{"id":7552,"date":"2022-12-16T14:16:48","date_gmt":"2022-12-16T13:16:48","guid":{"rendered":"https:\/\/www.unmz.gov.cz\/?p=7552"},"modified":"2022-12-16T14:16:48","modified_gmt":"2022-12-16T13:16:48","slug":"unmz-alerts-new-document-mdcg","status":"publish","type":"post","link":"https:\/\/unmz.gov.cz\/en\/unmz-upozornuje-na-novy-dokument-mdcg\/","title":{"rendered":"\u00daNMZ draws attention to the new MDCG document"},"content":{"rendered":"<p>The MDCG 2022-18 explains the conditions under which Article 97 of the MDR can be applied, allowing manufacturers to continue to supply products to the market that have expired certificates issued under the MDD or AIMDD and are not yet certified under the new legislation. In this context, the existing legislation will also be modified to reflect this de facto extension of the \"legacy devices\" regime. This is a transitional solution to facilitate the transition to MDRs and IVDRs for economic operators and to avoid a shortage of medical devices on the market, in line with the recommendations set out in MDCG 2022-14.<\/p>","protected":false},"excerpt":{"rendered":"<p>Dokument MDCG 2022-18 vysv\u011btluje podm\u00ednky, za nich\u017e lze pou\u017e\u00edt \u010dl\u00e1nek 97 MDR, kter\u00fd v\u00fdrobc\u016fm umo\u017en\u00ed nad\u00e1le dod\u00e1vat na trh v\u00fdrobky, kter\u00fdm skon\u010dila platnost certifik\u00e1t\u016f vydan\u00fdch podle sm\u011brnic MDD nebo AIMDD a z\u00e1rove\u0148 prozat\u00edm nemaj\u00ed ud\u011blen certifik\u00e1t podle nov\u00e9 legislativy. V t\u00e9to souvislosti bude rovn\u011b\u017e upravena st\u00e1vaj\u00edc\u00ed legislativa tak, aby reflektovala toto faktick\u00e9 prodlou\u017een\u00ed re\u017eimu \"legacy [&hellip;]<\/p>\n","protected":false},"author":24,"featured_media":6299,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","_seopress_analysis_target_kw":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[7],"tags":[],"class_list":["post-7552","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-aktuality-statniho-zkusebnictvi"],"acf":[],"modified_by":"Eva K\u016frkov\u00e1","_links":{"self":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/posts\/7552","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=7552"}],"version-history":[{"count":0,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/posts\/7552\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/media\/6299"}],"wp:attachment":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/media?parent=7552"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/categories?post=7552"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/tags?post=7552"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}