InterSystems, a creative data technology provider powering more than one billion health records globally, today announced that its electronic health record (EHR) solutions have been certified as Class IIa Medical Devices under Regulation (MDR) certification under Regulation (EU) 2017/745. This approval marks the first fully unified AI-native EHR to achieve MDR Class IIa certification in the European Union.
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This certification demonstrates that InterSystems AI-native EHR meets stringent EU safety and quality standards. This key milestone has significant implications for how healthcare organizations can responsibly scale AI while building confidence among healthcare providers and regulators.
InterSystems has secured MDR certification for InterSystems IntelliCare™, a next-generation EHR architected with native artificial intelligence capabilities, and InterSystems TrakCare®, a unified healthcare information system used by leading healthcare systems globally. Built on TrakCare's proven interoperability foundation, InterSystems IntelliCare differentiates itself by delivering AI capabilities that are fundamentally designed into the platform's data layer, rather than bolted on as third-party applications.
“Healthcare organizations are rightfully demanding that AI be more than just an experimental add-on,” said Don Woodlock, President, InterSystems. “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.”
By moving beyond fragmented AI add-ons, InterSystems IntelliCare provides organizations with simplified oversight for their own governance, and clinicians with tools designed to reduce workload and burnout. The platform delivers instant patient summaries, AI‑driven clinical documentation, full chat experiences and intelligent workflows that maintain a critical "human-in-the-loop" safeguard. Features such as ambient clinical orchestration automatically capture, structure and save clinical data in real-time and suggest clinical documentation and orders for clinician approval. InterSystems IntelliCare also seamlessly connects with existing health IT infrastructures, leveraging InterSystems deep history in integration and data management capabilities.
