{"id":28832,"date":"2026-05-07T09:35:30","date_gmt":"2026-05-07T09:35:30","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=28832"},"modified":"2026-09-03T10:18:52","modified_gmt":"2026-09-03T10:18:52","slug":"digital-omnibus-mdr-ai-act","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/digital-omnibus-mdr-ai-act\/","title":{"rendered":"Digital Omnibus, MDR, and IVDR: Changes to the AI Act"},"content":{"rendered":"<p>On March 26, 2026, the <strong>European Parliament adopted <\/strong>its position on<strong>the \u201cDigital Omnibus on AI.\u201d<\/strong>Following the Council\u2019s earlier adoption of its position, <strong>trilogue negotiations<\/strong> are now set to begin. One of the goals of the omnibus package is <strong>to reduce overlaps between the AI Act and sector-specific regulations such as the MDR and IVDR<\/strong>.<\/p>\n<p>At the same time, the proposal for targeted amendments to the MDR and IVDR provides that the Commission will have <strong>greater flexibility in adapting <\/strong>the <strong>essential safety and performance requirements<\/strong> (Annex I) <strong>in the future <\/strong>. For AI-related aspects, the requirements of the AI Act are to be taken into account.<\/p>\n<p class=\"last-child\">You can read the text here: <a href=\"https:\/\/www.europarl.europa.eu\/doceo\/document\/TA-10-2026-0098_EN.html\" target=\"_blank\" rel=\"noopener\">Texts Adopted &#8211; Simplification of the Implementation of Harmonized Rules on Artificial Intelligence (Digital Omnibus on AI) &#8211; Thursday, March 26, 2026<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-28832","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Digital Omnibus, MDR, and IVDR: Changes to the AI Act<\/title>\n<meta name=\"description\" content=\"The EU Parliament has adopted its position on the Digital Omnibus. The trilogue is intended to resolve overlaps between AI Act, MDR &amp; IVDR.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quickbirdmedical.com\/en\/news\/digital-omnibus-mdr-ai-act\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Digital Omnibus, MDR, and IVDR: Changes to the AI Act\" \/>\n<meta property=\"og:description\" content=\"The EU Parliament has adopted its position on the Digital Omnibus. The trilogue is intended to resolve overlaps between AI Act, MDR &amp; IVDR.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/quickbirdmedical.com\/en\/news\/digital-omnibus-mdr-ai-act\/\" \/>\n<meta property=\"og:site_name\" content=\"QuickBird Medical\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-03T10:18:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/08\/Social-Preview-Fallback-Image.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"3749\" \/>\n\t<meta property=\"og:image:height\" content=\"2109\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/digital-omnibus-mdr-ai-act\\\/\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/digital-omnibus-mdr-ai-act\\\/\",\"name\":\"Digital Omnibus, MDR, and IVDR: Changes to the AI Act\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#website\"},\"datePublished\":\"2026-05-07T09:35:30+00:00\",\"dateModified\":\"2026-09-03T10:18:52+00:00\",\"description\":\"The EU Parliament has adopted its position on the Digital Omnibus. 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