{"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":"2026-09-10T11:45:41","modified_gmt":"2026-09-10T11:45:41","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 has been delayed until October 2028"},"content":{"rendered":"<p dir=\"ltr\">The publication of a revised version of <strong>IEC 62304 was originally expected in August 2026, but has been significantly delayed<\/strong>: Nearly 1,500 comments were received on the 2025 Committee Draft.<\/p>\n<p dir=\"ltr\">So far, only the second Committee Draft has been released, which means the Final Draft will not be available <strong>until 2028 at the earliest<\/strong> \u2014 the IEC currently lists October 2028 as the publication date. In addition, there will likely be a transition period of 2 to 3 years before regulators require compliance with the new version. In the medium term, therefore, the classification rules will continue to apply <a href=\"https:\/\/quickbirdmedical.com\/en\/iec-62304-software-safety-class-a-b-c\/\">as described in our guide<\/a>.<\/p>\n<p dir=\"ltr\">It&#8217;s still worth taking a look at the planned changes, because IEC 62304 Edition 2 introduces fundamental changes:<\/p>\n<ul dir=\"ltr\">\n<li>The three existing safety classes (A\/B\/C) will be replaced by two process rigor levels (I\/II).<\/li>\n<li>In addition, there are explicit requirements for AI\/ML lifecycles, as well as a greater focus on cybersecurity.<\/li>\n<li>The scope is being expanded to include all health-related software and is no longer limited to medical devices.<\/li>\n<\/ul>\n<p dir=\"ltr\">For the previous SSC A, there are few changes in the equivalent Level I. The changes are most significant for manufacturers of the previous SSC B software, 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 dir=\"ltr\">This blog post highlights the upcoming changes:<br \/>\n<a href=\"https:\/\/meddeviceguide.com\/blog\/iec-62304-edition-2-2026-software-lifecycle-standard-update-guide\/\">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 has been delayed until October 2028<\/title>\n<meta name=\"description\" content=\"The publication of a revised version of IEC 62304 was originally expected in August 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