regulatory updates on EU digital health laws. Provide ongoing coverage of European policy impacting wearable devices, AI algorithms, and data privacy.
EU digital health regulatory update sources
Below is a curated list of official EU sources for monitoring policy affecting wearables, AI-enabled health software, and health data governance. I grouped the keepers into MDR and wearable-device rules, AI Act implementation, and EHDS or GDPR-related health-data governance.
Wearables, MDR, IVDR, and device classification
Official Commission pages and documents for medical-device and in vitro diagnostic rules, including the latest classification guidance and the 2026 EUDAMED milestone. These are the most relevant sources for wearable devices that may qualify as medical devices or software as a medical device.
europa.eu
europa.eueuropa.eueuropa.eueuropa.eueuropa.euAI Act and health-related high-risk AI
Commission and EU AI governance pages covering high-risk AI classification, implementation guidance, governance, and consultation activity. These are the key sources for health-related algorithms, including AI embedded in medical software, and they distinguish binding law from guidance and draft measures.
europa.eueuropa.eueuropa.eueuropa.eueuropa.eueuropa.eueuropa.euEHDS, GDPR, and health-data governance
European Commission, EDPB, and EDPS sources on the European Health Data Space, health-data interoperability, secondary use, and data-protection questions relevant to wearables and AI-enabled health services. This group also includes recent supervisory opinions and consultation material.
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