{"id":9619,"date":"2022-09-19T08:00:37","date_gmt":"2022-09-19T05:00:37","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=9619"},"modified":"2022-11-09T11:19:47","modified_gmt":"2022-11-09T08:19:47","slug":"important-notification-19-09-2022","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-19-09-2022\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>19.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders<\/strong><\/span><br \/>\nPlease be informed that, on 14 September 2022, the European Commission published the MDCG 2021-22 Rev.1 \u2013 Clarification on \u201cfirst certification for that type of device\u201d and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert group referred to in Article 48(6) of Regulation (EU) 2017\/746.<br \/>\nThis document provides information on Class D devices, Article 48(6) of Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR) \u2013 sets out the conditions to be applied by the notified body in order to determine whether the expert group must be consulted on the manufacturer&#8217;s performance assessment report.<br \/>\nThese conditions are: (1) the absence of common specifications for the Class D device in question;<br \/>\n(2) where is the first certification for that specific type of device.<br \/>\nThis guideline provides clarification on the meaning of these conditions and the corresponding procedures to be followed by the notified body.<br \/>\nThe notification of the European Commission is available online: <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2021-22_en.pdf\" rel=\"noopener\" target=\"_blank\">https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2021-22_en.pdf<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>19.09.2022 To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders Please [&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-9619","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\/9619","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=9619"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9619\/revisions"}],"predecessor-version":[{"id":9620,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9619\/revisions\/9620"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9619"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=9619"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=9619"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}