Not all AI is created equal. We’ve got MDR Class IIb certification.

At Infermedica, we’re proud to announce a major milestone: our Medical Guidance Platform—which includes Triage, Intake, and Follow-up—has achieved MDR Class IIb certification.

This is one of the highest possible levels of compliance for Software as a Medical Device (SaMD) in Europe. Class IIb is reserved for solutions that directly impact patient care—where accurate, reliable guidance is vital to avoid death, long-term disability, or serious health deterioration.

But… this certification isn’t just a regulatory checkbox.

It’s a validation of our ongoing commitment to safety, clinical reliability, and trust in healthcare AI. Achieving Class IIb certification acts as further proof that Infermedica is leading the way when it comes to delivering medical software that patients, physicians, and healthcare organizations can rely on.

By meeting these stringent standards, we demonstrate that AI in healthcare can be both innovative and rigorously validated, helping to set the bar for safe, trustworthy digital health solutions.

Why regulatory certifications matter for AI in healthcare

AI is transforming healthcare, but not all AI is created to the highest standards of quality and safety.

You’re probably aware of the hype around people using unregulated general-purpose LLMs, such as ChatGPT, for healthcare questions—it’s a bit like a modernized version of what we used to call “Dr. Google”. 

But even within the digital health industry, there are varying levels of regulatory certification and clinical evaluation. This makes it difficult to know which solutions you can rely on.

At Infermedica, we take a very strict approach to healthcare regulatory standards.

Achieving MDR Class IIb certification is another step that proves the reliability of Infermedica solutions. It’s a critical component in market access, ensuring product integrity and, ultimately, in helping to build trust amongst your patients and physicians.

Understanding the difference in MDR classifications

As we mentioned above, there are varying levels of MDR certification. To break it down, this table highlights how regulatory classification affects what digital health solutions can safely and legally do.

From unregulated tools to Class I, Class IIa, Class IIb, and Class III, the differences in oversight and validation influence for what, and how confidently, you can rely on a specific device.

MDR Class IIb impact on patients, physicians & organizations

While all Infermedica solutions are designed with safety and reliability in mind, achieving MDR Class IIb certification provides a clear and independent external confirmation of that quality.

For patients, this reinforces confidence in the guidance they receive. For physicians, they can put their trust in the software to support decision-making with certainty, and for healthcare organizations, they can gain assurance that the solution meets the highest standards for regulatory compliance and clinical reliability.

In short, it connects technical achievements to real-world outcomes and organizational trust.

Quality at the core

At Infermedica, quality is embedded in everything we do. We’re proud to share that our MDR Class IIb certification was achieved with zero non-conformities, reflecting the strength of our internal processes, rigorous clinical evaluation, and our team’s commitment to continuous improvement.

This level of oversight and precision provides healthcare organizations and clinicians with additional confidence that the platform they rely on has been independently evaluated for accuracy, safety, and regulatory compliance.

Looking ahead: The future of trusted AI in healthcare

MDR Class IIb certification is more than a milestone—it’s a statement about the kind of healthcare AI we aim to deliver.

But it doesn’t stop here.

With the constant evolution of both AI and regulatory expectations, this is a topic that needs continuous review, monitoring, and unwavering commitment.

As AI-powered digital tools become increasingly integrated into clinical workflows, trust, validation, and regulatory compliance are the critical differentiators you need to look out for when choosing a medical support device. 

By combining rigorous certification, peer-reviewed validation, and continuous improvement, Infermedica is helping to set the standard for safe, reliable AI in healthcare. Our vision is a future where clinicians and patients can confidently rely on AI-powered guidance as a trusted part of everyday care, and we’re doing everything in our power to make that vision a reality.

Frequently asked questions

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