{"id":6911,"date":"2019-02-27T18:17:21","date_gmt":"2019-02-27T17:17:21","guid":{"rendered":"https:\/\/productosanitario.es\/medical-device-evaluation-procedures\/"},"modified":"2025-03-06T15:44:11","modified_gmt":"2025-03-06T14:44:11","slug":"medical-device-evaluation-procedures","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/medical-device-evaluation-procedures\/","title":{"rendered":"Medical device evaluation procedures"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6911\" class=\"elementor elementor-6911 elementor-2807\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a3a013 e-con-full e-flex e-con e-parent\" data-id=\"2a3a013\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-3c7aa67 e-con-full e-flex e-con e-child\" data-id=\"3c7aa67\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e2564be elementor-widget elementor-widget-heading\" data-id=\"e2564be\" 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\"><b>Medical device<\/b> evaluation procedures<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34328bd elementor-widget elementor-widget-text-editor\" data-id=\"34328bd\" 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>Manufacturers shall carry out an <a href=\"https:\/\/productosanitario.es\/en\/medical-device-evaluation-procedures\/\" target=\"_blank\" rel=\"noopener\">assessment of the conformity of the product<\/a> prior to <a href=\"https:\/\/productosanitario.es\/en\/placing-on-the-market-communication\/\" target=\"_blank\" rel=\"noopener\">placing on the market<\/a>.<\/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-f6b5944 e-con-full e-flex e-con e-child\" data-id=\"f6b5944\" 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-39500cb e-flex e-con-boxed e-con e-parent\" data-id=\"39500cb\" 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-5ec4efe e-con-full e-flex e-con e-child\" data-id=\"5ec4efe\" 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-41e7324 e-con-full e-flex e-con e-child\" data-id=\"41e7324\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a828296 elementor-widget elementor-widget-text-editor\" data-id=\"a828296\" 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>In accordance with the following evaluation procedures:<\/p><ul><li>Based on a <a href=\"https:\/\/productosanitario.es\/category\/iso-13485-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">quality management<\/a> system and the evaluation of <a href=\"https:\/\/productosanitario.es\/en\/technical-documentation\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">technical documentation<\/a>: The manufacturer will implement, and maintain it throughout the life cycle of the product, a quality management system, subject to Audit by the selected Notified Body.<ul><li>The application of the quality management system will guarantee compliance with the legislation applicable to the manufactured product.<\/li><li>The <a href=\"https:\/\/www.productosanitario.es\/organismos-notificados-producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Notified Body<\/a> will carry out a complete review, by personnel with sufficient experience and knowledge, to ensure that the product <a href=\"https:\/\/productosanitario.es\/en\/declaration-of-conformity\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">conformity<\/a> assessment is compliant and sufficient and that it has been documented in accordance with the applicable requirements.<\/li><\/ul><\/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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-99c14b2 e-flex e-con-boxed e-con e-parent\" data-id=\"99c14b2\" 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-d5ab91d elementor-widget elementor-widget-text-editor\" data-id=\"d5ab91d\" 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<ul><li>Type-Examined-Based: A procedure by which a <a href=\"https:\/\/productosanitario.es\/en\/notified-bodies-medical-devices\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Notified Body<\/a> checks and certifies that a product, including its <a href=\"https:\/\/productosanitario.es\/en\/technical-documentation\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">technical documentation<\/a>, its relevant processes during the life cycle of the product, and a corresponding representative sample of production, complies with the relevant legally established provisions.<ul><li>The manufacturer shall apply in writing to the <a href=\"https:\/\/www.productosanitario.es\/organismos-notificados-producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Notified Body<\/a> for its request.<\/li><li>The Notified Body will review the application by personnel with knowledge and experience in the technology and <a href=\"https:\/\/www.productosanitario.es\/finalidad-prevista\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">intended purpose<\/a>. It will examine the <a href=\"https:\/\/productosanitario.es\/en\/technical-documentation\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">technical documentation <\/a>to ensure compliance with the applicable legislation. <\/li><li>Review the <a href=\"https:\/\/evaluacionclinica.es\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">clinical evaluation<\/a> report.<\/li><li>It will document its conclusions by means of a report, in a report of the preclinical and clinical evaluation.<\/li><li>It shall carry out or cause to be carried out the tests necessary to confirm compliance with the <a href=\"https:\/\/productosanitario.es\/category\/producto-sanitario\/requisitos-generales-rgsf\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">General Requirements<\/a>.<\/li><li>It shall carry out the necessary tests to confirm that the <a href=\"https:\/\/productosanitario.es\/blog\/normativa-armonizada\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Harmonised Standard<\/a> selected by the manufacturer is suitable.<\/li><li>Draw up the type EU examination report.<\/li><\/ul><\/li><li>Based on the verification of <a href=\"https:\/\/productosanitario.es\/en\/declaration-of-conformity\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">product conformity<\/a>: It aims to guarantee that the products are compliant for the type for which the <a href=\"https:\/\/www.productosanitario.es\/marcado-ce\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">CE Marking<\/a> certificate has been issued. Once the EU examination certificate has been issued, the manufacturer may apply the production quality assurance procedure or the product verification procedure: <ul><li>Production quality assurance: The manufacturer shall ensure that the approved quality management system is in place and shall be subject to appropriate monitoring.<\/li><li>Product verification: This is the procedure by which, after examining each manufactured product, the manufacturer issues an <a href=\"https:\/\/www.productosanitario.es\/declaracion-de-conformidad\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">EU declaration of conformity<\/a>, guaranteeing and declaring that the products have undergone the appropriate procedure and are in conformity with the type defined in the certificate issued by the <a href=\"https:\/\/www.productosanitario.es\/organismos-notificados-producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Notified Body<\/a>.<\/li><\/ul><\/li><\/ul>\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<div class=\"elementor-element elementor-element-9017bba e-flex e-con-boxed e-con e-parent\" data-id=\"9017bba\" 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-c49c814 elementor-widget elementor-widget-heading\" data-id=\"c49c814\" 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\">Blog<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d0e1070 elementor-grid-tablet-3 elementor-widget__width-inherit elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"d0e1070\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:6945,&quot;columns_tablet&quot;:3,&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:20,&quot;sizes&quot;:[]},&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-loop-nothing-found-message\">\n\t\t<\/div>\n\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<div class=\"elementor-element elementor-element-34e14a7 e-flex e-con-boxed e-con e-parent\" data-id=\"34e14a7\" 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-3e4e695 elementor-widget elementor-widget-shortcode\" data-id=\"3e4e695\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">\t\t<div data-elementor-type=\"section\" data-elementor-id=\"6931\" class=\"elementor elementor-6931 elementor-5834 elementor-5834\" data-elementor-post-type=\"elementor_library\">\n\t\t\t<div class=\"elementor-element elementor-element-182f940 e-con-full e-flex e-con e-parent\" data-id=\"182f940\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-960a9a6 e-con-full e-flex e-con e-child\" data-id=\"960a9a6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a65ff32 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"a65ff32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-phone-alt\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M497.39 361.8l-112-48a24 24 0 0 0-28 6.9l-49.6 60.6A370.66 370.66 0 0 1 130.6 204.11l60.6-49.6a23.94 23.94 0 0 0 6.9-28l-48-112A24.16 24.16 0 0 0 122.6.61l-104 24A24 24 0 0 0 0 48c0 256.5 207.9 464 464 464a24 24 0 0 0 23.4-18.6l24-104a24.29 24.29 0 0 0-14.01-27.6z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf19537 elementor-widget 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\" href=\"https:\/\/productosanitario.es\/en\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Form<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/div>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\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>Medical device evaluation procedures Manufacturers shall carry out an assessment of the conformity of the product prior to placing on the market. In accordance with the following evaluation procedures: Based on a quality management system and the evaluation of technical documentation: The manufacturer will implement, and maintain it throughout the life cycle of the product, [&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-6911","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 evaluation procedures - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"Medical device conformity assessment procedure is the route chosen by the manufacturer to demonstrate compliance\" \/>\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-evaluation-procedures\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical device evaluation procedures - 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