Guidance issued by the Medicines and Healthcare Products Regulatory Agency concerning software and AI as a medical device.

Link: AI as a medical device guidance 

Topics on this page include: -  

• Innovative Devices – Software Group  

• Classify your software as a general medical device or an IVD 

• UK Regulatory Framework for Software as a Medical Device  

• Software and AI as a Medical Device Change Programme Roadmap  

• Qualification and Classification  

• Post-market and vigilance  

• Artificial Intelligence  

• Digital mental health technology  

• Collaborations