InterSystems IntelliCare Becomes the First AI-Native EHR to Achieve EU Medical Device Regulation Certification

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Bibliographic Details
Title: InterSystems IntelliCare Becomes the First AI-Native EHR to Achieve EU Medical Device Regulation Certification
Authors: InterSystems
Source: Business Wire (English). 05/19/2026.
Abstract: 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. [ABSTRACT FROM PUBLISHER]
Database: Regional Business News
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Abstract: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. [ABSTRACT FROM PUBLISHER]