{"id":11005,"date":"2024-07-10T08:00:53","date_gmt":"2024-07-10T05:00:53","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11005"},"modified":"2025-08-13T13:45:57","modified_gmt":"2025-08-13T10:45:57","slug":"important-notification-10-07-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-10-07-2024\/","title":{"rendered":"Important notification"},"content":{"rendered":"

10.07.2024<\/strong>
\nTo the attention of all stakeholders<\/strong><\/span>
\nWe inform you that on 9 July 2024, the European Commission published 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 (IVDs).
\nThe regulation provides for the acceleration of the launch and mandatory use of Eudamed for modules which are already available and functioning properly as of the end of 2025 \u2013 thus improving transparency, providing up-to-date information on devices on the EU market and contributing to the monitoring of device availability.
\nLikewise, it introduces an obligation for manufacturers to notify authorities, economic operators and\/or healthcare institutions in advance, in the event of interruptions in the supply of IVDs or medical devices which would pose a risk to patients before temporarily or permanently ceasing the supply of a vital device.
\nThe proposed new transition periods shall depend on the type of device, in particular its risk class, as established in line with Regulation (EU) 2017\/746 (IVDR):
\n\u2013 shorter transition period for high-risk IVDs, class D (31 December 2027)
\n\u2013 longer periods for medium- and low-risk IVDs, classes C and B (31 December 2028 and 31 December 2029 respectively).
\n\u2013 section Directives and regulations \u2013 Medical devices, the Regulation itself (file \u201cREGULATION (EU) 2024_1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL_RO_TXT.pdf\u201d).
\ndownload Regulation …<\/a>
\ndownload the Questions & Answers Guide on practical aspects related to the implementation of Regulation (EU) 2024_1860 …<\/a>
\ndownload the Questions and Answers Guide on practical aspects related to the implementation of Regulation (EU) 2024_745_rev.2 …<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

10.07.2024 To the attention of all stakeholders We inform you that on 9 July 2024, the European Commission published Regulation […]<\/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-11005","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\/11005","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=11005"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11005\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11005"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11005"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11005"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}