{"id":27720,"date":"2025-09-30T12:09:29","date_gmt":"2025-09-30T12:09:29","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27720"},"modified":"2026-09-03T14:08:37","modified_gmt":"2026-09-03T14:08:37","slug":"eu-borderline-manual-updated-software-examples","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/","title":{"rendered":"EU Borderline Manual Updated: Examples for Software"},"content":{"rendered":"<p>The EU Commission has published the <strong>fourth update of the Borderline Manual<\/strong> on the classification of medical devices. For software, it brings no fundamental changes compared with the MDR and MDCG 2019-11.<\/p>\n<p>The manual does, however, contain <strong>examples<\/strong> that can be relevant for manufacturers:<\/p>\n<ul>\n<li><strong>App for the prevention of sexually transmitted diseases:<\/strong>\n<p class=\"mcePastedContent\">The app described in the example stores STI test results and allows them to be shared with sexual partners via QR code. In the case of positive findings, anonymised warnings are sent within the network and users receive recommendations on prevention, testing and treatment. This does <strong>not count as medical device software<\/strong>, as it merely supports the exchange of information between users without addressing individual physiological parameters.<\/p>\n<\/li>\n<li><strong>Medical calculators:<\/strong> the app described in the example calculates medical scores, for instance to decide on anticoagulation in patients with atrial fibrillation. These can be <strong>classified as medical device software<\/strong>, even where the calculations are simple, provided the processing serves a medical purpose.<\/li>\n<\/ul>\n<p>Somewhat <strong>counterintuitively<\/strong>, an app that according to the manufacturer&#8217;s description serves <strong>prevention<\/strong> is <strong>not a medical device<\/strong> according to the manual. And this even though it contains a function for assessing the risk of having been infected with an STI.<\/p>\n<p>A simple calculator, by contrast, is classified as a <strong>medical device<\/strong> if it has medical formulas of the kind used in everyday clinical practice pre-programmed and these are then used as a basis for decisions on further treatment.<\/p>\n<p>As with other MDCG documents, this manual also points out that it is not legally binding.<\/p>\n<p class=\"last-child\">Anyone interested can find the full document here: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-september-2025-2025-09-12_en\/\" target=\"_blank\" rel=\"noopener\">Update &#8211; Manual on borderline and classification under Regulations (EU) 2017\/745 and 2017\/746 &#8211; September 2025<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27720","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>EU Borderline Manual Updated: Examples for Software<\/title>\n<meta name=\"description\" content=\"EU Borderline Manual (v4) update clarifies MDR software boundaries: prevention apps stay non-medical while simple calculators trigger medical device status.\" \/>\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\/eu-borderline-manual-updated-software-examples\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU Borderline Manual Updated: Examples for Software\" \/>\n<meta property=\"og:description\" content=\"EU Borderline Manual (v4) update clarifies MDR software boundaries: prevention apps stay non-medical while simple calculators trigger medical device status.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/\" \/>\n<meta property=\"og:site_name\" content=\"QuickBird Medical\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-03T14:08:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/08\/Social-Preview-Fallback-Image.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"3749\" \/>\n\t<meta property=\"og:image:height\" content=\"2109\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/eu-borderline-manual-updated-software-examples\\\/\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/eu-borderline-manual-updated-software-examples\\\/\",\"name\":\"EU Borderline Manual Updated: Examples for Software\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#website\"},\"datePublished\":\"2025-09-30T12:09:29+00:00\",\"dateModified\":\"2026-09-03T14:08:37+00:00\",\"description\":\"EU Borderline Manual (v4) update clarifies MDR software boundaries: prevention apps stay non-medical while simple calculators trigger medical device status.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/eu-borderline-manual-updated-software-examples\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/eu-borderline-manual-updated-software-examples\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/eu-borderline-manual-updated-software-examples\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/home-neu\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EU Borderline Manual Updated: Examples for Software\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/\",\"name\":\"QuickBird Medical\",\"description\":\"Entwicklung von medizinischer Software und DiGA\",\"publisher\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#organization\",\"name\":\"QuickBird Medical\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/wp-content\\\/uploads\\\/2022\\\/06\\\/QBM_Logo_web-01-1.webp\",\"contentUrl\":\"https:\\\/\\\/quickbirdmedical.com\\\/wp-content\\\/uploads\\\/2022\\\/06\\\/QBM_Logo_web-01-1.webp\",\"width\":875,\"height\":255,\"caption\":\"QuickBird Medical\"},\"image\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/de.linkedin.com\\\/showcase\\\/quickbird-medical\\\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"EU Borderline Manual Updated: Examples for Software","description":"EU Borderline Manual (v4) update clarifies MDR software boundaries: prevention apps stay non-medical while simple calculators trigger medical device status.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/","og_locale":"en_US","og_type":"article","og_title":"EU Borderline Manual Updated: Examples for Software","og_description":"EU Borderline Manual (v4) update clarifies MDR software boundaries: prevention apps stay non-medical while simple calculators trigger medical device status.","og_url":"https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/","og_site_name":"QuickBird Medical","article_modified_time":"2026-09-03T14:08:37+00:00","og_image":[{"width":3749,"height":2109,"url":"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/08\/Social-Preview-Fallback-Image.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/","url":"https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/","name":"EU Borderline Manual Updated: Examples for Software","isPartOf":{"@id":"https:\/\/quickbirdmedical.com\/en\/#website"},"datePublished":"2025-09-30T12:09:29+00:00","dateModified":"2026-09-03T14:08:37+00:00","description":"EU Borderline Manual (v4) update clarifies MDR software boundaries: prevention apps stay non-medical while simple calculators trigger medical device status.","breadcrumb":{"@id":"https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/quickbirdmedical.com\/en\/news\/eu-borderline-manual-updated-software-examples\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/quickbirdmedical.com\/en\/home-neu\/"},{"@type":"ListItem","position":2,"name":"EU Borderline Manual Updated: Examples for Software"}]},{"@type":"WebSite","@id":"https:\/\/quickbirdmedical.com\/en\/#website","url":"https:\/\/quickbirdmedical.com\/en\/","name":"QuickBird Medical","description":"Entwicklung von medizinischer Software und DiGA","publisher":{"@id":"https:\/\/quickbirdmedical.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/quickbirdmedical.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/quickbirdmedical.com\/en\/#organization","name":"QuickBird Medical","url":"https:\/\/quickbirdmedical.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/quickbirdmedical.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2022\/06\/QBM_Logo_web-01-1.webp","contentUrl":"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2022\/06\/QBM_Logo_web-01-1.webp","width":875,"height":255,"caption":"QuickBird Medical"},"image":{"@id":"https:\/\/quickbirdmedical.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/de.linkedin.com\/showcase\/quickbird-medical\/"]}]}},"_links":{"self":[{"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/news\/27720","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/news"}],"about":[{"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/media?parent=27720"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/categories?post=27720"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/tags?post=27720"},{"taxonomy":"display","embeddable":true,"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/display?post=27720"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}