InterSystems IntelliCare Achieves EU MDR Certification
InterSystems has achieved Class IIa Medical Device certification for its AI-native electronic health record (EHR) solutions under the EU Medical Device Regulation (EU) 2017/745. This marks the first time an AI-native EHR has received such certification in the European Union, reflecting the effectiveness and compliance of the technology in healthcare applications.
BOSTON–(BUSINESS WIRE)–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