On May 1st 2025, the National Institute for Health and Care Excellence (NICE) published its Early Value Assessment (EVA) of ‘Artificial intelligence (AI) technologies for assessing and triaging skin lesions within the urgent suspected skin cancer pathway’.
The Class III CE marking under the European Medical Device Regulation (MDR) 2017/745 reflects the highest level of regulatory scrutiny and underlines DERM’s safety, accuracy and effectiveness in detecting cancer in patients without clinician review. al decisions on skin cancer without oversight marking a transformative era for global healthcare.
Now a Class IIa medical device, DERM, uses machine learning algorithms to recognise the most common malignant, pre-malignant and benign skin lesions, including melanoma – the fifth most common cancer in the UK. Using a decade’s worth of research and development on skin lesions, it is designed to accelerate patient diagnosis and relieve pressure on the healthcare system.
In this blog as Medical Director of Skin Analytics, I wanted to share with the wider dermatology community our position regarding our regulatory status and why you can safely deploy our medical device DERM.
We believe that all responsible AI companies providing services to the healthcare sector should comply with the code of conduct and we have written our response to the NHS AI Code of Conduct.
ISO 13485:2016 is an internationally recognised quality standard for medical devices and is a pre-requisite for registration as a class II medical device under the MDR. This accreditation represents another important milestone for the company and our mission to help more people survive skin cancer.
The last thing we want to see is innovation being suppressed under volumes of red tape. At the same time, we’re trying to change healthcare, meaning that we’re dealing with people’s health and that’s not an area to “move fast and break things” for fairly obvious reasons.
