{"id":33885,"date":"2025-04-15T10:37:39","date_gmt":"2025-04-15T08:37:39","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=33885"},"modified":"2025-06-16T16:24:56","modified_gmt":"2025-06-16T14:24:56","slug":"space-european-health-data-ehds-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/04\/15\/space-european-health-data-ehds-medical-devices\/","title":{"rendered":"European Health Data Space Regulation (EHDS): New Obligations for Medical Device Manufacturers"},"content":{"rendered":"<p>With the adoption of<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/regulation-eu-2025327-european-health-data-space-and-amending-directive-201124eu-and-regulation-eu-2025-03-05_en\"> <strong>Regulation (EU) 2025\/327<\/strong><\/a> the European Union has officially established the <strong>European Health Data Space (EHDS)<\/strong>, introducing important innovations for <strong>manufacturers of medical devices and in vitro diagnostics<\/strong>.<\/p>\n<p>Regulation (EU) 2025\/327 amends Directive 2011\/24\/EU and Regulation (EU) 2024\/2847 to create a common framework for the <strong>use<\/strong> and <strong>exchange of electronic health data in the European Union.<\/strong> The Regulation was published in the Official Journal of the European Union on March 5, 2025 and entered into <strong>force on March 25, 2025<\/strong>. The first obligations will apply from<strong> March 2027<\/strong>. The implementation of the regulation will take place in <strong>stages.<\/strong><\/p>\n<p><strong>Medical devices <\/strong>claiming interoperability with<strong> Electronic Health Record (EHR)<\/strong> systems will have to demonstrate compliance with <strong>security, interoperability and logging requirements<\/strong>. To clarify, <strong>EHR systems<\/strong>, or <strong>digital health record systems<\/strong>, consist of software, or a combination of <strong>hardware and software<\/strong>, that enable the processing of electronic health data. The regulation introduces specific obligations for economic actors involved in the supply of these systems, including manufacturers, importers and distributors.<\/p>\n<p>In the event that the product falls under both the definition of<strong> EHR<\/strong> and <strong>medical device<\/strong>, it will have to comply with the requirements of both regulations, including the provisions on registration in <a href=\"https:\/\/www.thema-med.com\/en\/2025\/03\/19\/eudamed-deadlines-and-obligations-for-economic-operators\/\"><strong>EUDAMED<\/strong><\/a>.<\/p>\n<p><strong>Wellness applications<\/strong> that interact with EHRs will also be subject to a new labelling, which will have to indicate <strong>compliance <\/strong>with the common specifications under the regulation.<\/p>\n<p>In addition to fostering <strong>innovation <\/strong>and<strong> research<\/strong>, the EHDS aims to <strong>improve<\/strong> <strong>patient access to electronic health data<\/strong> (primary use) and to facilitate their use for <strong>public interest<\/strong> purposes, such as clinical trials and the development of digital solutions (secondary use).<\/p>\n<p>To support cross-border healthcare, the <strong>MyHealth@EU<\/strong> platform is planned, which will connect the digital contact points of individual <strong>Member States<\/strong>.<\/p>\n<p>For further information, the European Commission has published an <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/frequently-asked-questions-european-health-data-space-2025-03-05_en\"><strong>FAQ section<\/strong><\/a> on the European Health Data Area.<\/p>\n<p>&gt;&gt;&gt; Rely on Thema to face regulatory developments in the medical device industry with confidence: we support medical device manufacturers with <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>strategic-regulatory consulting<\/strong><\/a> made-to-measure.<\/p>\n<p>SOURCE:<\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/regulation-eu-2025327-european-health-data-space-and-amending-directive-201124eu-and-regulation-eu-2025-03-05_en?prefLang=it\">https:\/\/health.ec.europa.eu\/latest-updates\/regulation-eu-2025327-european-health-data-space-and-amending-directive-201124eu-and-regulation-eu-2025-03-05_en?prefLang=it<\/a><\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/ehealth-digital-health-and-care\/european-health-data-space-regulation-ehds_en\">https:\/\/health.ec.europa.eu\/ehealth-digital-health-and-care\/european-health-data-space-regulation-ehds_en<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><em>04\/15\/2025<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>With the adoption of Regulation (EU) 2025\/327 the European Union has officially established the European Health Data Space (EHDS), introducing important  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33848,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[1674,1672,1671,1673],"class_list":["post-33885","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-ehds-en","tag-europe","tag-healthdata","tag-newobligations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>European Health Data Space Regulation (EHDS): New Obligations for Medical Device Manufacturers - Thema Med European Health Data Space EHDS: New Obligations for Manufacturers of Medical Devices - EU Regulation 2025\/327<\/title>\n<meta name=\"description\" content=\"Learn about the new obligations for medical device manufacturers introduced by Regulation (EU) 2025\/327 on the European Health Data Space (EHDS). 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