Defining the intended purpose of a medical device should be the starting point for manufacturers entering the regulatory process, yet software-based devices often have a poorly-defined intended purpose, Paul Campbell, head of software and artificial intelligence at the UK regulator, the MHRA, told a conference on 6 July.
Campbell, who has just this month been appointed to lead on software and AI at the Medicines and Healthcare products Regulatory Agency (MHRA), said that manufacturers are “encouraged to really focus on”