{"id":7700,"date":"2021-08-26T17:50:09","date_gmt":"2021-08-26T14:50:09","guid":{"rendered":"https:\/\/uni-cert.ua\/en\/?p=7700"},"modified":"2021-08-26T18:38:51","modified_gmt":"2021-08-26T15:38:51","slug":"ukchernovik","status":"publish","type":"post","link":"https:\/\/uni-cert.ua\/en\/2021\/08\/26\/ukchernovik\/","title":{"rendered":"Regulatory requirements for medical devices in laboratory practice"},"content":{"rendered":"<p style=\"text-align: center;\"><strong>PROGRAM<\/strong><\/p>\n<p>Classification: medical device for IVD, RUO (research use only) and general laboratory equipment.<\/p>\n<p>Conformity assessment through self-declaration<\/p>\n<p>Conformity assessment performed by conformity assessment body:<\/p>\n<ul>\n<li>choosing the best procedure for your business<\/li>\n<li>application and documentation<\/li>\n<li>step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities<\/li>\n<li>special procedure for III class devices, which incorporate medicines<\/li>\n<li>requirements for instruction for use and labeling<\/li>\n<\/ul>\n<p>Conformity assessment of medical devices through the recognition of EU certificates:<\/p>\n<ul>\n<li>the legislative basis of the recognition procedure and the necessary conditions<\/li>\n<li>list of required documents<\/li>\n<li>step-by-step implementation of the conformity assessment by recognition of EU certificate<\/li>\n<li>the validity period of the certificate issued by recognition and other restrictions<\/li>\n<\/ul>\n<p>Declaration of conformity<\/p>\n<p>Conducting of surveillance audits for issued certificates<\/p>\n<p style=\"text-align: justify;\"><a href=\"https:\/\/uni-cert.ua\/en\/team\/viktoriya-shevchenko\/\" target=\"_blank\" rel=\"noopener\">Viktoriia Shevchenko<\/a>, Head of Conformity Assessment Department of the Ukrainian Scientific Institute of Certification<\/p>\n","protected":false},"excerpt":{"rendered":"<p>PROGRAM Classification: medical device for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration Conformity assessment performed by conformity assessment body: choosing the best procedure for your business application and documentation step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities special procedure for III class devices, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7729,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1,3,5],"tags":[],"class_list":["post-7700","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-sobytiya","category-study"],"acf":[],"_links":{"self":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/7700","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/comments?post=7700"}],"version-history":[{"count":15,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/7700\/revisions"}],"predecessor-version":[{"id":7717,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/7700\/revisions\/7717"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media\/7729"}],"wp:attachment":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media?parent=7700"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/categories?post=7700"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/tags?post=7700"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}