AI-Native EHR Achieves EU Medical Device Certification

IntelliCare is positioned as the first fully unified, AI-native EHR to achieve MDR Class IIa certification in the EU.

Built on the interoperability foundation of InterSystems TrakCare, IntelliCare is designed as a next-generation EHR with native AI capabilities. Unlike systems that rely on third-party AI add-ons, IntelliCare embeds AI directly into the platform’s data layer, enabling intelligence to be integrated across clinical workflows.

Designed to move beyond fragmented extensions, IntelliCare aims to simplify organizational oversight for governance and provide clinicians with tools intended to reduce workload and burnout. The platform delivers instant patient summaries, AI‑driven clinical documentation, full chat experiences, and intelligent workflows that maintain a “human‑in‑the‑loop” safeguard. 

Ambient clinical orchestration automatically captures, structures, and saves clinical data in real time, and suggests clinical documentation and orders for clinician approval. The system also connects with existing health information technology infrastructures, leveraging InterSystems’ experience in integration and data management.

The MDR certification signifies that the AI‑native EHR meets stringent European Union safety and quality standards. InterSystems characterizes this milestone as having important implications for responsibly scaling AI in healthcare while building confidence among providers and regulators.

“Healthcare organizations are rightfully demanding that AI be more than just an experimental add-on. By securing the EU’s first MDR certification for an AI-native EHR, we are establishing a standard that AI should be at the core of all healthcare applications,” said Don Woodlock, President, InterSystems.

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