{"id":6915,"date":"2021-11-05T08:49:47","date_gmt":"2021-11-05T07:49:47","guid":{"rendered":"https:\/\/productosanitario.es\/authorized-medical-device-representative\/"},"modified":"2025-03-06T15:45:01","modified_gmt":"2025-03-06T14:45:01","slug":"authorized-medical-device-representative","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/authorized-medical-device-representative\/","title":{"rendered":"Authorized Medical Device Representative"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6915\" class=\"elementor elementor-6915 elementor-4476\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f543715 e-flex e-con-boxed e-con e-parent\" data-id=\"f543715\" 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-8454a50 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"8454a50\" 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\">Authorized representative of <b>medical device<\/b> manufacturers<\/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-f6c33dd e-flex e-con-boxed e-con e-parent\" data-id=\"f6c33dd\" 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-ad803b8 elementor-widget__width-inherit elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"ad803b8\" 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\">The authorised representative of medical device manufacturers shall be any natural or legal person established in the Union; that you have received and accepted a written mandate from a manufacturer. That manufacturer shall be located outside the European Union to act on its behalf in relation to specific tasks as regards its obligations under the MDR Regulation.<\/p>\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-53f5786 e-con-full e-flex e-con e-parent\" data-id=\"53f5786\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-212ac37 e-con-full e-flex e-con e-child\" data-id=\"212ac37\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5002c24 elementor-widget elementor-widget-text-editor\" data-id=\"5002c24\" 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><strong>PS Consulting<\/strong>, as an authorised representative of medical device manufacturers, shall ensure that devices placed on the Union market comply with the following regulatory requirements:<\/p><ul><li>Verify that the <a href=\"https:\/\/productosanitario.es\/en\/declaration-of-conformity\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">EU declaration of conformity<\/a> and the technical documentation of the product have been prepared.<\/li><li>To keep a copy of the technical documentation available to the competent authorities; the EU declaration of conformity and, where appropriate, a copy of the corresponding certificate.<\/li><li>Comply with the obligations of registration with <a href=\"http:\/\/www.eudamed.es\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">EUDAMED <\/a>and verify that the manufacturer has also complied with it.<\/li><li>Provide all the information and documentation necessary to demonstrate the conformity of the product to the competent authorities, upon request.<\/li><li>Transmit to the manufacturer any request for samples or access to a product by a competent authority.<\/li><li>Cooperate with the competent authorities in any preventive or corrective action that is adopted.<\/li><li>Immediately notify the manufacturer of complaints and reports from health professionals related to the product.<\/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-7b37861 e-con-full e-flex e-con e-child\" data-id=\"7b37861\" 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-575c23f e-flex e-con-boxed e-con e-parent\" data-id=\"575c23f\" 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-c3c7949 e-con-full e-flex e-con e-child\" data-id=\"c3c7949\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-14be388 elementor-widget elementor-widget-heading\" data-id=\"14be388\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Needs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf664ed elementor-widget elementor-widget-text-editor\" data-id=\"bf664ed\" 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 designation as an authorized representative will be established by a contract signed by the manufacturer of the medical device and PS Consulting. This contract will establish the obligations of both parties.<\/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-09a5282 e-flex e-con-boxed e-con e-parent\" data-id=\"09a5282\" 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-568be90 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"568be90\" 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\">At <b>PS Consulting<\/b> we will be happy to help introduce safe and effective medical devices to the EU market.<\/p>\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-b66a7f8 e-flex e-con-boxed e-con e-parent\" data-id=\"b66a7f8\" 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-a6f100d elementor-widget elementor-widget-heading\" data-id=\"a6f100d\" 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-26f1cc6 elementor-grid-tablet-3 elementor-widget__width-inherit elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"26f1cc6\" 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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Authorized representative of medical device manufacturers The authorised representative of medical device manufacturers shall be any natural or legal person established in the Union; that you have received and accepted a written mandate from a manufacturer. That manufacturer shall be located outside the European Union to act on its behalf in relation to specific tasks [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6915","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>Authorized Medical Device Representative - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"Authorised representative of medical device manufacturers, is any person established in the Union acting on their behalf\" \/>\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\/authorized-medical-device-representative\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Authorized Medical Device Representative - 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