{"id":6879,"date":"2019-02-27T18:16:14","date_gmt":"2019-02-27T17:16:14","guid":{"rendered":"https:\/\/productosanitario.es\/declaration-of-conformity\/"},"modified":"2025-03-07T17:36:08","modified_gmt":"2025-03-07T16:36:08","slug":"declaration-of-conformity","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/declaration-of-conformity\/","title":{"rendered":"Declaration of conformity"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6879\" class=\"elementor elementor-6879 elementor-2804\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5633582 e-con-full e-flex e-con e-parent\" data-id=\"5633582\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-634fabc e-con-full e-flex e-con e-child\" data-id=\"634fabc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ba308d1 elementor-widget elementor-widget-heading\" data-id=\"ba308d1\" 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\">Declaration of conformity<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e8f5666 elementor-widget elementor-widget-text-editor\" data-id=\"e8f5666\" 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:\/\/productosanitario.es\/category\/documentacion-entregada-por-el-fabricante\/declaracion-de-conformidad-de-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">EU declaration of conformity<\/a> shall find that the <a href=\"https:\/\/productosanitario.es\/en\/medical-device-requirements\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">specified requirements <\/a>for the <a href=\"https:\/\/www.productosanitario.es\/producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">product<\/a> have been met. The manufacturer shall keep this declaration continuously updated, translating it into the official language(s) of the State in which the product is marketed. <\/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-b1eaafc e-con-full e-flex e-con e-child\" data-id=\"b1eaafc\" 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-50a2bbf e-flex e-con-boxed e-con e-parent\" data-id=\"50a2bbf\" 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-f3e2fb7 e-con-full e-flex e-con e-child\" data-id=\"f3e2fb7\" 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-80696c4 e-con-full e-flex e-con e-child\" data-id=\"80696c4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f07c9f0 elementor-widget elementor-widget-text-editor\" data-id=\"f07c9f0\" 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>It shall contain at least the following <a href=\"https:\/\/productosanitario.es\/category\/documentacion-entregada-por-el-fabricante\/\" target=\"_blank\" rel=\"noopener\">information<\/a>:<\/p><ul><li>Trade name or registered trademark of the manufacturer and its address or registered office for contact purposes.<\/li><li>Affirmation that the statement is issued under your sole responsibility.<\/li><li>The Basic <a href=\"https:\/\/productosanitario.es\/caracterizacion-del-udi-de-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">UDI-DI<\/a> .<\/li><li>Name and trade name of the product, code or other unequivocal reference that allows the <a href=\"https:\/\/productosanitario.es\/identificacion-y-trazabilidad-de-los-productos-sanitarios\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">identification and traceability<\/a> of the product, as well as its <a href=\"https:\/\/www.productosanitario.es\/finalidad-prevista\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">intended purpose<\/a>.<\/li><li><a href=\"https:\/\/productosanitario.es\/eudamed-european-database-on-medical-devices\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Risk class of<\/a> the product.<\/li><li>Affirmation that the product is in compliance with the applicable legislation.<\/li><li>References to the common specifications used.<\/li><li>Name and identification number of the Notified Body (ON), description <a href=\"https:\/\/productosanitario.es\/en\/medical-device-evaluation-procedures\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">of the conformity assessment<\/a> procedure and identification of the certificate issued by the ON.<\/li><li>Supplementary information, if applicable.<\/li><li>Place and date of issuance of the declaration, name and position of the person who signed it, together with his or her own signature.<\/li><\/ul><p>The <a href=\"https:\/\/productosanitario.es\/category\/documentacion-entregada-por-el-fabricante\/declaracion-de-conformidad-de-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">declaration of conformity<\/a> is part of the documents that must be delivered to the user by the manufacturer, and it is the responsibility of the <a href=\"https:\/\/productosanitario.es\/en\/medical-device-technical-manager\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Technical Manager<\/a> to ensure that this is the case.<\/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-f1cb49e e-flex e-con-boxed e-con e-parent\" data-id=\"f1cb49e\" 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-c79c606 elementor-widget elementor-widget-heading\" data-id=\"c79c606\" 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-f051b78 elementor-grid-tablet-3 elementor-widget__width-inherit elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"f051b78\" 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-b2da0b6 e-flex e-con-boxed e-con e-parent\" data-id=\"b2da0b6\" 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-e34f7da elementor-widget elementor-widget-shortcode\" data-id=\"e34f7da\" 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>Declaration of conformity The EU declaration of conformity shall find that the specified requirements for the product have been met. The manufacturer shall keep this declaration continuously updated, translating it into the official language(s) of the State in which the product is marketed. It shall contain at least the following information: Trade name or registered [&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-6879","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>Declaration of conformity - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"The declaration of conformity is the document used by the manufacturer to declare, under his responsibility, the conformity 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\/declaration-of-conformity\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Declaration of conformity - 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