{"id":10992,"date":"2024-11-01T08:00:05","date_gmt":"2024-11-01T05:00:05","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=10992"},"modified":"2025-08-13T12:01:59","modified_gmt":"2025-08-13T09:01:59","slug":"important-notification-01-11-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-01-11-2024\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>01.11.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers and all interested stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 30.10.2024, the European Commission published the Questions and Answers Guideline (Q&#038;A) on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024\/1860 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices, as introduced by Regulation (EU) 2024\/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.<br \/>\nThe document is available here:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf\" target=\"_blank\">https:\/\/health.ec.europa.eu\/document\/download\/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdr_qna-article10a_mdr-ivdr_en.pdf\" rel=\"noopener\" target=\"_blank\">download document &#8230;<\/a><img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>01.11.2024 To the attention of manufacturers and all interested stakeholders Please be informed that on 30.10.2024, the European Commission published [&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-10992","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\/10992","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=10992"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10992\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10992"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10992"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10992"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}