InterSystems IntelliCare Receives EU Medical Device Certification

JAKARTA — InterSystems, a global data technology company that supports more than one billion health records worldwide, announced that its electronic health record (EHR) solutions have received Class IIa Medical Device certification under the European Union’s Medical Device Regulation (MDR) (EU) 2017/745.

With this achievement, InterSystems has become the first AI-native EHR provider to obtain Class IIa MDR certification in the European Union, marking a significant milestone for the adoption of artificial intelligence in healthcare.

The certification confirms that InterSystems’ AI-native EHR technology meets the European Union’s stringent standards for safety, quality, and regulatory compliance. The recognition is expected to strengthen trust among healthcare providers, patients, and regulators as AI becomes increasingly integrated into clinical workflows.

The milestone also comes at a time when Indonesia is accelerating healthcare digitalization through the adoption of electronic medical records and the integration of national health data via the SATUSEHAT platform. As AI adoption in healthcare continues to grow, technologies that comply with rigorous standards for safety, governance, and quality are becoming increasingly important for healthcare providers and regulators alike.

The certification covers InterSystems IntelliCare™, the company’s next-generation AI-native electronic health record platform, as well as InterSystems TrakCare®, its integrated healthcare information system used by leading healthcare institutions worldwide.

Built on the proven foundation of TrakCare, IntelliCare integrates artificial intelligence directly into the core platform, allowing healthcare organizations to leverage AI capabilities more effectively than standalone AI applications layered onto existing systems.

“Healthcare organizations should expect AI to be more than an experimental add-on,” said Don Woodlock, President of InterSystems. “By achieving the first MDR certification in the European Union for an AI-native EHR, we are setting a new standard that AI should be a core component of every healthcare application.”

Unlike solutions that simply add AI as an optional feature, IntelliCare incorporates AI as a foundational element of the platform. This approach helps healthcare providers streamline AI governance and oversight while equipping clinicians with tools designed to reduce administrative burdens and help mitigate burnout.

The platform can instantly generate patient summaries, assist with clinical documentation, provide AI-powered conversational capabilities, and support healthcare professionals in completing routine tasks more efficiently. Importantly, final clinical decisions remain under the control of qualified healthcare professionals.

One of IntelliCare’s key capabilities is its ability to automatically capture and organize clinical information during patient encounters. The system can also generate documentation suggestions and recommend clinical actions, which must be reviewed and approved by healthcare providers before implementation.

In addition, IntelliCare is designed to integrate with existing healthcare IT systems, enabling organizations to adopt advanced AI functionality without replacing their current infrastructure.

The certification further strengthens InterSystems’ position as a leading provider of enterprise-grade AI applications and healthcare technologies at a time when healthcare organizations worldwide are seeking trusted and compliant AI solutions.