{"id":7534,"date":"2022-12-12T14:17:58","date_gmt":"2022-12-12T13:17:58","guid":{"rendered":"https:\/\/www.unmz.gov.cz\/?p=7534"},"modified":"2022-12-12T14:19:24","modified_gmt":"2022-12-12T13:19:24","slug":"7534-2","status":"publish","type":"post","link":"https:\/\/unmz.gov.cz\/en\/7534-2\/","title":{"rendered":"The common specifications for non-therapeutic use devices under Annex XVI of the MDR have been published in the Official Journal of the European Union."},"content":{"rendered":"<p>Two Commission Implementing Regulations (EU) were published on 2 December 2022<\/p>\n<ul>\n<li>2022\/2346 laying down common specifications for the product groups without an identified medical purpose listed in Annex XVI to Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices<\/li>\n<li>2022\/2347 laying down detailed rules for the implementation of Regulation (EU) 2017\/745 of the European Parliament and of the Council as regards the reclassification of groups of certain active products without an intended medical purpose<\/li>\n<\/ul>\n<p>Both Regulations enter into force on the twentieth day after their promulgation (22 December 2022). However, Regulation No 2022\/2346 shall apply from 22 June 2023, except for the provisions of Article 2(3), which shall apply from 22 December 2022. This is a transitional provision for products with a valid certificate under Directive 93\/42\/EEC covered by this Regulation.<\/p>\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/CS\/AUTO\/?uri=uriserv:OJ.L_.2022.311.01.0060.01.CES&amp;toc=OJ:L:2022:311:FULL\">Commission Implementing Regulation (EU) 2022\/2346 of 1 December 2022 laying down common specifications for the product groups 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<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/CS\/AUTO\/?uri=uriserv:OJ.L_.2022.311.01.0094.01.CES&amp;toc=OJ:L:2022:311:FULL\">Commission Implementing Regulation (EU) 2022\/2347 of 1 December 2022 laying down detailed rules for the implementation of Regulation (EU) 2017\/745 of the European Parliament and of the Council as regards the reclassification of groups of certain active products without an identified medical purpose<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Dne 2. 12. 2022 byly zve\u0159ejn\u011bny dv\u011b prov\u00e1d\u011bc\u00ed na\u0159\u00edzen\u00ed Komise (EU) 2022\/2346, kter\u00fdm se stanov\u00ed spole\u010dn\u00e9 specifikace pro skupiny v\u00fdrobk\u016f bez ur\u010den\u00e9ho l\u00e9\u010debn\u00e9ho \u00fa\u010delu uveden\u00e9 v p\u0159\u00edloze XVI na\u0159\u00edzen\u00ed Evropsk\u00e9ho parlamentu a Rady (EU) 2017\/745 o zdravotnick\u00fdch prost\u0159edc\u00edch 2022\/2347, kter\u00fdm se stanov\u00ed prov\u00e1d\u011bc\u00ed pravidla k na\u0159\u00edzen\u00ed Evropsk\u00e9ho parlamentu a Rady (EU) 2017\/745, pokud jde o [&hellip;]<\/p>\n","protected":false},"author":24,"featured_media":4790,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_robots_imageindex":"","_seopress_robots_snippet":"","_seopress_robots_primary_cat":"","_seopress_robots_breadcrumbs":"","_seopress_robots_freeze_modified_date":"","_seopress_robots_custom_modified_date":"","_seopress_robots_canonical":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_fb_img":"","_seopress_social_fb_img_attachment_id":0,"_seopress_social_fb_img_width":0,"_seopress_social_fb_img_height":0,"_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_seopress_social_twitter_img":"","_seopress_social_twitter_img_attachment_id":0,"_seopress_social_twitter_img_width":0,"_seopress_social_twitter_img_height":0,"_seopress_redirections_value":"","_seopress_redirections_enabled":"","_seopress_redirections_enabled_regex":"","_seopress_redirections_logged_status":"","_seopress_redirections_param":"","_seopress_redirections_type":0,"_seopress_analysis_target_kw":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[2,7],"tags":[],"class_list":["post-7534","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-aktuality","category-aktuality-statniho-zkusebnictvi"],"acf":[],"modified_by":"Eva K\u016frkov\u00e1","_links":{"self":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/posts\/7534","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/comments?post=7534"}],"version-history":[{"count":0,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/posts\/7534\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/media\/4790"}],"wp:attachment":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/media?parent=7534"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/categories?post=7534"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/tags?post=7534"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}