{"id":9941,"date":"2023-05-19T08:00:18","date_gmt":"2023-05-19T05:00:18","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=9941"},"modified":"2023-07-04T13:28:16","modified_gmt":"2023-07-04T10:28:16","slug":"important-notification-19-05-2023","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-19-05-2023\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>19.05.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be advised that on 12 May 2023, the European Commission published the revision of document MDCG 2020-3 with guidance on the significant changes to the transitional provision in Article 120 of the MDR relating to devices covered by certificates, in line with the MDD or the AIMDD.<br \/>\nThe changes made are as follows:<br \/>\nSection 4.1 \u2013 General provisions:<br \/>\n\u2022 Minor text change to clarify the fact that the changes made in order to comply with other Union legislation fall within the scope of the guidance only if the risk\/benefit balance of the device is not adversely affected.<br \/>\n\u2022 Minor text change and introduction of a footnote regarding the validity of certificates during the transition period.<br \/>\n\u2022 Introduction of a footnote regarding statements listing insignificant changes for Class I devices.<br \/>\nSection 4.2 \u2013 Changes unrelated to design or intended purpose:<br \/>\n\u2022 Introduction of a footnote to rule out changing the legal manufacturer in the first example provided.<br \/>\n\u2022 Introduction of a final statement regarding the notification procedure agreed between the manufacturer and the notified body.<br \/>\nIn section 4.3.2.3 \u2013 Design changes:<br \/>\n\u2022 Improved text in examples related to changes brought to device case and user interface layout, for more clarity.<br \/>\n\u2022 Inclusion of a note on the Benefit\/Risk balance (in bold) in each subsection, for better reading and understanding.<br \/>\nThe European Commission notification can be accessed at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en <\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdcg_2020-3_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>19.05.2023 To the attention of manufacturers, authorised representatives, economic operators and all stakeholders Please be advised that on 12 May [&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-9941","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\/9941","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=9941"}],"version-history":[{"count":2,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9941\/revisions"}],"predecessor-version":[{"id":9943,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9941\/revisions\/9943"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9941"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=9941"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=9941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}