Class IIa Certified: A Major Milestone for Healthily

Healthily is proud to announce that its Dot™ AI Medical Assessment is now a Class IIa certified medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745)(EU MDR).

This is a rare and significant achievement that allows us to truly claim we can deliver the Right Care, First Time. Safely.

After 18 months of rigorous work – including independent clinical safety reviews, technical documentation, testing, and audits – Healthily has become the first UK AI navigation platform, and one of only four digital health navigation platforms in the world, to attain this level of regulatory approval.  (Other holders include Ada (Germany), Xund (Austria), Visiba (Sweden))

This milestone reflects the company’s ongoing commitment to ensuring that every interaction with the Dot™ AI Medical Assessment meets the highest standards of medical safety, precision, and reliability.

In addition, Healthily has achieved ISO 13485 certification, the global standard for Quality Management Systems for medical devices. This means that every aspect of our product development, maintenance, and operations, adheres to a robust quality framework built specifically for the medical sector.

Why Certification Matters

In a digital health environment saturated with consumer-grade tools and unregulated chatbots, Class IIa certification serves as a crucial distinction. It demonstrates that the Dot™ AI Medical Assessment:

• Delivers clinically reliable information in line with evidence-based medical guidelines

• Has undergone extensive regulatory scrutiny and quality assurance

• Is designed to complement clinical guidance, not just wellness or lifestyle support

• Offers confidence to clinicians, insurers, regulators, and most importantly, users.

Certification is not a formality. It is a rigorous process that ensures every clinical outcome supported by the Healthily system is based on tested algorithms, documented logic, and verifiable safety protocols.

Built for Health Navigation

With the growing popularity of large language models (LLMs) like ChatGPT, there is understandable interest in using AI for health information. However, these systems are not medical devices, nor are they designed or trained to deliver regulated clinical guidance.

The Dot™ AI Health Navigation Platform was purpose-built for medical navigation. Unlike general-purpose AI, it offers:

• Transparent, explainable guidance rooted in established clinical guidelines

• Controlled and curated sources – no open web or uncontrolled data inputs

• 100% evidence-based content, peer-reviewed and maintained by medical experts

• Structured red flag question protocols to identify high-risk or emergency cases

• The ability to account for co-morbidities 

• Every recommendation is grounded in validated clinical explainable logic

These features are not just technical enhancements; they are essential safeguards that protect patients and ensure that AI used in healthcare is truly fit for purpose.

Why Medical-Grade Navigation

Health systems around the world face significant pressure: growing demand, clinical workforce shortages, and increasing inefficiencies in how care is accessed and delivered.

Digital health tools are widely viewed as part of the solution, but not all tools are equal. A regulated, medical-grade navigation platform like the Dot™ AI Medical Assessment can:

• Reduce avoidable emergency visits

• Improve navigation precision in primary and urgent care settings

• Inform individuals about care pathways

• Support early detection and prevention of serious conditions

• Empower individuals to manage their own health more safely

Health systems that adopt certified navigation platforms stand to improve both patient outcomes and operational efficiency. The alternative – relying on unregulated, consumer-grade tools – carries significant clinical and legal risk.

Built in the UK, Built for the NHS

Healthily is the only UK-based company with a Class IIa certified AI Medical Assessment. Our system has been built in line with NHS expectations for clinical safety, accountability, and interoperability. We believe UK health services should be empowered by solutions that are both technically excellent and locally relevant.

None of our competitors can offer:

• Alignment with UK-specific clinical pathways

• Bespoke pathways down to ICB and GP practice levels

• Alignment with NICE Guidelines

• MHRA recognitions as a Class IIa Device

• Designed around the cultural and structural realities of the NHS

• Created, designed, and developed by the Healthily medical team, who are all NHS GPs

If the NHS is to lead the world in digital transformation, it should do so using technology built and regulated within its own health system.

A Team Effort

Our certification journey took more than a year, involved thousands of pages of technical and clinical documentation, and required the coordinated efforts of experts in engineering, clinical safety, quality assurance, regulatory affairs, and design.

We extend our sincere thanks to:

• HTCERT, for its  thorough and rigorous certification process under the MDR

• Ethos, for its strategic guidance and support throughout our compliance journey

• The entire Healthily team, whose dedication and attention to detail made this achievement possible

This recognition is not the end of the journey, it is the foundation on which we will build even greater levels of trust, utility, and clinical integration.

A Call to Action

Healthily is now ready to support health systems, insurers, and digital providers with a safe, proven, and medically regulated navigation platform.

Whether you are a clinical leader, digital health strategist, or policymaker, we invite you to consider the implications of using a Class IIa certified, UK-recognised, evidence-based AI platform as part of your patient engagement and triage strategy.

To learn more about how the Dot™ AI Medical Assessment can be integrated into your care model, or to arrange a demonstration, please get in touch info@healthily.ai.

Healthily. The Right Care. First Time. Safely.