{"id":3802,"date":"2025-06-24T12:23:33","date_gmt":"2025-06-24T12:23:33","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3802"},"modified":"2025-07-18T09:51:43","modified_gmt":"2025-07-18T09:51:43","slug":"medical-device-software-apps-what-are-the-eu-compliance-requirements","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/medical-device-software-apps-what-are-the-eu-compliance-requirements\/","title":{"rendered":"Medical device software apps: what are the EU compliance requirements?"},"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><strong>To legally publish a medical device software (MDSW) app in the EU, manufacturers must ensure full compliance with the MDR or IVDR before making the app available on a platform. This includes providing mandatory product information and aligning with MDCG 2025-4 and the Digital Services Act (DSA).<\/strong><\/p>\n<p>Medical device software (MDSW) apps are transforming healthcare delivery across the EU. But while the technology evolves rapidly, regulatory requirements continue to tighten, especially when apps are made available on digital platforms like app stores.<\/p>\n<p>With the release of <b>MDCG 2025-4<\/b>, the <b>European Medical Device Coordination Group<\/b> clarifies the obligations for manufacturers of MDSW under the MDR, IVDR, and Digital Services Act (DSA). Here&#8217;s what you need to know.<\/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\/medical-device-software-apps-what-are-the-eu-compliance-requirements\/#When_is_a_medical_device_software_app_considered_placed_on_the_EU_market\" >When is a medical device software app considered placed on the EU market?<\/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\/medical-device-software-apps-what-are-the-eu-compliance-requirements\/#What_information_must_be_provided_on_the_platform\" >What information must be provided on the platform?<\/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\/medical-device-software-apps-what-are-the-eu-compliance-requirements\/#Are_app_platforms_considered_distributors_or_intermediaries\" >Are app platforms considered distributors or intermediaries?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/medical-device-software-apps-what-are-the-eu-compliance-requirements\/#App_platform_as_intermediary_under_the_DSA\" >App platform as intermediary (under the DSA)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/medical-device-software-apps-what-are-the-eu-compliance-requirements\/#App_platform_as_distributor_or_importer\" >App platform as distributor or importer<\/a><\/li><\/ul><\/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\/medical-device-software-apps-what-are-the-eu-compliance-requirements\/#What_do_manufacturers_need_to_know_about_MDCG_2025-4\" >What do manufacturers need to know about MDCG 2025-4?<\/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\/medical-device-software-apps-what-are-the-eu-compliance-requirements\/#Have_questions_about_MDR_IVDR_or_MDCG_guidance\" >Have questions about MDR, IVDR or MDCG guidance?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"When_is_a_medical_device_software_app_considered_placed_on_the_EU_market\"><\/span>When is a medical device software app considered placed on the EU market?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>If you upload a MDSW app to an online platform that act is considered <strong>placing the product on the EU market<\/strong>.<\/p>\n<p>Even if the app is free, this step marks the point at which <strong>full compliance with MDR or IVDR is required<\/strong>. The app must meet all regulatory, safety, and information standards before it becomes accessible to users.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"What_information_must_be_provided_on_the_platform\"><\/span>What information must be provided on the platform?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>To comply with EU law, <b>manufacturers must ensure that key product information is displayed clearly and accessibly on the app platform<\/b>. This includes:<\/p>\n<ul>\n<li>Name and contact details of the manufacturer<\/li>\n<li>MD or IVD symbol<\/li>\n<li>Unique Device Identifier (UDI-DI)<\/li>\n<li>Intended purpose of the app<\/li>\n<li>Warnings or precautions<\/li>\n<li>Link to electronic instructions for use (eIFU)<\/li>\n<li>Single Registration Number (SRN)<\/li>\n<li>Name and address of the authorised representative (if applicable)<\/li>\n<li>Notified body number and CE certificate (if applicable)<\/li>\n<\/ul>\n<p>Platforms must be structured to allow this information to be shown in a consistent and user-friendly way.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Are_app_platforms_considered_distributors_or_intermediaries\"><\/span>Are app platforms considered distributors or intermediaries?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>This depends on how the platform is involved in making the app available.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"App_platform_as_intermediary_under_the_DSA\"><\/span>App platform as intermediary (under the DSA)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>If the platform <strong>only hosts<\/strong> third-party MDSW apps, acting as a neutral intermediary between manufacturers and users, it falls under the DSA as a <strong>hosting service<\/strong> or <strong>online platform<\/strong>. In this case, it is <strong>not<\/strong> considered an economic operator (like a distributor or importer).<\/p>\n<p>Even so, these platforms must:<\/p>\n<ul>\n<li>allow national authorities to issue takedown orders for non-compliant apps<\/li>\n<li>enable traders to present product information as required by EU law<\/li>\n<li>conduct risk assessments if classified as Very Large Online Platforms (VLOPs)<\/li>\n<\/ul>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"App_platform_as_distributor_or_importer\"><\/span>App platform as distributor or importer<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>If the platform <strong>takes part in placing the app on the market, <\/strong>for example, by taking ownership, distributing directly, or acting as an EU-based channel for a non-EU manufacturer, it is considered a <strong>distributor or importer<\/strong> under the MDR\/IVDR.<\/p>\n<p>This means it is directly responsible for:<\/p>\n<ul>\n<li>verifying compliance of the app<\/li>\n<li>cooperating with EU competent authorities<\/li>\n<li>ensuring that appropriate documentation is available<\/li>\n<\/ul>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"What_do_manufacturers_need_to_know_about_MDCG_2025-4\"><\/span>What do manufacturers need to know about MDCG 2025-4?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>This new guidance document brings much-needed clarity to the intersection between medical device law and digital platforms. It highlights the <strong>shared responsibility<\/strong> between manufacturers and platforms to ensure that MDSW apps meet all legal requirements before being offered to EU users.<\/p>\n<p>As a manufacturer, you cannot assume that compliance ends after development. You must also:<\/p>\n<ul>\n<li><b>Validate how your app is presented on each platform<\/b><\/li>\n<li><b>Ensure your economic operators are properly documented<\/b><\/li>\n<li><b>Monitor your listings for completeness and accuracy<br \/>\n<\/b><\/li>\n<\/ul>\n<p>Whether you&#8217;re developing a new MDSW app or updating an existing one, MDCG 2025-4 is a reminder that <strong>market access in the EU is tightly regulated <\/strong>and increasingly digital.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Have_questions_about_MDR_IVDR_or_MDCG_guidance\"><\/span>Have questions about MDR, IVDR or MDCG guidance?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>We help you stay on top of key regulatory developments.<\/b><\/p>\n<p><strong>For the full official guidance, see the MDCG document here:<\/strong><br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2025-4-guidance-safe-making-available-medical-device-software-mdsw-apps-online-platforms-june-2025-06-16_en\" target=\"_blank\" rel=\"noopener\"><strong><u>MDCG 2025-4 \u2013 Guidance on the safe making available of MDSW apps on online platforms<\/u><\/strong><\/a><\/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=\"MDCG 2025-4 MDSW\" title=\"MDCG 2025-4 MDSW\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/MDCG-2025-4-MDSW-.jpg\" class=\"img-responsive wp-image-3799\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/MDCG-2025-4-MDSW--200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/MDCG-2025-4-MDSW--400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/MDCG-2025-4-MDSW--600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/MDCG-2025-4-MDSW--800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/MDCG-2025-4-MDSW--1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/MDCG-2025-4-MDSW-.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;3802&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;7&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 - (7 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;Medical device software apps: what are the EU compliance requirements?&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 - (7 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-3802","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>Medical device software EU compliance guide<\/title>\n<meta name=\"description\" content=\"Understand medical device software EU compliance and how to meet MDCG 2025-4 requirements when publishing apps on platforms.\" \/>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical 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