{"id":224706,"date":"2026-06-02T15:37:00","date_gmt":"2026-06-02T19:37:00","guid":{"rendered":"https:\/\/testing.news-you-need.com\/index.php\/2026\/06\/02\/eu-commission-drafts-guidelines-on-classifying-high-risk-systems-under-the-ai-act\/"},"modified":"2026-06-02T15:55:16","modified_gmt":"2026-06-02T19:55:16","slug":"eu-commission-drafts-guidelines-on-classifying-high-risk-systems-under-the-ai-act","status":"publish","type":"post","link":"https:\/\/testing.news-you-need.com\/index.php\/2026\/06\/02\/eu-commission-drafts-guidelines-on-classifying-high-risk-systems-under-the-ai-act\/","title":{"rendered":"EU Commission drafts guidelines on classifying high-risk systems under the AI Act"},"content":{"rendered":"<p><a href=\"https:\/\/www.raps.org\/resource\/eu-commission-drafts-guidelines-on-classifying-high-risk-systems-under-the-ai-act.html\">EU Commission drafts guidelines on classifying high-risk systems under the AI Act<\/a><\/p>\n<p><a href=\"https:\/\/www.raps.org\/resource\/eu-commission-drafts-guidelines-on-classifying-high-risk-systems-under-the-ai-act.html\">https:\/\/www.raps.org\/resource\/eu-commission-drafts-guidelines-on-classifying-high-risk-systems-under-the-ai-act.html<\/a><\/p>\n<p>Publish Date: <a href=\"publish_date]\">2026-06-02 15:37:00<\/a><\/p>\n<p>Source Domain: <a href=\"www.raps.org\">www.raps.org<\/a><\/p>\n<p>Here are seven key points from the article summarizing guidelines from the European Commission on the classification of high-risk AI-integrated medical devices under the EU&#8217;s Artificial Intelligence Act:<\/p>\n<p>1. The European Commission has drafted guidelines to support companies in determining if their products containing AI components, particularly medical devices, are classified as high-risk under the AI Act.<\/p>\n<p>2. These high-risk classifications will layer on existing obligations under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) but will not replace them.<\/p>\n<p>3. The AI Act aims to govern and encourage the development of &#8220;human-centric and trustworthy&#8221; AI for medical purposes, including in vitro diagnostics and other medical devices.<\/p>\n<p>4. The AI Act will come into effect on 2 December 2027 for stand-alone high-risk AI systems and on 2 August 2028 for AI systems embedded in products.<\/p>\n<p>5. The Commission published three guidelines to explain its interpretation of high-risk products, focusing on general principles for classification, and addressing the content of Annex 1 and Annex III in the AI Act.<\/p>\n<p>6. According to Nils L\u00f6lfing, specific high-risk AI systems under the act include those with significant potential impacts on human health, safety, and fundamental rights necessitating strict compliance measures.<\/p>\n<p>7. Efforts are underway to prevent AI-integrated medical devices from being governed under multiple regulatory frameworks, such as the AI Act and the existing MDR\/IVDR, by incorporating mechanisms to eliminate redundant requirements.<br \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EU Commission drafts guidelines on classifying high-risk systems under the AI Act https:\/\/www.raps.org\/resource\/eu-commission-drafts-guidelines-on-classifying-high-risk-systems-under-the-ai-act.html Publish Date:&#8230;<\/p>\n","protected":false},"author":1,"featured_media":224709,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/www.raps.org\/static\/263d1da8-3c54-4d8a-bac72e05452e2f52\/opengraphimage_a162f340e24dc4d08dd7995529c01e82_4a7c7e45a350\/EuropeMap260528iStock.jpg","fifu_image_alt":"","footnotes":""},"categories":[14],"tags":[20],"class_list":["post-224706","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-artificial-intelligence","tag-artificial-intelligence"],"_links":{"self":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/224706"}],"collection":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/comments?post=224706"}],"version-history":[{"count":1,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/224706\/revisions"}],"predecessor-version":[{"id":224710,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/224706\/revisions\/224710"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/media\/224709"}],"wp:attachment":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/media?parent=224706"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/categories?post=224706"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/tags?post=224706"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}