{"id":1034,"date":"2020-06-16T12:57:17","date_gmt":"2020-06-16T12:57:17","guid":{"rendered":"https:\/\/medconcap.com\/eu-authorized-representative"},"modified":"2022-04-28T11:15:39","modified_gmt":"2022-04-28T11:15:39","slug":"eu-authorized-representative","status":"publish","type":"page","link":"https:\/\/medconcap.com\/en\/lasting-service\/eu-authorized-representative","title":{"rendered":"EU Authorized Representative"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\">Why does your company need an EU-Representative?<\/h3>\n\n<p>The international MDR (Medical Devices Regulation) directive requires that any manufacturer of medical devices outside the European Community (EU) must select a company within the EU as its authorized representative.<\/p>\n\n<h3 class=\"wp-block-heading\">What are the tasks of the EU Authorized Representative?<\/h3>\n\n<ul class=\"wp-block-list\"><li>Registration of your devices with national competent authorities, prior to placing on the market.<\/li><li>Main contact for all national competent authorities.<\/li><li>Keeping an up-to-date copy of your Technical Documentation, for inspection by the European Competent Authorities.<\/li><li>Applying our name and address to your product labeling, packaging and instructions for use.<\/li><li>Contact between you and the national competent authorities.<\/li><li>In consultation with you and your distributors, responsible for reporting incidents to the appropriate authorities.<\/li><li>Responsible for protecting the confidentiality of your documentation. The EU-Representative will only submit the Technical Documentation to the Competent Authorities.<\/li><li>Representation to the European Commission to seek advice on the recall of a medical device by one or more Member States. <\/li><li>Retain critical evaluation reports of all data collected during the clinical evaluation for review by the Competent Authorities.<\/li><li>Informing or notification by authorized authorities.<\/li><\/ul>\n<p>Together with our partner <a href=\"https:\/\/sallmann-medical.eu\/\"><strong>Sallmann Medical GmbH<\/strong><\/a> in Austria, we can help you get your product on the market in the EU.<\/p>\n\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\">\n<figure class=\"wp-block-image size-large is-resized\"><a href=\"https:\/\/medconcap.com\/en\/contact\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/medconcap.com\/wp-content\/uploads\/2021\/04\/kontakt-Icon.png\" alt=\"Contact\" class=\"wp-image-749\" width=\"36\" height=\"58\"\/><\/a><\/figure><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<p><strong><a href=\"http:\/\/medconcap.com\/kontakt\">Contact us<\/a> for individual and tailor-made information!<\/strong><\/p>\n<\/div>\n<\/div>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Why does your company need an EU-Representative? The international MDR (Medical Devices Regulation) directive requires that any manufacturer of medical devices outside the European Community (EU) must select a company within the EU as its authorized representative. What are the tasks of the EU Authorized Representative? Registration of your devices with national competent authorities, prior [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1048,"menu_order":-2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-1034","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages\/1034","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/comments?post=1034"}],"version-history":[{"count":1,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages\/1034\/revisions"}],"predecessor-version":[{"id":1035,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages\/1034\/revisions\/1035"}],"up":[{"embeddable":true,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages\/1048"}],"wp:attachment":[{"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/media?parent=1034"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}