{"id":7691,"date":"2021-08-26T16:25:41","date_gmt":"2021-08-26T13:25:41","guid":{"rendered":"https:\/\/uni-cert.ua\/?p=7691"},"modified":"2021-09-06T13:54:12","modified_gmt":"2021-09-06T10:54:12","slug":"medichni-virobi-v-nomenklaturi-farmaczevtichnih-virobnikiv-oczinka-vidpovidnosti-medichnih-virobiv-dlya-diagnostiki-in-vitro","status":"publish","type":"post","link":"https:\/\/uni-cert.ua\/en\/2021\/08\/26\/medichni-virobi-v-nomenklaturi-farmaczevtichnih-virobnikiv-oczinka-vidpovidnosti-medichnih-virobiv-dlya-diagnostiki-in-vitro\/","title":{"rendered":"Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices"},"content":{"rendered":"<p style=\"text-align: center;\"><strong>PROGRAM<\/strong><\/p>\n<p>Devices at the border of definitions:<\/p>\n<ul>\n<li>medical devices supplied with the medicinal product;<\/li>\n<li>medical devices as a means of drug delivery;<\/li>\n<li>devices, an integral part of which is a medicinal product;<\/li>\n<li>devices for IVD, RUO (research use only) and general laboratory equipment.<\/li>\n<\/ul>\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\/nikolaj-matlaev\/\" target=\"_blank\" rel=\"noopener\"><strong>Nikolay Matlaev<\/strong><\/a>, The lead auditor on certification of quality management systems and conformity assessment with technical regulations of the Ukrainian Scientific Institute of Certification<\/p>\n","protected":false},"excerpt":{"rendered":"<p>PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7847,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1,3,5],"tags":[],"class_list":["post-7691","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\/7691","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=7691"}],"version-history":[{"count":5,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/7691\/revisions"}],"predecessor-version":[{"id":7698,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/7691\/revisions\/7698"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media\/7847"}],"wp:attachment":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media?parent=7691"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/categories?post=7691"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/tags?post=7691"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}