{"id":9327,"date":"2022-06-12T12:19:18","date_gmt":"2022-06-12T10:19:18","guid":{"rendered":"http:\/\/www.thema-med.com\/unique-device-identification-udi-tracciabilita-software-medico\/"},"modified":"2022-06-12T12:19:18","modified_gmt":"2022-06-12T10:19:18","slug":"unique-device-identification-udi-and-traceability-for-medical-software","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/06\/12\/unique-device-identification-udi-and-traceability-for-medical-software\/","title":{"rendered":"EXPORTING MEDICAL DEVICES IN EUROPE? YOU NEED AN EUROPEAN AUTHORISED REPRESENTATIVE"},"content":{"rendered":"\n<p>This  White Paper focuses on the figure of the European Authorised Representative (EU  REP), who plays a fundamental role in the CE marking process of Medical  Devices. In fact, if you are a Manufacturer based outside the EU, you must  appoint an EU REP to export your Medical Devices to Europe. By reading this White  Paper you will have useful information on the role of the European Authorised  Representative, its responsibilities and how to select it.<\/p>\n\n\n\n<ul class=\"wp-block-gallery columns-1 is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\"><li class=\"blocks-gallery-item\"><figure><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/06\/desk-1-1024x683.jpg\" alt=\"\" data-id=\"20982\" data-link=\"https:\/\/www.thema-med.com\/?attachment_id=20982\" class=\"wp-image-20982\"\/><\/figure><\/li><\/ul>\n\n\n\n<p style=\"color:#0099a8\" class=\"has-text-color\"><strong>Fill out the <em>form<\/em> and get your Whitepaper free of charge!<\/strong><\/p>\n\n\n\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f20993-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"20993\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/posts\/9327#wpcf7-f20993-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"20993\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.1\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f20993-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_group_fields\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_visible_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_repeaters\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_steps\" value=\"{}\" \/><input type=\"hidden\" name=\"_wpcf7cf_options\" value=\"{&quot;form_id&quot;:20993,&quot;conditions&quot;:[],&quot;settings&quot;:{&quot;animation&quot;:&quot;yes&quot;,&quot;animation_intime&quot;:200,&quot;animation_outtime&quot;:200,&quot;conditions_ui&quot;:&quot;normal&quot;,&quot;notice_dismissed&quot;:false,&quot;notice_dismissed_update-cf7-6.1.1&quot;:true}}\" \/><input type=\"hidden\" name=\"_wpcf7dtx_version\" value=\"5.0.3\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<h2><strong>Are you a Manufacturer exporting Medical Devices in Europe?<\/strong>\n<\/h2>\n<p><strong>Fill out the form!<\/strong>\n<\/p>\n<p>You will receive our White Paper directly in your inbox: a <strong>valuable help<\/strong> to understand the necessary actions to be taken to <strong>Export your medical devices in Europe<\/strong>.\n<\/p>\n<table>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Name\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"nome\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"nome\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Surname\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"cognome\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"cognome\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Company\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"azienda\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"azienda\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<td>\n\t\t<p>Role\n\t\t<\/p>\n\t<\/td>\n\t<td>\n\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"ruolo\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"ruolo\"><option value=\"\">&#8212;Please choose an option&#8212;<\/option><option value=\"Purchasing\">Purchasing<\/option><option value=\"Sales\">Sales<\/option><option value=\"Marketing\">Marketing<\/option><option value=\"Administration\">Administration<\/option><option value=\"QA\/RA\">QA\/RA<\/option><option value=\"Management\">Management<\/option><option value=\"R &amp; D\">R &amp; D<\/option><option value=\"Other\">Other<\/option><\/select><\/span>\n\t\t<\/p>\n\t<\/td>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Email\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td colspan=\"2\">\n\t\t\t<table>\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"acceptance-729\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"acceptance-729\" value=\"1\" aria-invalid=\"false\" \/><\/span><\/span><\/span>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t<\/td>\n\t\t\t\t\t<td style=\"font-size:11px; padding-left:12px;\">\n\t\t\t\t\t\t<p>Consent to processing of data<br \/>\nin accordance with D. Lgs. 196\/2003 adapted to the GDPR 679\/16 EU by the D. Lgs. 101\/2018, I agree to receive the CONTENT referred to in question and receive the periodic NEWSLETTER INFORMATION Thema S.r.l<br \/>\n<a href=\"https:\/\/www.thema-med.com\/en\/newsletter-information\/ \">Information concerning the processing of personal data<\/a>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t<\/td>\n\t\t\t\t<\/tr>\n\t\t\t<\/table>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>&nbsp;\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Download the Whitepaper\" \/>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n<\/table><div class=\"fusion-alert alert custom alert-custom fusion-alert-center wpcf7-response-output fusion-alert-capitalize awb-alert-native-link-color\" style=\"--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"fusion-alert-content\"><\/span><\/div><\/div>\n<\/form>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>This White Paper focuses on the figure of the European Authorised Representative (EU REP), who plays a fundamental role in the  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[16],"tags":[],"class_list":["post-9327","post","type-post","status-publish","format-standard","hentry","category-libreria"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EXPORTING MEDICAL DEVICES IN EUROPE? 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