{"id":9763,"date":"2022-11-07T08:00:43","date_gmt":"2022-11-07T05:00:43","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=9763"},"modified":"2023-03-14T09:28:29","modified_gmt":"2023-03-14T06:28:29","slug":"important-notification-07-11-2022","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-07-11-2022\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>07.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of authorised representatives, manufacturers, economic operators and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that on 31 October 2022, the European Commission published the MDCG 2022-16 Guidance: Guidance on Authorised Representatives Regulation (EU) 2017\/745 on medical devices (MDR) and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR)<br \/>\nThis guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the two Regulations.<br \/>\nWhere clarification is already covered by other MDCG guidances, this guidance on authorised representatives includes a reference.<br \/>\nThe requirement to have an authorised representative is not applicable to devices intended for clinical investigation (MDR) or performance study (IVDR).<br \/>\nTo this end, Article 62(2) MDR and Article 58(4) IVDR state that \u2018where the sponsor of a clinical investigation or performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative\u2019<br \/>\nAs the legal representative is not defined as the authorised representative, these requirements are not further included in this guidance.<br \/>\nThe announcement of the European Commission is available online at: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-16-guidance-authorised-representatives-regulation-eu-2017745-and-regulation-eu-2017746-2022-10-31_en\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-16-guidance-authorised-representatives-regulation-eu-2017745-and-regulation-eu-2017746-2022-10-31_en<\/a><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/mdcg_202216_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>07.11.2022 To the attention of authorised representatives, manufacturers, economic operators and all stakeholders Please be informed that on 31 October [&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-9763","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\/9763","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=9763"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9763\/revisions"}],"predecessor-version":[{"id":9766,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9763\/revisions\/9766"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9763"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=9763"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=9763"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}