AI in healthcare: the guide for care providers and manufacturers
Adopted 2026-06-20 · ≈ 1 min read · 
edited by Dirk Baaijen
Healthcare AI touches three regimes at once: the AI Act (high-risk), the MDR for medical devices, and data law (GDPR and the European Health Data Space). This guide brings together what applies to care providers and manufacturers and where to start.
Short answer: AI in healthcare rarely falls under a single rule. You face the AI Act (healthcare AI is often high-risk), the MDR when the AI is a medical device, and data law — both the GDPR and the European Health Data Space (EHDS). This guide brings the files together.
What it comes down to
For care providers and manufacturers the regimes stack: a diagnostic AI system is at once a medical device (MDR), a high-risk AI system (AI Act) and a processor of special-category personal data (GDPR/EHDS). The art is to combine them into one track, not three.
The files at a glance
- AI in healthcare: the AI Act and the MDR — the overview: the dual qualification and how the regimes connect.
- AI as a medical device: the dual conformity — how to combine the MDR and AI Act assessment via one notified body.
- The European Health Data Space (EHDS) — access to and reuse of health data, and the backbone of trustworthy healthcare AI.
Where to start
Determine the qualification of your system (medical device, Annex III, or both), combine the conformity routes, and arrange the data basis (GDPR, EHDS) with a DPIA. The free AI Act scan shows which AI obligations affect you — every result traceable to its source.
Sources
- https://eur-lex.europa.eu/eli/reg/2024/1689/oj
Regulation (EU) 2024/1689 (AI Act): high-risk AI in regulated products (Annex I) and in healthcare.
Read next
AI in healthcare: the AI Act and the Medical Device Regulation (MDR)
Medical AI often falls under two regimes at once: as a medical device under the MDR (CE marking) and as high-risk AI under the AI Act (Annex I). The regulations align the conformity assessment as far as possible. Health data is also special-category personal data under the GDPR.
AI as a medical device: the dual conformity (MDR + AI Act)
If your AI is a medical device, it must meet both the MDR (clinical evaluation, CE) and the AI Act (high-risk requirements). The regulations are meant to run together through a single conformity assessment and one notified body — not two separate tracks.
The EU declaration of conformity under the AI Act (Article 47)
The EU declaration of conformity is the written statement by which the provider itself confirms that a high-risk AI system meets the AI Act. Article 47 sets out its content, language and retention; the provider bears full responsibility for it.