{"id":9790,"date":"2023-02-28T08:00:30","date_gmt":"2023-02-28T05:00:30","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=9790"},"modified":"2023-03-14T11:55:57","modified_gmt":"2023-03-14T08:55:57","slug":"important-notification-28-02-2023","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-28-02-2023\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>28.02.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all economic operators<\/strong><\/span><br \/>\nPlease note that only manufacturers of medical devices <strong>outside the European Union<\/strong> are required to appoint a single <strong>authorised representative<\/strong> to introduce the device on the EU market.<br \/>\nIn line with Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, &#8220;<strong>authorised representative<\/strong>&#8221; means any physical or legal person established in the EU who has received and accepted a written mandate from a manufacturer outside the Union, to act on behalf of the manufacturer in relation to specified tasks regarding the latter&#8217;s obligations arising from this Regulation.<br \/>\n<strong>Only authorised representatives residing in Romania are required to register into the NAMMDR national database, when introducing the following types of medical devices on the market:<br \/>\na) class I, IIa, IIb and III medical devices, including sterile and\/or measuring devices;<br \/>\nb) systems and procedure sets covered by Article 22 of the Regulation;<br \/>\nc) active implantable medical devices.<br \/>\nAuthorized representatives residing in other member states of the European Union shall NOT BE REGISTERED into the national database.<\/strong><br \/>\nMoreover, free sale certificates are issued for export purposes only to authorised representatives residing in Romania.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>28.02.2023 To the attention of all economic operators Please note that only manufacturers of medical devices outside the European Union [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-9790","post","type-post","status-publish","format-standard","hentry","category-anunturi-importante-dispozitive-medicale"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9790","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=9790"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9790\/revisions"}],"predecessor-version":[{"id":9791,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9790\/revisions\/9791"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9790"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=9790"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=9790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}