{"id":24,"date":"2016-02-12T08:13:06","date_gmt":"2016-02-12T08:13:06","guid":{"rendered":"http:\/\/demos.famethemes.com\/onepress\/?page_id=24"},"modified":"2025-12-19T18:13:08","modified_gmt":"2025-12-19T18:13:08","slug":"european-authorized-representative-ec-rep","status":"publish","type":"page","link":"https:\/\/angell-tech.com\/en\/services\/european-authorized-representative-ec-rep\/","title":{"rendered":"European Authorized Representative (EC REP)"},"content":{"rendered":"<h2>Your Partner for EU Market Entry<\/h2>\n<p>For medical device manufacturers located outside the European Union, appointing a European Authorized Representative is a legal requirement. Angell Technology GmbH acts as your competent <b data-path-to-node=\"10\" data-index-in-node=\"249\">EC REP,<\/b>ensuring that your products meet all requirements of the MDR (EU) 2017\/745. We help you navigate the complex regulatory landscape safely and successfully expand your market presence in Europe.<\/p>\n<h2 data-path-to-node=\"12\">Our Services as Your EU Authorized Representative<\/h2>\n<p data-path-to-node=\"13\">We take full responsibility for your regulatory compliance and serve as the official interface to the European market supervisory authorities.<\/p>\n<h3 data-path-to-node=\"15\">EUDAMED Management &amp; Registration<\/h3>\n<p data-path-to-node=\"16\">We carry out the necessary registrations in the European database for medical devices<b data-path-to-node=\"16\" data-index-in-node=\"94\">(EUDAMED)<\/b>.<\/p>\n<ul data-path-to-node=\"17\">\n<li>\n<p data-path-to-node=\"17,0,0\">Actor registration (SRN application).<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,1,0\">Support for UDI assignment and product registration.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,2,0\">Continuous data maintenance in accordance with legal deadlines.<\/p>\n<\/li>\n<\/ul>\n<h3 data-path-to-node=\"19\">Document Review &amp; Compliance Check<\/h3>\n<p data-path-to-node=\"20\">Before your products reach the European market, we subject your technical documentation to a rigorous review.<\/p>\n<ul data-path-to-node=\"21\">\n<li>\n<p data-path-to-node=\"21,0,0\">Verification of the Declaration of Conformity and technical files.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"21,1,0\">Review of labeling and instructions for use (IFU).<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"21,2,0\">Management and provision of documentation for national authorities.<\/p>\n<\/li>\n<\/ul>\n<h2 data-path-to-node=\"23\">Legally Secure Contracts &amp; Monitoring<\/h2>\n<p data-path-to-node=\"24\">As your EAR, we ensure that all contractual foundations meet current requirements. We support you with Post-Market Surveillance (PMS) and the reporting of serious incidents (Vigilance), ensuring your EU business stands on a secure long-term foundation.<\/p>\n<p data-path-to-node=\"24\"><b data-path-to-node=\"25\" data-index-in-node=\"32\">Do you want to distribute your medical devices in the EU?<\/b> Contact us for a non-binding consultation regarding our EAR services.<\/p>\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Your regulatory partner in the EU. We support non-EU manufacturers with EUDAMED entries, document reviews, and MDR compliance.<\/p>","protected":false},"author":2,"featured_media":0,"parent":2731,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"template-fullwidth.php","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"European Authorized Representative (EC REP) f\u00fcr Medizinprodukte: Wir \u00fcbernehmen EUDAMED-Registrierungen, Dokumentenpr\u00fcfung & EU-Compliance f\u00fcr Nicht-EU-Hersteller.","_seopress_robots_index":"","footnotes":""},"class_list":["post-24","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/pages\/24","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/comments?post=24"}],"version-history":[{"count":11,"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/pages\/24\/revisions"}],"predecessor-version":[{"id":3219,"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/pages\/24\/revisions\/3219"}],"up":[{"embeddable":true,"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/pages\/2731"}],"wp:attachment":[{"href":"https:\/\/angell-tech.com\/en\/wp-json\/wp\/v2\/media?parent=24"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}