{"id":6885,"date":"2019-02-27T18:13:47","date_gmt":"2019-02-27T17:13:47","guid":{"rendered":"https:\/\/productosanitario.es\/medical-device-technical-file\/"},"modified":"2025-03-06T15:36:35","modified_gmt":"2025-03-06T14:36:35","slug":"medical-device-technical-file","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/medical-device-technical-file\/","title":{"rendered":"Medical device technical file"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6885\" class=\"elementor elementor-6885 elementor-2797\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7a8e759 e-con-full e-flex e-con e-parent\" data-id=\"7a8e759\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-a825c98 e-con-full e-flex e-con e-child\" data-id=\"a825c98\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-37975bc elementor-widget elementor-widget-heading\" data-id=\"37975bc\" 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 <b>device<\/b> technical file<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17aee31 elementor-widget elementor-widget-text-editor\" data-id=\"17aee31\" 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<p>The <a href=\"https:\/\/www.productosanitario.es\/producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">technical product<\/a> documentation, or <a href=\"https:\/\/productosanitario.es\/en\/medical-device-technical-file\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Medical Device Technical File<\/a> , must be prepared by the manufacturer in a clear, organized, easy-to-search and unambiguous manner, including, at least:<\/p><ul><li>Product description and specifications, including variants and accessories.<\/li><li>Information to be provided by the manufacturer (label and instructions for use).<\/li><li>Design and manufacturing information.<\/li><li><a href=\"https:\/\/productosanitario.es\/requisitos-esenciales-de-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">General <\/a>safety and operational requirements.<\/li><li><a href=\"https:\/\/productosanitario.es\/category\/gestion-de-riesgos-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Risk management<\/a>.<\/li><li>Product verification and validation.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0ab8345 e-con-full e-flex e-con e-child\" data-id=\"0ab8345\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4fe920d e-flex e-con-boxed e-con e-parent\" data-id=\"4fe920d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b077a3a e-con-full e-flex e-con e-child\" data-id=\"b077a3a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f4bd981 e-con-full e-flex e-con e-child\" data-id=\"f4bd981\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-223808c elementor-widget elementor-widget-text-editor\" data-id=\"223808c\" 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<p>The basis and content of the <a href=\"https:\/\/www.productosanitario.es\/expediente-tecnico-del-producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Technical File<\/a> is regulated by the <a href=\"https:\/\/www.productosanitario.es\/blog\/normativa-armonizada\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">harmonised<\/a> <a href=\"https:\/\/productosanitario.es\/category\/mdr-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">legislation<\/a> and regulations that apply to it, including all the information relating to the product, from its earliest design phases to the <a href=\"https:\/\/productosanitario.es\/category\/mdr-producto-sanitario\/control-del-mercado-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">post-marketing monitoring<\/a> required by legislation. As an essential element of the technical file, the list of general safety and operational requirements is documented. <\/p><p>It is the responsibility of the <a href=\"https:\/\/productosanitario.es\/category\/mdr-producto-sanitario\/control-del-mercado-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Technical Manager<\/a> to maintain and preserve this information, making it available to the competent Authorities when required.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\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-634b72e e-flex e-con-boxed e-con e-parent\" data-id=\"634b72e\" 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-e2b0901 elementor-widget elementor-widget-heading\" data-id=\"e2b0901\" data-element_type=\"widget\" data-e-type=\"widget\" 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elementor-widget-heading\" data-id=\"cf19537\" 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\">Contact<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0174c9 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"c0174c9\" 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<p>Write to us at<br><a href=\"mailto:info@productosanitario.es\"><span style=\"text-decoration: underline; color: #ffffff;\">info@productosanitario.es<\/span><\/a> <br>voice call or Whatsapp<br><span style=\"color: #ffffff;\">+34 669 27 21 63<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bb888e6 e-con-full e-flex e-con e-child\" data-id=\"bb888e6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b86b8c1 elementor-widget elementor-widget-heading\" data-id=\"b86b8c1\" 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\">or fill out our form.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17df433 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"17df433\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" 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Information to be provided by the manufacturer (label and instructions for use). Design and manufacturing information. [&hellip;]<\/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-6885","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical device technical file - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"The medical device technical file is the set of documents that contain the specifications and requirements of the product\" \/>\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-technical-file\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical device technical file - 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