{"id":9708,"date":"2021-11-15T08:00:25","date_gmt":"2021-11-15T05:00:25","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=9708"},"modified":"2023-01-09T16:34:14","modified_gmt":"2023-01-09T13:34:14","slug":"important-notification-15-11-2021","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-15-11-2021\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>15.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices<\/strong><\/span><br \/>\n<strong>UDI\/Device registration \u2013 in EUDAMED<\/strong><br \/>\nThe new EU regulations of <strong>MDR 2017\/745 and IVDR 2017\/746<\/strong> introduce a medical device identification system based on a unique device identifier (UDI), which allows easier traceability. These regulations require medical device manufacturers to submit UDI\/Device information for all medical devices they place on the market. The UDI-DI\/Device module of EUDAMED is used for this purpose.<br \/>\nFrom October 2021, EUDAMED&#8217;s UDI-DI\/Device module is available and manufacturers can already enter the UDI\/Device information into the system voluntarily.<br \/>\nFor more information, we recommend that you access the European Commission website: <a href=\"https:\/\/ec.europa.eu\/health\/md_eudamed\/udi_devices_registration_ro\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/health\/md_eudamed\/udi_devices_registration_ro<\/a><br \/>\nThe guideline providing all the information required in order to register UDI\/Devices into the Eudamed can be accessed here: <a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/md_eudamed_udi-devices-user-guide_en .pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/md_eudamed_udi-devices-user-guide_en.pdf<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>15.11.2021 To the attention of Romanian manufacturers of medical devices UDI\/Device registration \u2013 in EUDAMED The new EU regulations of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9,20],"tags":[],"class_list":["post-9708","post","type-post","status-publish","format-standard","hentry","category-anunturi-importante-dispozitive-medicale","category-noutati-implementare-mdr-ivdr"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9708","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=9708"}],"version-history":[{"count":2,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9708\/revisions"}],"predecessor-version":[{"id":9710,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9708\/revisions\/9710"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9708"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=9708"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=9708"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}