{"id":11398,"date":"2025-11-28T08:00:59","date_gmt":"2025-11-28T05:00:59","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11398"},"modified":"2025-12-02T12:44:12","modified_gmt":"2025-12-02T09:44:12","slug":"important-notification-28-11-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-28-11-2025\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>28.11.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested parties<\/strong><\/span><br \/>\nThe European Commission published in the Official Journal of the European Union Commission Decision (EU) 2025\/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices (EUDAMED):<br \/>\n<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/PDF\/?uri=OJ:L_202502371\" target=\"_blank\">https:\/\/eur-lex.europa.eu\/legal-content\/RO\/TXT\/PDF\/?uri=OJ:L_202502371<\/a><br \/>\nThis confirms that the following electronic systems included in the EUDAMED are functional and meet the functional specifications mentioned in Article 34(2) of Regulation (EU) 2017\/745:<br \/>\n\u2022 the electronic system for the registration of economic operators (<strong>Actor registration<\/strong>) \u2013 referred to in Article 30 of Regulation (EU) 2017\/745(MDR) and in Article 27 of Regulation (EU) 2017\/746(IVDR);<br \/>\n\u2022 the UDI database and the electronic system for device registration (<strong>UDI\/Device registration<\/strong>) \u2013 referred to in Articles 28 and 29 of Regulation (EU) 2017\/745(MDR) and in Articles 25 and 26 of Regulation (EU) 2017\/746(IVDR);<br \/>\n\u2022 the electronic system for notified bodies and certificates (<strong>Notified Bodies and Certificates module<\/strong>) \u2013 referred to in Article 57 of Regulation (EU) 2017\/745(MDR) and in Article 52 of Regulation (EU) 2017\/746(IVDR);<br \/>\n\u2022 the electronic market surveillance system (<strong>Market Surveillance<\/strong>) \u2013 referred to in Article 100 of Regulation (EU) 2017\/745(MDR) and in Article 95 of Regulation (EU) 2017\/746(IVDR).<br \/>\nThe obligations and requirements related to the Eudamed apply from the date corresponding to a 6-month period from the date of the aforementioned publication (according to Article 123 of the MDR, Article 113 of the IVDR), namely from <strong>28 May 2026<\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>28.11.2025 To the attention of all interested parties The European Commission published in the Official Journal of 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-11398","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\/11398","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=11398"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11398\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11398"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11398"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11398"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}