{"id":1058,"date":"2019-09-03T13:18:22","date_gmt":"2019-09-03T11:18:22","guid":{"rendered":"https:\/\/unmz-wp.e-bs.cz\/?page_id=1058"},"modified":"2020-09-22T13:50:23","modified_gmt":"2020-09-22T11:50:23","slug":"diagnostic-medical-media-in-vitro","status":"publish","type":"page","link":"https:\/\/unmz.gov.cz\/en\/statni-zkusebnictvi\/stanovene-vyrobky\/diagnosticke-zdravotnicke-prostredky-in-vitro\/","title":{"rendered":"In vitro diagnostic medical devices."},"content":{"rendered":"<p>Government Order No.<a href=\"https:\/\/www.unmz.gov.cz\/files\/zku\u0161ebnictv\u00ed\/sb0027-2015.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"> 56\/2015<\/a> Sb. \/<em>PDF 7 MB\/<\/em>, on technical requirements for diagnostic medical devices.<\/p>\n<p><strong>List of bodies authorised to carry out conformity assessment activities for in vitro diagnostic medical devices<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/unmz.gov.cz\/en\/state-owned-journalism\/authorised-persons-as-designated-entities\/list-of-ao-os-and-uno\/institute-for-testing-and-certification-a-s\/\">AO 224 - Institute for Testing and Certification, a. s.<\/a><\/li>\n<\/ul>\n<p><strong>European Union<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/ec.europa.eu\/growth\/single-market\/european-standards\/harmonised-standards\/iv-diagnostic-medical-devices_en\" target=\"_blank\" rel=\"noopener noreferrer\">European Union website<\/a><\/li>\n<li><a href=\"http:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.notifiedbody&amp;dir_id=20\">Notified persons in the EU <\/a><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/growth\/single-market\/european-standards\/harmonised-standards\/iv-diagnostic-medical-devices_en\" target=\"_blank\" rel=\"noopener noreferrer\">Harmonised standards<\/a><\/li>\n<\/ul>\n<p><strong>Czech translation of the Directive<\/strong> -\u00a0<a href=\"http:\/\/eur-lex.europa.eu\/legal-content\/CS\/TXT\/PDF\/?uri=CELEX:31998L0079&amp;from=EN\" target=\"_blank\" rel=\"noopener noreferrer\">31998L0079<\/a><br \/>\n<a href=\"http:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:01998L0079-20120111\" target=\"_blank\" rel=\"noopener noreferrer\">Compiled version of Directive 31998L0079<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Na\u0159\u00edzen\u00ed vl\u00e1dy \u010d. 56\/2015 Sb. \/PDF 7 MB\/, o technick\u00fdch po\u017eadavc\u00edch na diagnostick\u00e9 zdravotnick\u00e9 prost\u0159edky. P\u0159ehled subjekt\u016f autorizovan\u00fdch k \u010dinnostem p\u0159i posuzov\u00e1n\u00ed shody diagnostick\u00fdch zdravotnick\u00fdch prost\u0159edk\u016f in vitro AO 224 - Institut pro testov\u00e1n\u00ed a certifikaci, a. s. Evropsk\u00e1 unie Str\u00e1nka Evropsk\u00e9 unie Notifikovan\u00e9 osoby v EU Harmonizovan\u00e9 normy \u010cesk\u00fd p\u0159eklad sm\u011brnice -\u00a031998L0079 Kompilovan\u00e9 zn\u011bn\u00ed [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":733,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","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":""},"class_list":["post-1058","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages\/1058","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/comments?post=1058"}],"version-history":[{"count":0,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages\/1058\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages\/733"}],"wp:attachment":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/media?parent=1058"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}