{"id":3843,"date":"2025-06-30T12:17:57","date_gmt":"2025-06-30T12:17:57","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3843"},"modified":"2025-07-18T09:50:10","modified_gmt":"2025-07-18T09:50:10","slug":"when-does-the-ai-act-apply-to-medical-device-software","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/","title":{"rendered":"When does the AI Act apply to medical device software?"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><b>The AI Act applies to software intended to fulfil a medical purpose, when it qualifies as an AI system and is part of a medical device or IVD subject to MDR or IVDR. Only those requiring a conformity assessment involving a notified body are considered high-risk systems under the AI Act.<\/b><\/p>\n<p>For full details, you can consult the <b><u><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2025-6-faq-interplay-between-medical-devices-regulation-vitro-diagnostic-medical-devices-2025-06-19_en\" target=\"_blank\" rel=\"noopener noreferrer\">official MDCG 2025-6 guidance on the interplay between MDR\/IVDR and the AI Act<\/a>.<\/u><\/b><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/#Understanding_what_counts_as_MDAI\" >Understanding what counts as MDAI<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/#When_is_an_MDAI_considered_high-risk\" >When is an MDAI considered high-risk?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/#Do_MDRIVDR_classifications_change_under_the_AI_Act\" >Do MDR\/IVDR classifications change under the AI Act?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/#How_do_the_MDR_IVDR_and_AI_Act_interact\" >How do the MDR, IVDR and AI Act interact?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/#What_happens_after_2_August_2027\" >What happens after 2 August 2027?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/#What_should_manufacturers_do_now\" >What should manufacturers do now?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/#In_summary\" >In summary<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-does-the-ai-act-apply-to-medical-device-software\/#Need_support\" >Need support?<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Understanding_what_counts_as_MDAI\"><\/span>Understanding what counts as MDAI<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Medical Device Artificial Intelligence (MDAI)<\/b> refers to AI systems used in medical devices or IVDs. To fall under the AI Act, a software must meet two conditions: it must qualify as a medical device (under MDR or IVDR) and as an AI system (as defined by Article 3 of the AI Act).<\/p>\n<p>AI systems are machine-based and designed to operate with varying levels of autonomy. They use input data to generate outputs (such as predictions, recommendations or decisions) that influence physical or digital environments. This includes diagnostic tools, imaging software, or decision-support systems.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"When_is_an_MDAI_considered_high-risk\"><\/span>When is an MDAI considered high-risk?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Not all MDAI are classified as high-risk under the AI Act.<\/p>\n<p>Only those that are part of medical devices or IVDs requiring a conformity assessment with the involvement of a notified body are considered high-risk systems. This includes:<\/p>\n<ul>\n<li>MDR class IIa, IIb, and III devices<\/li>\n<li>IVDR class B, C, and D devices<\/li>\n<\/ul>\n<p>MDR class I and IVDR class A devices, which follow self-declaration procedures, are not considered high-risk under the AI Act, unless they are included under other high-risk categories listed in Annex III.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Do_MDRIVDR_classifications_change_under_the_AI_Act\"><\/span>Do MDR\/IVDR classifications change under the AI Act?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>No. The AI Act does not affect how a product is classified under MDR or IVDR. Instead, it introduces a new layer of classification for AI systems. Manufacturers must evaluate both regulatory frameworks and align their documentation accordingly.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_do_the_MDR_IVDR_and_AI_Act_interact\"><\/span>How do the MDR, IVDR and AI Act interact?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>The AI Act does not replace the MDR or IVDR, but complements them<\/b>.<\/p>\n<p>It adds specific requirements for high-risk AI systems, with the goal of improving their safety, reliability and transparency throughout the entire lifecycle. <b>In particular, the AI Act introduces additional obligations in areas already covered by MDR and IVDR, such as:<\/b><\/p>\n<ul>\n<li><b>Lifecycle management<\/b>, with an emphasis on performance after placing on the market<\/li>\n<li><b>Quality management systems<\/b> that incorporate both MDR\/IVDR and AI Act requirements<\/li>\n<li><b>Risk analysis tailored to AI<\/b>-specific risks, such as data bias or unexpected software behaviour<\/li>\n<li><b>Transparency and human oversight<\/b>, ensuring operators can understand and manage the system\u2019s outputs<\/li>\n<li><b>Accuracy, robustness and cybersecurity<\/b>, especially in real-world conditions and over time<\/li>\n<\/ul>\n<p>These obligations must be incorporated into the existing compliance framework through targeted updates to the technical documentation, risk files and quality systems. The objective is to build a harmonised and consistent approach to regulatory compliance under both MDR\/IVDR and the AI Act.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_happens_after_2_August_2027\"><\/span>What happens after 2 August 2027?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>This date marks the full application of the AI Act<\/b>. If a medical device or IVD is placed on the market or put into service on or after 2 August 2027, the AI Act applies fully, including its requirements for high-risk systems.<\/p>\n<p>If the device was placed on the market before that date, the AI Act only applies in case of significant changes to the AI system\u2019s design made after 2 August 2027. Changes made before that date do not trigger AI Act obligations.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_should_manufacturers_do_now\"><\/span>What should manufacturers do now?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Although some obligations apply later, the transition period is already underway.<br \/>\n<span style=\"background-color: rgba(0, 0, 0, 0);\"><b>Manufacturers should begin evaluating their portfolios, identifying which products include AI systems and whether those qualify as high-risk<\/b>. A practical next step is to carry out a gap analysis to map current MDR or IVDR documentation against the new requirements introduced by the AI Act.<\/span><\/p>\n<p><b>Areas that deserve particular attention include:<\/b><\/p>\n<ul>\n<li>Quality management and risk procedures<\/li>\n<li>Bias detection and mitigation strategies<\/li>\n<li>Transparency and human oversight controls<\/li>\n<li>Validation and performance testing documentation<\/li>\n<li>Post-market monitoring and traceability<\/li>\n<\/ul>\n<p>Integrating these elements early will reduce regulatory friction later and help manufacturers maintain market access in the long term.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"In_summary\"><\/span>In summary<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The AI Act applies from 2 August 2027 to medical devices and IVDs with high-risk AI systems. Only devices involving notified body assessments fall under this category.<\/p>\n<p>The AI Act does not affect MDR or IVDR classifications, but it adds new obligations. Early planning is key to ensure a smooth transition and avoid compliance delays.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Need_support\"><\/span>Need support?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The European regulatory landscape is constantly evolving. If you manufacture medical devices or IVDs and want to stay aligned with the latest requirements, get in touch.<b> Our team constantly monitors updates and helps you navigate both obligations and opportunities.<\/b><\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1640\" height=\"924\" alt=\"AI Act and MDAI\" title=\"AI Act and MDAI\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/AI-Act-and-MDAI.jpg\" class=\"img-responsive wp-image-3839\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/AI-Act-and-MDAI-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/AI-Act-and-MDAI-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/AI-Act-and-MDAI-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/AI-Act-and-MDAI-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/AI-Act-and-MDAI-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/AI-Act-and-MDAI.jpg 1640w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;3843&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;5&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;5\\\/5 - (5 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;When does the AI Act apply to medical device software?&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (5 votos)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3843","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>AI Act and Medical Devices: What you need to know<\/title>\n<meta name=\"description\" content=\"Find out when the AI Act applies to medical devices and how it aligns with MDR and IVDR. 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