Provider (Art. 16)
AI-enabled medical device manufacturer: double dossier (MDR + EU AI Act Annex IV) and dual CE marking.
AI Assurance — Healthcare
Dual CE marking: AI-enabled medical device is a double conformity assessment
AI-enabled medical devices fall under MDR/IVDR and under Annex I of the EU AI Act. The evidence chain is common; the double conformity assessment is managed from a single assurance platform.
What we see in this sector
MDR technical documentation + EU AI Act Annex IV with unresolved overlaps.
ISO 14971 (medical risk management) does not cover algorithmic bias — explicit regulatory gap.
Possible double Notified Body: medical surveillance + AI body. Difficult operational coordination.
Typical use cases
- AI-assisted medical imaging diagnosis
- Clinical decision support
- Remote monitoring and triage
- Pattern detection in electronic health records
Applicable regulatory frameworks
Primary frameworks
Reglamento (UE) 2024/1689 — Reglamento de Inteligencia Artificial
Reg. (UE) 2024/1689 · Official source →
EU AI Act. Applies whenever the system operates in the EU.
MDR — Reglamento de Productos Sanitarios
Reg. (UE) 2017/745 · Official source →
Dual conformity assessment (medical + AI) for AI-enabled medical devices.
Reg. (UE) 2017/746 · Official source →
In vitro diagnostic devices with AI, dual regulatory framework.
Cross-cutting frameworks
GDPR Art. 22 — Decisiones automatizadas
Reg. (UE) 2016/679 Art. 22 · Official source →
Automated individual decisions with legal effects on people.
ISO/IEC 42001:2023 — Sistema de Gestión de IA
ISO/IEC 42001:2023 · Official source →
Voluntary AI management framework, alignable with the EU AI Act.
AI supply chain — your role determines your obligations
The EU AI Act distributes obligations by role (Arts. 16, 24, 26). In this sector each role contributes a different piece to assurance.
Integrator (Art. 24)
Distributor or hospital customisation: if clinical purpose changes, takes on provider obligations.
Deployer (Art. 26)
Hospital or health system: human oversight in clinical decisions, post-market monitoring and incident reporting.