From wellness to medical device: SkinVision raises the bar for AI in healthcare

Any medical device must first be certified for its safety and reliability before it can be rolled out for general use. In the EU, the Medical Device Regulation (MDR) Class IIa certification is the highest medical device standard for proven safety and reliability, and applies to all medical devices, from CT scan machines to syringes.

 

SkinVision, a global skin cancer app headquartered in the Netherlands, recently received the MDR class IIa certification. But, unlike those devices, the SkinVision app is downloadable to your phone and enables self-checks anytime, anywhere.

 

Navigating the EU’s toughest medical device standards

 

The MDR has fundamentally reshaped the medical software landscape, but few AI health apps have met its standards. According to a 2024 MedTech Europe survey, many manufacturers are transitioning only a fraction of their portfolios, sometimes less than 5 per cent, and large device makers are now 33 per cent less likely to launch in the EU first. A peer-reviewed analysis of over 2,000 legacy software entries shows the impact of MDR’s Rule 11: where 53 per cent of devices were previously classified as low-risk Class I, today 55 per cent are Class IIa. As a result, roughly three-quarters of existing products will require costly reclassification by 2028.

 

SkinVision was the first AI-powered medical device to receive CE registration under the EU Medical Device Directive (MDD).  It has now achieved the higher Class IIa certification under the EU Medical Device Regulation (MDR). This achievement demonstrates that AI in healthcare can meet the highest standards for safety, effectiveness and trust.

 

Raising the bar for medical-grade AI

 

“It’s groundbreaking that an AI app can now meet these high standards, paving the way for broader adoption in the health system and showing what’s possible, not just for SkinVision, but for the future of medical technology,” says Erik de Heus, CEO of SkinVision. “With this certification, SkinVision is not just raising the bar, but setting it for safe, AI-powered health tools.”

 

The MDR Class IIa is one of the strictest medical device standards in the world, and to receive certification under it, SkinVision had to clearly prove its medical purpose: detecting skin cancer risk through photos taken by the user’s mobile phone using the SkinVision app.

 

The impact on users and the healthcare industry

 

In the UK, the NHS is under significant pressure from the growing number of skin cancer cases. Non-melanoma skin cancer (NMSC)  is the most common cancer in the UK, and projections estimate that by 2025, NMSC diagnoses will approach 400,000 annually, and associated costs expected to raise from around £289–£399 million in 2020 to approximately £338–£465 million in 2025.

 

To lower the barrier to using the service, SkinVision has partnered with over 30 organisations worldwide, and it is reimbursed for over 20 million people via insurers and employers. In the UK, SkinVision partners with leading insurers such as Medicash, Health Shield and BHSF. Over 1.5 million individuals have unlimited free access to SkinVision through these insurance plans. Individuals without these plans can download SkinVision directly from the Apple App Store or Google Play Store for free and perform an assessment for as little as £5.99. Individuals can choose a SkinVision plan that suits them best, from a single check to a three-month or annual plan.

 

“This enhanced certification reinforces the value of our partnership with SkinVision in delivering cutting-edge digital health solutions,” says Paul Gambon, Sales and Marketing Director at Medicash. “With over 255,000 users screened and 1,374 clinically validated skin cancers detected, we are seeing first-hand the power of proactive, technology-driven care. This milestone reflects our commitment to harnessing innovative and pioneering technology that drives better health outcomes and ensures accessible care for all our customers.”

 

The EU MDR Class IIa certification is also recognised in several other markets that align with EU medical device regulations, including Australia, New Zealand and the UK. It also means SkinVision is no longer just a “health/wellness” app, but a certified medical device with proven safety and reliability, unlike MDR Class I devices, which are reviewed internally.

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SkinVision is a CE-certified medical device app (EU MDR Class IIa) that helps people check their skin for signs of skin cancer. By combining advanced AI technology with the expertise of dermatologists, the app provides a quick risk indication (low or high) for skin spots, helping users decide whether to seek medical advice.

 

Founded in 2012 and headquartered in Amsterdam, SkinVision has performed over six million skin checks for more than three million users worldwide. With a mission to reduce skin cancer-related deaths by 50 per cent and potentially save 250,000 lives in the coming decades, SkinVision empowers people to take control of their skin health. 

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For more information, visit skinvision.com