Why CE Marking Matters - And What It Means for AI-Driven Tools Like Dermalyser

Introduction

When it comes to medical devices, especially those powered by artificial intelligence, trust and safety are paramount. This is where CE marking plays a vital role.

CE marking is more than just a regulatory checkbox. It’s a declaration that a medical device meets the strict health, safety, and performance standards required by European regulations. For clinicians, patients, and healthcare systems, it’s a critical signal of quality, transparency, and clinical validity.

Our Approach

At AI Medical Technology, CE marking is integral to our commitment to building AI tools that truly support clinical practice. Our flagship product, Dermalyser, is a CE-marked Medical Device Software (MDSW) that uses AI to help medical professionals assess suspected skin lesions for melanoma.

Backed by a robust clinical investigation, Dermalyser achieved an AUC score of 0.96, outperforming expert dermatologists (0.85) and general practitioners (0.70). This performance, combined with CE marking, gives clinicians the confidence to trust and adopt the tool in everyday diagnostic workflows.

What Happens When AI Medical Devices Aren’t Certified?

Using an uncertified medical device, especially one involving AI, carries significant risk. Without regulatory clearance, software tools may:

• Produce unreliable or clinically unvalidated results, risking patient safety

• Lack transparency or accountability, making it unclear how recommendations are generated

• Fall short of required data privacy or cybersecurity standards

• Be prohibited from clinical use in hospitals and health systems

• Expose healthcare providers and manufacturers to legal liability

CE marking helps ensure that innovative technologies like Dermalyser aren’t just smart - they’re safe, effective, and built to perform under the scrutiny of real-world clinical care. Learn more about the science behind Dermalyser

Disclaimer: The above information does not constitute medical advice. Any questions or concerns about your health should always be directed to a qualified healthcare provider. Dermalyser has not been cleared or approved by the US Food and Drug Administration (FDA). Dermalyser is for use by qualified healthcare professionals only. The results are not intended to be the sole basis for diagnosis. Results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice.