{"id":184,"date":"2024-09-12T09:32:00","date_gmt":"2024-09-12T14:32:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=184"},"modified":"2025-07-16T05:29:21","modified_gmt":"2025-07-16T10:29:21","slug":"mdr-ivdr-amendments","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/mdr-ivdr-amendments\/","title":{"rendered":"MDR and IVDR Amendments:Strategies for Supply Interruption Compliance"},"content":{"rendered":"\n<p><em>Featuring guests from T\u00dcV S\u00dcD and Axon Science Based Lawyers<\/em><\/p>\n\n\n\n<p>Live! #82 presentation and panel&nbsp; |&nbsp; Recorded 12 September 2024<\/p>\n\n\n\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\/2025\/01\/rqm_live_82_on_demand-min.webp\" alt=\"Recorded 12 September 2024 MDR and IVDR Amendments Strategies for supply Interruption Compliance Live #82\" class=\"wp-image-185\" style=\"width:500px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/rqm_live_82_on_demand-min.webp 960w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/rqm_live_82_on_demand-min-300x169.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/rqm_live_82_on_demand-min-768x432.webp 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/figure>\n\n\n\n<p><em><strong>Available on demand.<\/strong><\/em><\/p>\n\n\n\n<p>The recently published&nbsp;<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2024\/1860\/oj\">Regulation (EU) 2024\/1860<\/a>&nbsp;amends the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) by introducing some significant changes that will impact manufacturers and the entire MedTech industry.<\/p>\n\n\n\n<p>One of the changes is the introduction of a requirement for manufacturers to inform national competent authorities in cases of supply chain interruptions, or the withdrawal from the market, of certain critical medical devices and IVDs.<\/p>\n\n\n\n<p>Join our expert panel to explore the implications of these new obligations for manufacturers and learn actionable strategies to ensure compliance.<\/p>\n\n\n\n<p>In this comprehensive discussion, our regulatory and quality experts will cover:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Impact Assessment<\/strong>: An overview of the amendments, including changes to transition timelines for IVDR and the phased rollout of EUDAMED.<\/li>\n\n\n\n<li><strong>Supply Chain Management<\/strong>: Insights into the new obligation for manufacturers to provide advanced notice of supply chain interruptions and strategies to ensure a robust and resilient supply chain.<\/li>\n\n\n\n<li><strong>Industry Perspectives<\/strong>: An examination of feedback from industry stakeholders and how companies are preparing for these regulatory changes.<\/li>\n\n\n\n<li><strong>Compliance Strategies<\/strong>: Guidance on meeting the new requirements, including implementation within your Quality Management System (QMS).<\/li>\n\n\n\n<li><strong>Quality and Regulatory Support<\/strong>: How RQM+ can support your company with regulatory change assessments, EUDAMED data management, and the implementation of new supply chain notification processes.<\/li>\n<\/ul>\n\n\n\n<p><strong>Who Should Attend:<\/strong>&nbsp;This panel discussion is ideal for regulatory affairs professionals, operations management, quality assurance professionals, production planning and supply chain managers, and MedTech manufacturers navigating the amended IVDR and MDR requirements.<\/p>\n\n\n\n<p>By attending this event, you will gain a clear understanding of the amendments to MDR and IVDR and learn practical steps and strategies to achieve compliance.&nbsp;Register now to stay ahead of these critical regulatory changes and ensure the continued success of your products in the European market.<\/p>\n\n\n\n<p>Complete the form on this page to watch the recording and download the slides.<\/p>\n\n\n\n<p>Panelists and moderator:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Erik Vollebregt \u2013 Advocaat, Axon Science Based Lawyers<\/li>\n\n\n\n<li>Heike Moehlig-Zuttermeister \u2013 Global Director In-Vitro Diagnostics, T\u00dcV S\u00dcD<\/li>\n\n\n\n<li>Donielle Johnson \u2013 Global Regulatory Affairs Executive<\/li>\n\n\n\n<li>Ed Ball \u2013 Manager, Intelligence &amp; Strategic Execution, RQM+<\/li>\n\n\n\n<li>Amie Smirthwaite, Ph.D. \u2013 Senior Vice President, Scientific Affairs, RQM+ (moderator)<\/li>\n<\/ul>\n\n\n\n<p><em>Certificate of Participation available upon request for live attendees.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Featuring guests from T\u00dcV S\u00dcD and Axon Science Based Lawyers Live! #82 presentation and panel&nbsp; |&nbsp; Recorded 12 September 2024&#8230;<\/p>\n","protected":false},"author":2,"featured_media":1439,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"resource-type":[6],"topic":[9],"class_list":["post-184","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live","topic-regulatory-quality"],"acf":[],"card_info":{"title":"MDR and IVDR Amendments:Strategies for Supply Interruption Compliance","link":"https:\/\/www.rqmplus.com\/resources\/mdr-ivdr-amendments\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/european-union-flag-gently-waving-on-a-flagpole-against-a-cloudy-sky-symbolizing-unity-and-patriotism.-1743364-scaled.jpg","excerpt":"Featuring guests from T\u00dcV S\u00dcD and Axon Science Based Lawyers Live! #82 presentation and panel&nbsp; |&nbsp; Recorded 12 September 2024...","display_date":"September 12, 2024"},"yoast_head":"<!-- This site is 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