{"id":28829,"date":"2026-05-07T09:37:08","date_gmt":"2026-05-07T09:37:08","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=28829"},"modified":"2026-09-03T10:17:27","modified_gmt":"2026-09-03T10:17:27","slug":"apple-medical-device-information-app-store","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/apple-medical-device-information-app-store\/","title":{"rendered":"Apple: Medical Device Information Required in the App Store"},"content":{"rendered":"<p>Apple has also responded to the requirements set forth in MDCG 2025-4,<strong>\u201cGuidance on the Safe Making Available of Medical Device Software (MDSW) Apps on Online Platforms<\/strong>\u201d: In the European Economic Area (EEA), the United Kingdom, and the United States, the product page will <strong>now indicate<\/strong> <strong>whether an app is considered a regulated medical device<\/strong>.<\/p>\n<p>This results in specific obligations for developers. If such an app is available in the regions mentioned, the <strong>status \u201cregulated medical device\u201d<\/strong> must be <strong>specified in App Store Connect<\/strong>. In addition, relevant regulatory information must be provided, such as contact details and safety notices.<\/p>\n<p>The disclosure requirement applies if <strong>at least one of the following criteria<\/strong> is met:<\/p>\n<ul>\n<li>The app is classified in the primary or secondary category<strong>\u201cHealth &amp; Fitness\u201d<\/strong> or <strong>\u201cMedicine.\u201d<\/strong><\/li>\n<li>The age rating questionnaire indicates that the app contains frequent <strong>references to medical or treatment-related content<\/strong>.<\/li>\n<\/ul>\n<p>For new apps, this requirement is <strong>now mandatory for distribution in <\/strong>the affected regions. Existing apps must update their status by early 2027. If this deadline is not met, no further updates may be submitted.<\/p>\n<p>If an app is not classified as a regulated medical device, you can indicate this by selecting \u201cNo\u201d in App Store Connect.<\/p>\n<p class=\"last-child\">Apple provides more information on this topic at this link: <a href=\"https:\/\/developer.apple.com\/news\/?id=nyqbfz1y\" target=\"_blank\" rel=\"noopener\">Update on regulated medical device apps in the European Economic Area, the United Kingdom, and the United States &#8211; Latest News &#8211; Apple Developer<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-28829","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>Apple: Medical Device Information Required in the App Store<\/title>\n<meta name=\"description\" content=\"In the future, Apple will indicate in the App Store whether an app is a regulated medical device. 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