{"id":73933,"date":"2023-12-29T14:39:07","date_gmt":"2023-12-29T22:39:07","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=resource-page&#038;p=73933"},"modified":"2023-12-29T14:39:07","modified_gmt":"2023-12-29T22:39:07","slug":"the-new-eu-in-vitro-diagnostic-regulation-whats-changing-and-what-you-need-to-know","status":"publish","type":"resource-page","link":"https:\/\/www.jamasoftware.com\/legacy\/whitepaper\/the-new-eu-in-vitro-diagnostic-regulation-whats-changing-and-what-you-need-to-know\/","title":{"rendered":"The New EU In Vitro Diagnostic Regulation: What&#8217;s Changing and What You Need to Know"},"content":{"rendered":"<div id='av_section_1'  class='avia-section av-1xk07xh-bbbec7a78c99a3bc73edbd2023502169 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  avia-builder-el-no-sibling  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><main  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-73933'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column_table av-1izwc3p-0dd97e9e1f6b6e68ec68b331b5ba7c20 sc-av_two_fifth av-equal-height-column-flextable'><div  class='flex_column av-1izwc3p-0dd97e9e1f6b6e68ec68b331b5ba7c20 av_two_fifth  avia-builder-el-1  el_before_av_three_fifth  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle  '     ><\/div><div class='av-flex-placeholder'><\/div><div  class='flex_column av-1dfyz5x-54808b3f45749ff6a22951230de9ef19 av_three_fifth  avia-builder-el-3  el_after_av_two_fifth  el_before_av_hr  flex_column_table_cell av-equal-height-column av-align-middle  '     ><p><br \/>\n<\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ljz2oc54-f4c32aef36da49fd259c264837168768\">\n#top .hr.hr-invisible.av-ljz2oc54-f4c32aef36da49fd259c264837168768{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-ljz2oc54-f4c32aef36da49fd259c264837168768 hr-invisible  avia-builder-el-6  el_after_av_three_fifth  el_before_av_one_full '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div  class='flex_column av-wga891-b5f28f812c6cab24bcc18bf3ef4b1f27 av_one_full  avia-builder-el-7  el_after_av_hr  avia-builder-el-last  first flex_column_div  '     ><section  class='av_textblock_section av-ljz0yqe6-e711d71884095728b0d3f8bbd256b9f5 '  ><div class='avia_textblock' ><p>In May of 2022 a paradigm shift emerged in how In-Vitro Diagnostics (IVD\u2019s) will be developed, managed, and regulated in the European Union (EU). The EU Commission (CE) has developed new regulations named the In Vitro Diagnostic Regulation (IVDR) to replace the previous In Vitro Diagnostic Directive (IVDD). The main goal of the IVDR is to improve upon the quality, safety, and reliability of IVD\u2019s within the European market. This will change the current status quo as IVDR has been predicted to have a significant impact in medical device organizations with IVD sale and business operations.<\/p>\n<p><strong>In this whitepaper, we will provide: <\/strong><\/p>\n<ul>\n<li><strong>An overview of the new regulation <\/strong><\/li>\n<li><strong>Discussion some specific topics <\/strong><\/li>\n<li><strong>Considerations for organizations as they adapt to this new paradigm <\/strong><\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-73933'><div class='entry-content-wrapper clearfix'>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":171,"featured_media":73936,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"resource_type":[887],"resource_industry":[901],"primary_topic":[913,915,920],"primary_challenge":[932],"competitors":[],"partners":[],"secondary_topic":[],"secondary_challenge":[],"class_list":["post-73933","resource-page","type-resource-page","status-publish","has-post-thumbnail","hentry","resource_type-whitepaper","resource_industry-medical-devices-life-science","primary_topic-compliance-regulation","primary_topic-requirements-management","primary_topic-traceability","primary_challenge-regulatory-compliance"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - 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