{"id":27766,"date":"2025-02-26T13:17:33","date_gmt":"2025-02-26T13:17:33","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27766"},"modified":"2026-09-03T13:54:12","modified_gmt":"2026-09-03T13:54:12","slug":"new-draft-iec-62304-software-safety-classes","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/new-draft-iec-62304-software-safety-classes\/","title":{"rendered":"New Draft of IEC 62304 on Software Safety Classes Published"},"content":{"rendered":"<p><a href=\"https:\/\/quickbirdmedical.com\/en\/iec-62304-medical-device-software-app\/\"><strong>IEC 62304<\/strong>, the standard for the <strong>software development lifecycle<\/strong> for medical device software<\/a>, is to be revised. According to the website of the British Standards Institution, the current draft has been completed and was open for public comment until February 12, 2025. The revised standard could <strong>be published in the course of 2026<\/strong>.<\/p>\n<p>Based on the current draft, far-reaching changes would be included:<\/p>\n<ul>\n<li>The <strong>safety classification is being changed completely<\/strong>: classes A, B and C are being replaced by levels I and II. \u2192 <strong>Level I<\/strong> applies to software where <strong>no harm, or only negligible harm<\/strong>, is likely. This level effectively replaces the former software safety class A. \u2192 <strong>Level II<\/strong> applies to software where <strong>serious harm<\/strong> can occur. This level effectively replaces the former safety classes B and C.<\/li>\n<li>Most SaMD that <strong>currently fall under class B<\/strong> <strong>will fall into level II<\/strong>.<\/li>\n<\/ul>\n<ul>\n<li>The <strong>scope<\/strong> is being extended to cover a broader range of software. IEC 62304 <strong>now covers all health software<\/strong>, not just medical device software.<\/li>\n<\/ul>\n<ul>\n<li>No more references to ISO 13485 or ISO 14971<\/li>\n<\/ul>\n<ul>\n<li>An enormous <strong>expansion of the guidance<\/strong> in the annexes (including for <strong>AI medical device software<\/strong>)<\/li>\n<\/ul>\n<p>The last attempt at a new version of this standard did not make it to publication. That makes it all the more interesting to see <strong>how, and whether, this draft will make it to implementation<\/strong> in the summer of 2026.<\/p>\n<p class=\"last-child\">You can follow the progress of the publication process here: <a href=\"https:\/\/standardsdevelopment.bsigroup.com\/projects\/2024-03021#\/?utm_source=newsletter-quickbirdmedical\" target=\"_blank\" rel=\"noopener\">BS EN IEC 62304 ED2 BS EN 62304 Ed2. Medical device software &#8211; Software life cycle processes<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27766","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>New Draft of IEC 62304 on Software Safety Classes Published<\/title>\n<meta name=\"description\" content=\"Draft revision of IEC 62304 expands scope to all health software and replaces safety classes A, B, and C with Levels I and II.\" \/>\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\/new-draft-iec-62304-software-safety-classes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" 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