{"id":11036,"date":"2023-10-06T08:00:04","date_gmt":"2023-10-06T05:00:04","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11036"},"modified":"2025-08-14T08:43:10","modified_gmt":"2025-08-14T05:43:10","slug":"important-notification-06-10-2023","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-06-10-2023\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>06.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all interested parties<\/strong><\/span><br \/>\nPlease be informed that on 27 September 2023, the European Commission published the new version of the document Manual on borderline and classification for medical devices under Regulation (EU) 2017\/745 on medical devices and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices.<br \/>\nNew products such as endovascular adhesives, sensors, irrigation solutions, customised implants and many more have been introduced.<br \/>\nThe European Commission notification is available at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/manual-borderline-and-classification-community-regulatory-framework-medical-devices-september-2023-2023-09-27_en\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/manual-borderline-and-classification-community-regulatory-framework-medical-devices-september-2023-2023-09-27_en<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/md_borderline_manual_en.pdf\" rel=\"noopener\" target=\"_blank\">document download &#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>06.10.2023 To the attention of manufacturers, authorised representatives, economic operators and all interested parties Please be informed that on 27 [&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-11036","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\/11036","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=11036"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11036\/revisions"}],"predecessor-version":[{"id":11038,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11036\/revisions\/11038"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11036"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11036"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11036"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}