InterSystems IntelliCare Becomes The First AI-Native EHR To Achieve EU Medical Device Regulation Certification

BOSTON, May 20 (Bernama) -- 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.

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.