{"id":27624,"date":"2026-06-18T10:16:10","date_gmt":"2026-06-18T10:16:10","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27624"},"modified":"2026-08-20T13:12:46","modified_gmt":"2026-08-20T13:12:46","slug":"iec-62304-edition-2-august-2026","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/iec-62304-edition-2-august-2026\/","title":{"rendered":"IEC 62304 Edition 2 Expected in August"},"content":{"rendered":"<p><strong>A revised version of IEC 62304 <\/strong>is <strong>expected <\/strong>to <strong>be published <\/strong>in <strong>August 2026<\/strong>.<\/p>\n<p>It is currently in the <strong>final coordination phase<\/strong>. A <strong>transition period of 2 to 3 years<\/strong> can be expected before regulators require compliance with the new version.<\/p>\n<p>IEC 62304 Edition 2 introduces fundamental changes:<\/p>\n<ul>\n<li>The three existing safety classes (A\/B\/C) will be <strong>replaced <\/strong>by <strong>two process rigor levels (I\/II) <\/strong>.<\/li>\n<li>In addition, there are<strong> explicit requirements for AI\/ML lifecycles<\/strong>, as well as a greater focus on cybersecurity.<\/li>\n<li>The scope is being <strong>expanded to include all health-related software and <\/strong>is no longer limited to medical devices<\/li>\n<\/ul>\n<p>For the previous SSC A, there are few changes in the equivalent Level I. <strong>The changes are most significant for manufacturers of the previous SSC B software<\/strong>, as this now falls under Level II. Here, the requirements have been raised to the new Level II, which is closely modeled after the previous SSC C.<\/p>\n<p>This blog post highlights the upcoming changes:<\/p>\n<p class=\"last-child\"><a href=\"https:\/\/meddeviceguide.com\/blog\/iec-62304-edition-2-2026-software-lifecycle-standard-update-guide\/\" target=\"_blank\" rel=\"noopener\">IEC 62304 Edition 2 (2026): Software Process Rigor Levels, AI\/ML Provisions, and What Changes for Medical Device Manufacturers | MedDeviceGuide<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27624","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>IEC 62304 Edition 2 Expected in August<\/title>\n<meta name=\"description\" content=\"IEC 62304 Edition 2 is expected in August 2026. 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