{"id":9704,"date":"2021-07-20T08:00:25","date_gmt":"2021-07-20T05:00:25","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=9704"},"modified":"2023-01-09T16:31:56","modified_gmt":"2023-01-09T13:31:56","slug":"important-notification-20-07-2021","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-20-07-2021\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>20.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of Romanian manufacturers of medical devices\/authorised representatives<\/strong><\/span><br \/>\n<strong>Registration of &#8220;Legacy devices&#8221; into the EUDAMED<\/strong><br \/>\n&#8220;Legacy devices&#8221; are defined as medical devices, active implantable medical devices and in vitro diagnostic medical devices <strong>covered by a valid EC certificate of compliance issued in accordance with Directive 93\/42\/EEC, Directive 90\/385\/EEC or Directive 98\/79\/EC and which continue to be placed on the market after the date of application of Regulation (EU) 2017\/745 (MDR) or Regulation 2017\/746 (IVDR)<\/strong>.<br \/>\n&#8220;Legacy devices&#8221; are subject to MDR or IVDR registration requirements, with some exceptions, such as the assignment of a base UDI-DI and a UDI-DI.<br \/>\nManufacturers will have the possibility to register any of the &#8220;legacy devices&#8221; in EUDAMED. Indications regarding the registration of &#8220;Legacy devices&#8221; in EUDAMED are provided in the document &#8220;MDCG 2019-5 Registration of legacy devices in EUDAMED April 2019&#8221; (<a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/34922\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/docsroom\/documents\/34922<\/a>).<br \/>\nAlthough the assignment of a basic UDI-DI and UDI-DI is not necessary for a &#8220;legacy device&#8221;, in order to keep the same standard structure and identifiers for all devices registered into the EUDAMED, an EUDAMED DI identifier (the equivalent of the UDI- Basic DI) will be required and a EUDAMED ID (if no UDI-DI has been assigned) will be generated from the EUDAMED DI.<br \/>\nThe basic UDI-DI will never be applicable and assigned to a &#8220;legacy device&#8221;, only the EUDAMED DI will.<br \/>\nThe UDI-DI can be used to identify a legacy device into the EUDAMED, however, only one device identifier will be assigned to a &#8220;legacy device&#8221;, as follows:<br \/>\n\u2022 either a UDI-DI (where EUDAMED DI is automatically generated),<br \/>\n\u2022 either a EUDAMED DI (where the EUDAMED ID is automatically generated).<br \/>\nFor more information, please read the document &#8220;Management of Legacy Devices &#8211; MDR EUDAMED&#8221;: <a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/legacy_dvc_management_en.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/legacy_dvc_management_en.pdf<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>20.07.2021 To the attention of Romanian manufacturers of medical devices\/authorised representatives Registration of &#8220;Legacy devices&#8221; into the EUDAMED &#8220;Legacy devices&#8221; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9,20],"tags":[],"class_list":["post-9704","post","type-post","status-publish","format-standard","hentry","category-anunturi-importante-dispozitive-medicale","category-noutati-implementare-mdr-ivdr"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9704","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=9704"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9704\/revisions"}],"predecessor-version":[{"id":9707,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9704\/revisions\/9707"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9704"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=9704"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=9704"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}