{"id":9773,"date":"2022-12-06T09:00:17","date_gmt":"2022-12-06T06:00:17","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=9773"},"modified":"2023-03-14T09:41:33","modified_gmt":"2023-03-14T06:41:33","slug":"important-notification-06-12-2022-2","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-06-12-2022-2\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>06.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers, authorised representatives, economic operators and all stakeholders<\/strong><\/span><br \/>\nWe hereby inform you that on 1 December 2022, Commission Implementing Regulation (EU) 2022\/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices was published in the Official Journal.<br \/>\nRegulation (EU) 2017\/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. Regulation (EU) 2017\/745 further requires the Commission to adopt for groups of products without an intended medical purpose listed in its Annex XVI, common specifications addressing, at least, application of risk management as set out in the general safety and performance requirements laid down in Annex I to that Regulation and, where necessary, clinical evaluation regarding safety.<br \/>\nClassification rules 9 and 10 on active devices in sections 6.1. and 6.2. of Annex VIII to Regulation (EU) 2017\/745 refers to an intended medical purpose, namely for therapy and diagnosis, and therefore cannot be applied to active products without an intended medical purpose, referred to in Article 1 paragraph (2) of this Regulation. Therefore, such products must be classified in class I in accordance with rule 13 of section 6.5. of Annex VIII to Regulation (EU) 2017\/745.<br \/>\nThe announcement of the European Commission is available online at: <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2022\/2346\/oj\" rel=\"noopener\" target=\"_blank\">EUR-Lex \u2013 32022R2346 \u2013 EN \u2013 EUR-Lex (europa.eu)<\/a> \u0219i <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2022\/2347\/oj\" rel=\"noopener\" target=\"_blank\">EUR-Lex \u2013 32022R2347 \u2013 EN \u2013 EUR-Lex (europa.eu)<\/a>.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/CELEX_32022R2346_RO_TXT.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\" \/><br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/DM\/CELEX_32022R2347_RO_TXT.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>06.12.2022 To the attention of manufacturers, authorised representatives, economic operators and all stakeholders We hereby inform you that on 1 [&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-9773","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\/9773","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=9773"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9773\/revisions"}],"predecessor-version":[{"id":9774,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9773\/revisions\/9774"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9773"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=9773"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=9773"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}