{"id":215,"date":"2023-08-31T11:32:00","date_gmt":"2023-08-31T16:32:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=215"},"modified":"2025-06-05T15:51:49","modified_gmt":"2025-06-05T20:51:49","slug":"ivdr-class-d-devices-advanced-strategies-for-succeeding-in-a-dynamic-regulatory-environment","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/ivdr-class-d-devices-advanced-strategies-for-succeeding-in-a-dynamic-regulatory-environment\/","title":{"rendered":"IVDR Class D Devices: Advanced Strategies for Succeeding In a Dynamic Regulatory Environment"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"960\" height=\"540\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/live_70_on_demand.webp\" alt=\"recorded 31 august 2023 ivdr class d devices advanced strategies for succeeding in a dynamic regulatory environment live #70\" class=\"wp-image-254\" style=\"width:550px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/live_70_on_demand.webp 960w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/live_70_on_demand-300x169.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/live_70_on_demand-768x432.webp 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/figure>\n\n\n\n<p>Certification of Class D devices present additional challenges for manufacturer&#8217;s due to the additional requirements for these high-risk devices.<\/p>\n\n\n\n<p>The challenges are further complicated because the infrastructure required in the IVDR is not fully in place. While notified bodies are moving forward with certification of these devices, the path forward and current state of play can be confusing. The targets seem to be constantly changing, making it difficult to prepare for certification of these devices.<\/p>\n\n\n\n<p>In this Live! show we discuss:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Current status on EURLs and draft common specifications<\/li>\n\n\n\n<li>What steps notified bodies are taking in lieu of EURLs<\/li>\n\n\n\n<li>What can you do to be prepared for your technical review<\/li>\n\n\n\n<li>And much more, including answering your questions!<\/li>\n<\/ul>\n\n\n\n<p>Sign up to watch the Live! show on demand.<\/p>\n\n\n\n<p>Panelists:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Margot Borgel\u00a0\u2013 Director, IVD Intelligence &amp; Innovation<\/li>\n\n\n\n<li>Bethany Chung, Ph.D., RAC \u2013 Principal Regulatory Scientist<\/li>\n\n\n\n<li>Lindsay Wright \u2013 Senior Consultant \/ Capability Manager<\/li>\n\n\n\n<li>Nancy Morrison, RAC \u2013 Vice President, Intelligence &amp; Innovation (moderator)<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Certification of Class D devices present additional challenges for manufacturer&#8217;s due to the additional requirements for these high-risk devices. The&#8230;<\/p>\n","protected":false},"author":2,"featured_media":157,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"resource-type":[6],"topic":[9],"class_list":["post-215","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live","topic-regulatory-quality"],"acf":[],"card_info":{"title":"IVDR Class D Devices: Advanced Strategies for Succeeding In a Dynamic Regulatory Environment","link":"https:\/\/www.rqmplus.com\/resources\/ivdr-class-d-devices-advanced-strategies-for-succeeding-in-a-dynamic-regulatory-environment\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","excerpt":"Certification of Class D devices present additional challenges for manufacturer&#8217;s due to the additional requirements for these high-risk devices. 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