Achieving MDR Class IIa certification – the highest medical device standard for proven safety and reliability, marks official medical approval for SkinVision’s AI-powered skin cancer detection.
Amsterdam, August 5, 2025, SkinVision, a global skin cancer app headquartered in the Netherlands, 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 certification applies to all medical devices in the EU, from CT scan machines to syringes. Unlike those devices, the SkinVision app is downloadable on your phone and enables self-checks anytime, anywhere.
Raising the Bar for Medical-Grade AI
The SkinVision app combines powerful AI technology with dermatology expertise to assess suspicious skin spots quickly and accurately. The algorithm distinguishes between benign and potentially malignant moles, giving users a reliable risk indication. To receive certification under one of the strictest medical device standards in the world (EU MDR Class IIa), 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. In a market where most AI dermatology apps offer little transparency about their performance or medical reliability, SkinVision sets a new standard, showing that AI in healthcare can meet the highest bar for safety, effectiveness, and trust.
Built for Trust: Validated by Experts, Designed for Safety
The app has been clinically validated and proven to be safe and reliable. It follows international risk management standards (ISO 14971) and is built using certified quality and security systems (ISO 13485 and ISO 27001), ensuring strong product performance, data protection, and cybersecurity. An independent team of EU-appointed medical technology experts has reviewed the app and confirmed that it demonstrates consistent performance across edge cases, device types, and lighting conditions, without ever compromising user safety.
Strong Scientific Foundation Through Erasmus MC Collaboration
Since its inception, SkinVision has maintained a strong focus on independent research. Over the past five years, the app has collaborated intensively with Erasmus MC Rotterdam. This research was conducted independently. Prof. Dr. Tamar Nijsten of Erasmus MC Rotterdam says, about the certification:
“The EU MDR Class IIa certification SkinVision has now received is the recognition of the fundamental research we conducted together. Our work laid the foundation for this success. The MDR Class IIa certification also highlights the strength of our public-private partnership and the value of working together to advance digital healthcare.”
CEO Statement
Erik de Heus, CEO of SkinVision, states:
“We were able to achieve this thanks to our 3+ million users, hospitals, insurers, and patient organizations, whose valuable feedback helped us become an accurate and reliable service. 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. With this certification, SkinVision is not just raising the bar, but setting it for safe, AI-powered health tools.”
About SkinVision
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 5 million skin checks for more than 3 million users worldwide. With a mission to reduce skin cancer-related deaths by 50 percent and potentially save 250,000 lives in the coming decades, SkinVision empowers people to take control of their skin health.
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