Key points from article :
SkinVision, a Netherlands-based company, has become the first AI-powered skin cancer detection app to earn the EU’s strict Class IIa Medical Device Regulation (MDR) certification — a standard usually applied to high-grade medical devices like CT scanners. This recognition follows its earlier CE registration under the older Medical Device Directive and confirms the app’s validated medical purpose: assessing skin cancer risk from user-taken smartphone photos. The AI algorithm, built in collaboration with dermatology experts, distinguishes benign from potentially malignant moles, offering users quick, reliable risk assessments.
The certification process required SkinVision to prove consistent performance across different lighting conditions, device types, and challenging cases, while ensuring user safety. The app meets rigorous international safety, quality, and data security standards (ISO 14971, ISO 13485, ISO 27001) and has undergone independent review by EU-appointed medical technology experts. This sets a transparency and reliability benchmark in a field where many AI dermatology tools lack formal validation.
A key contributor to SkinVision’s scientific foundation has been its five-year independent research collaboration with Erasmus MC Rotterdam, led by Prof. Dr. Tamar Nijsten. Their work provided the evidence base needed for certification, demonstrating the power of public–private partnerships in advancing safe, effective digital healthcare solutions.
CEO Erik de Heus credited the company’s 3+ million users, along with hospitals, insurers, and patient organisations, for shaping the app through feedback. He emphasised that the Class IIa MDR certification not only raises the bar for AI in healthcare but also opens the door for broader integration of such tools into mainstream medical practice — signalling a new era for safe, regulated AI diagnostics.
