KUALA LUMPUR, May 20 (Bernama) -- InterSystems announced that its electronic health record (EHR) solutions have received Class IIa Medical Devices certification under the European Union (EU) Medical Device Regulation (MDR) 2017/745.
The company said the approval marks what it believes is the first fully unified artificial intelligence (AI)-native EHR to achieve MDR Class IIa certification in the EU.
The certification covers InterSystems IntelliCare and InterSystems TrakCare, validating that the platforms meet stringent EU safety, quality and regulatory standards for medical technologies.
In a statement, the creative data technology provider said the milestone strengthens healthcare organisations’ ability to responsibly scale AI capabilities while maintaining confidence among clinicians, providers and regulators.
“Healthcare organisations 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 InterSystems President, Don Woodlock.
Built on TrakCare’s interoperability foundation, IntelliCare integrates AI directly into the platform’s data architecture rather than relying on standalone third-party applications.
The company said the system is designed to streamline governance, reduce clinician workloads and support safer clinical decision-making through embedded "human-in-the-loop" safeguards.
InterSystems IntelliCare includes features such as AI-generated patient summaries, clinical documentation support, conversational interfaces, and intelligent workflows.
The platform also has features such as ambient clinical orchestration capabilities that automatically capture, structure and save clinical data in real time while suggesting clinical documentation and orders for clinician approval.
The company said IntelliCare is designed to integrate seamlessly with existing healthcare information technology systems, leveraging InterSystems’ longstanding expertise in interoperability, integration and healthcare data management.
-- BERNAMA
