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InterSystems - Leading in Healthcare AI

InterSystems has secured MDR certification for InterSystems IntelliCare™, a next-generation EHR architected with native artificial intelligence capabilities, and InterSystems TrakCare EHR®, a unified healthcare information system used by leading healthcare systems globally. Built on TrakCare's proven interoperability foundation, IntelliCare differentiates itself by delivering AI capabilities that are fundamentally designed into the platform's centre, rather than bolted on as third-party applications.

May 19, 2026

News

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

Windsor - 19 May, 2026 - 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.

AI in Healthcare Demands Regulatory Oversight

In a healthcare environment where software increasingly influences clinical decision‑making, regulatory assurance matters. InterSystems MDR‑approved EHRs and enterprise lab solution provide healthcare organisations with confidence that their core clinical system and patient record meet Europe’s rigorous medical device requirements.

Doctors using digital tablet together in hospital

A Meaningful Differentiator in the EHR Market

Many EHRs are widely deployed, but very few have secured the level of regulatory scrutiny required for MDR approval.
InterSystems MDR‑approved EHRs sets us apart by demonstrating that:

Clinical risk is formally assessed and managed at product level
Regulatory compliance is proactive, and ongoing
Patient safety is treated as a core product responsibility, not an implementation afterthought

This is not just a certification milestone - it signals a fundamentally different approach to EHR development, and that we ensure our products meet the highest standards of safety, quality and reliability, and prioritise clinician confidence.

Over the shoulder view of a female doctor looking at brain x-ray images of male patient undergoing MRI in background at hospital. Neurologist examining patient's CAT scan images on digital table in clinic.

The EU Medical Device Regulation (MDR) sets a high bar for products that support or influence clinical care. Achieving MDR approval demonstrates that an organisation has:

Clearly defined intended use and clinical scope
Robust clinical risk management processes
Strong quality management and lifecycle controls
Evidence‑based assurance of safety and performance

For an EHR, MDR approval is not trivial. It reflects a deep, systematic approach to clinical safety and regulatory compliance — embedded into product design, development, and maintenance.

Practical Benefits for Organisations that use InterSystems EHR

Stronger Clinical Safety Assurance

Healthcare organisations gain additional confidence that the EHR supporting clinical workflows has been developed and maintained in line with medical device safety principles.

graphic of a gear with a wrench and screwdriver inside

Reduced Organisational Risk

An MDR‑approved EHR can simplify internal assurance, governance, and audit discussions by clearly demonstrating regulatory alignment at the product level.

Support for Regulatory and Governance Requirements

Organisations operating in regulated environments benefit from a vendor whose product and processes already align with MDR expectations, including documentation, change control, and post‑market considerations.

Future‑Ready Digital Infrastructure

As digital systems increasingly support clinical decision‑making, MDR alignment helps ensure long‑term regulatory resilience and preparedness for evolving requirements.

“Recognition of InterSystems electronic health records compliance with the European Medical Device Regulations celebrates over a decade of work by the Clinical Safety Team in building the company’s clinical risk management system to meet the most demanding global standards—supporting the safe, secure and effective use of patient data.”

Iain Mackenzie
Clinical Safety Team Lead, InterSystems

“MDR certification represents an important milestone in our commitment to quality, patient safety, and regulatory excellence. It strengthens the confidence our customers place in us to deliver robust, clinically safe solutions that support effective decision-making and high-quality, patient-centred care.”

Helen Grant
Product Manager, InterSystems

With InterSystems AI Applications – you are already ready to meet today and tomorrows healthcare delivery challenges

InterSystems IntelliCare: a next generation, native-AI EHR

Contact your local representative or visit InterSystems IntelliCare and InterSystems TrakCare to learn more.

Disclaimer: InterSystems® software, associated services and materials may utilize artificial intelligence. Please refer to the InterSystems AI Guidelines, Product-specific Documentation and the applicable Statement of Intended Use for more information.

InterSystems Corporation: One Congress Street, Boston, MA 02114-2010, USA. SRN: US-MF-000048003

InterSystems - Leading in Healthcare AI

AI in Healthcare Demands Regulatory Oversight

Practical Benefits for Organisations that use InterSystems EHR

Additional Product Information

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