{"id":6913,"date":"2019-01-24T08:48:01","date_gmt":"2019-01-24T07:48:01","guid":{"rendered":"https:\/\/productosanitario.es\/medical-device\/"},"modified":"2025-03-06T15:44:36","modified_gmt":"2025-03-06T14:44:36","slug":"medical-device","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/medical-device\/","title":{"rendered":"Medical Device"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6913\" class=\"elementor elementor-6913 elementor-1895\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-94bc983 e-flex e-con-boxed e-con e-parent\" data-id=\"94bc983\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1bca656 elementor-widget__width-inherit elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"1bca656\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Medical Device<\/h1>\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<div class=\"elementor-element elementor-element-5992f5e e-flex e-con-boxed e-con e-parent\" data-id=\"5992f5e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<a class=\"elementor-element elementor-element-74ea2b5 e-con-full e-flex e-con e-child\" data-id=\"74ea2b5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/responsable-tecnico-de-producto-sanitario\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d13df98 elementor-widget elementor-widget-heading\" data-id=\"d13df98\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Medical Device Technical Manager<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-8bc2a6f e-con-full e-flex e-con e-child\" data-id=\"8bc2a6f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/requisitos-esenciales-de-producto-sanitario\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a4b8f94 elementor-widget elementor-widget-heading\" data-id=\"a4b8f94\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Essential medical device requirements<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-57bb198 e-con-full e-flex e-con e-child\" data-id=\"57bb198\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/aemps\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a3d7fe elementor-widget elementor-widget-heading\" data-id=\"2a3d7fe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">AEMPS<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-fc78fad e-con-full e-flex e-con e-child\" data-id=\"fc78fad\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/finalidad-prevista\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fa46bb3 elementor-widget elementor-widget-heading\" data-id=\"fa46bb3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Intended purpose<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-e9c0e23 e-con-full e-flex e-con e-child\" data-id=\"e9c0e23\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/comunicacion-de-puesta-en-el-mercado\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9d86366 elementor-widget elementor-widget-heading\" data-id=\"9d86366\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Placing on the market communication<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-f057015 e-con-full e-flex e-con e-child\" data-id=\"f057015\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/expediente-tecnico-del-producto-sanitario\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b781fe9 elementor-widget elementor-widget-heading\" data-id=\"b781fe9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Medical device technical file<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-7f7b218 e-con-full e-flex e-con e-child\" data-id=\"7f7b218\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/sistema-de-vigilancia\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ba167a1 elementor-widget elementor-widget-heading\" data-id=\"ba167a1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Surveillance system<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-77b52b9 e-con-full e-flex e-con e-child\" data-id=\"77b52b9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/declaracion-de-conformidad\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0a2c04e elementor-widget elementor-widget-heading\" data-id=\"0a2c04e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Declaration of conformity<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-7674c91 e-con-full e-flex e-con e-child\" data-id=\"7674c91\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/procedimientos-de-evaluacion-de-producto-sanitario\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-30c921e elementor-widget elementor-widget-heading\" data-id=\"30c921e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Evaluation procedures<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-b255796 e-con-full e-flex e-con e-child\" data-id=\"b255796\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/marcado-ce\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d6196e elementor-widget elementor-widget-heading\" data-id=\"1d6196e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">CE marking<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-b010cce e-con-full e-flex e-con e-child\" data-id=\"b010cce\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/licencia-previa-de-funcionamiento-de-producto-sanitario\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2bb2c3d elementor-widget elementor-widget-heading\" data-id=\"2bb2c3d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Pre-Operating License<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-ebfe7d2 e-con-full e-flex e-con e-child\" data-id=\"ebfe7d2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/tipo-de-producto-sanitario\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fe02c7b elementor-widget elementor-widget-heading\" data-id=\"fe02c7b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Type of medical device<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-02ac523 e-con-full e-flex e-con e-child\" data-id=\"02ac523\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/productosanitario.es\/organismos-notificados-producto-sanitario\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c9522bb elementor-widget elementor-widget-heading\" data-id=\"c9522bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Notified bodies for medical devices<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/a>\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>Medical Device Medical Device Technical Manager Essential medical device requirements AEMPS Intended purpose Placing on the market communication Medical device technical file Surveillance system Declaration of conformity Evaluation procedures CE marking Pre-Operating License Type of medical device Notified bodies for medical devices<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6913","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Device - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"A medical device is a product that aims to provide a clinical benefit to its users, in relation to an illness, injury or disability\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/productosanitario.es\/en\/medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device - 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