDR\/IVDR).<\/span><\/p>\n<p><span data-sheets-root=\"1\">Para fabricantes fuera de la UE, firmar un mandato con el representante autorizado.<\/span><\/p>\n<p><span data-sheets-root=\"1\">Completar el registro de actor y posteriormente ingresar la informaci\u00f3n del dispositivo en el m\u00f3dulo correspondiente, siguiendo la Gu\u00eda de Usuario proporcionada por la Comisi\u00f3n de la UE.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-20a28fb282527327d fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_20a28fb282527327d\"><a aria-expanded=\"false\" aria-controls=\"20a28fb282527327d\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-892-1\" data-target=\"#20a28fb282527327d\" href=\"#20a28fb282527327d\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfC\u00f3mo se verifica el registro de un fabricante fuera de la UE?<\/span><\/a><\/h3><\/div><div id=\"20a28fb282527327d\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_20a28fb282527327d\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">Despu\u00e9s de completar el registro, el Representante Autorizado debe verificar el registro del UDI y la informaci\u00f3n del dispositivo en EUDAMED. El primer registro es el de actor, en el cual los fabricantes deben proporcionar datos sobre su empresa, como direcci\u00f3n, informaci\u00f3n de la persona responsable de regulaciones y detalles de identificaci\u00f3n de la empresa. Posteriormente, el Representante Autorizado validar\u00e1 el registro antes de que la Autoridad Competente lo valide. Con este registro, los fabricantes recibir\u00e1n el n\u00famero SRN, requerido por los organismos notificados en el procedimiento de evaluaci\u00f3n de conformidad.<\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-7 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:rgba(197,252,84,0.5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-bottom:0px;--awb-margin-bottom:0px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-10 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-8 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-color3);--awb-margin-top:50px;--awb-margin-top-small:30px;--awb-font-size:28px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather&quot;;font-style:normal;font-weight:400;margin:0;font-size:1em;--fontSize:28;line-height:var(--awb-typography1-line-height);\"><span data-sheets-root=\"1\">Facilitamos el proceso de registro en EUDAMED para fabricantes y sus productos<\/span><\/h2><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-11 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-1 fusion-content-boxes-1 content-boxes-icon-on-top content-left\" style=\"--awb-body-color:var(--awb-color4);--awb-title-color:var(--awb-color4);--awb-margin-bottom:20px;--awb-hover-accent-color:var(--awb-color4);--awb-circle-hover-accent-color:transparent;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);--awb-iconcolor:var(--awb-color4);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-none\" data-animationOffset=\"top-into-view\"><div class=\"heading heading-with-icon icon-left\"><div class=\"icon\"><i style=\"background-color:transparent;border-color:transparent;height:auto;width: 34px;line-height:normal;font-size:34px;\" aria-hidden=\"true\" class=\"fontawesome-icon fa-envelope-open fas circle-no\"><\/i><\/div><p class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--body_typography-font-size:24px;--fontSize:24;line-height:1.5;\">Respuesta r\u00e1pida <\/p><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Atendemos de manera r\u00e1pida y eficiente cualquier consulta de las autoridades o cuerpos regulatorios en los pa\u00edses donde operamos.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-12 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-1 fusion-content-boxes-2 content-boxes-icon-on-top content-left\" style=\"--awb-body-color:var(--awb-color4);--awb-title-color:var(--awb-color4);--awb-margin-bottom:20px;--awb-hover-accent-color:var(--awb-color4);--awb-circle-hover-accent-color:transparent;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);--awb-iconcolor:var(--awb-color4);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-none\" data-animationOffset=\"top-into-view\"><div class=\"heading heading-with-icon icon-left\"><div class=\"icon\"><i style=\"background-color:transparent;border-color:transparent;height:auto;width: 34px;line-height:normal;font-size:34px;\" aria-hidden=\"true\" class=\"fontawesome-icon fa-envelope-open fas circle-no\"><\/i><\/div><p class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--body_typography-font-size:24px;--fontSize:24;line-height:1.5;\">Comunicaci\u00f3n eficiente<\/p><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Nuestro equipo ofrece respuestas r\u00e1pidas y claras a cualquier pregunta o inquietud, minimizando demoras y garantizando un proceso de aprobaci\u00f3n sin contratiempos.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-13 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-1 fusion-content-boxes-3 content-boxes-icon-on-top content-left\" style=\"--awb-body-color:var(--awb-color4);--awb-title-color:var(--awb-color4);--awb-margin-bottom:20px;--awb-hover-accent-color:var(--awb-color4);--awb-circle-hover-accent-color:transparent;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);--awb-iconcolor:var(--awb-color4);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-none\" data-animationOffset=\"top-into-view\"><div class=\"heading heading-with-icon icon-left\"><div class=\"icon\"><i style=\"background-color:transparent;border-color:transparent;height:auto;width: 34px;line-height:normal;font-size:34px;\" aria-hidden=\"true\" class=\"fontawesome-icon fa-user-clock fas circle-no\"><\/i><\/div><p class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--body_typography-font-size:24px;--fontSize:24;line-height:1.5;\">Soporte inmediato <\/p><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Gestionamos consultas y solicitudes tanto de fabricantes como de organismos regulatorios con velocidad y precisi\u00f3n.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-14 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-1 fusion-content-boxes-4 content-boxes-icon-on-top content-left\" style=\"--awb-body-color:var(--awb-color4);--awb-title-color:var(--awb-color4);--awb-margin-bottom:20px;--awb-hover-accent-color:var(--awb-color4);--awb-circle-hover-accent-color:transparent;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);--awb-iconcolor:var(--awb-color4);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-none\" data-animationOffset=\"top-into-view\"><div class=\"heading heading-with-icon icon-left\"><div class=\"icon\"><i style=\"background-color:transparent;border-color:transparent;height:auto;width: 34px;line-height:normal;font-size:34px;\" aria-hidden=\"true\" class=\"fontawesome-icon fa-cogs fas circle-no\"><\/i><\/div><p class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--body_typography-font-size:24px;--fontSize:24;line-height:1.5;\">Resoluci\u00f3n r\u00e1pida <\/p><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Cualquier pregunta de cumplimiento o necesidad de documentaci\u00f3n se aborda de inmediato, asegurando que su producto avance a trav\u00e9s del proceso regulatorio de la manera m\u00e1s r\u00e1pida y fluida posible.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":660,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-892","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Registro de Dispositivos M\u00e9dicos en EUDAMED<\/title>\n<meta name=\"description\" content=\"Servicios de consultor\u00eda experta para el registro en EUDAMED. 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