MHRA publishes guidance on software and AI as a medical device 18 Apr 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on software (including artificial intelligence [AI]) regulated as medical devices. 

The MHRA highlights the outputs of its Software Group, which is responsible for developing the regulatory changes that will govern Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD). 

It builds on the organisation’s Change Programme Roadmap of October 2022 and advises that documents will be updated as progress is made. 

Find out more here.