{"id":11116,"date":"2025-07-31T08:00:12","date_gmt":"2025-07-31T05:00:12","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11116"},"modified":"2025-08-19T07:20:02","modified_gmt":"2025-08-19T04:20:02","slug":"important-notification-31-07-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-31-07-2025\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>31.07.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices and in vitro diagnostic medical devices and all interested parties<\/strong><\/span><br \/>\nIn line with the COMMISSION IMPLEMENTING DECISION (EU) 2019\/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices, renewed for a five-year period, from 27 June 27 2024 to 27 June 2029 in line with the Commission Implementing Decision (EU) 2024\/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices, the following organizations were officially recognized by the European Commission as UDI-issuing entities:<br \/>\n\u2013 GS1 AISBL,<br \/>\n\u2013 Health Industry Business Communications Council (HIBCC)<br \/>\n\u2013 ICCBBA<br \/>\n\u2013 Informationsstelle f\u00fcr Arzneispezialit\u00e4ten \u2014 IFA GmbH<br \/>\nThese decisions have been published in the Official Journal of the European Union.<br \/>\nThus, we inform you that only these 4 entities are designated by the Commission and can issue the UDI.<br \/>\nIf you have contracted another organization apart from the 4 listed above for issuing the unique device identifier of a device (&#8220;UDI system&#8221;) or if you are aware of such organizations which claim to be issuing UDI, you need to notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Regulatory Directorate, Market Supervision (<a href=\"mailto:dgdm@anm.ro\">dgdm@anm.ro<\/a> and <a href=\"mailto:drsp@anm.ro\">drsp@anm.ro<\/a>), using the contact data available on the NAMMDR website.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>31.07.2025 To the attention of Romanian manufacturers of medical devices and in vitro diagnostic medical devices and all interested parties [&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-11116","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\/11116","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=11116"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11116\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11116"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11116"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11116"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}