As the artificial intelligence (AI) sector continues to boom, the accurate classification of devices remains a challenge for medtech SMEs, says commercial lawyer at Penningtons Manches Cooper Lisa Page.  

A specialist in the sector, Page was speaking on a panel discussing the latest updates in the regulatory process at the BioTrinity conference taking place on 23-24 April in London, UK. 

One of the challenges faced by medtech companies is whether software and artificial intelligence (AI)-based solutions should be classified as medical devices or not. Page said: “At the moment, we have guidance, but we don’t have clear legislation, and that causes quite a bit of concern amongst clients. I have a client who is saying “If I’m not a medical device, which I might not be, then I can go to market, but if I’m a medical device, my regulatory costs are going to be £100,000.” 

“That is an incredibly fundamental question for this particular organisation, and I think [it] is played out in a number of organisations,” said Page. 

She emphasised the importance of frameworks such as the innovative device access pathway (IDAP) pilot programme, which was launched by the UK government in September 2023. The aim of the programme, which is backed by £10m in funding, was to streamline the development of technologies that address the clinical needs of the National Health Service (NHS). 

“As the pilot’s completed now, hopefully that means an actual device pathway will come into force. That will be something where you have a particular device that can benefit from having this sort of additional assistance and regulatory guidance to get you through,” Page comments. 

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The panel also discussed the UK Medicines and Healthcare products Regulatory Agency (MHRA)’s regulatory reform and future structure, highlighting the importance of early engagement and understanding of new technologies like AI in both the medical device and pharmaceutical industries. 

“I think the message is that there are challenges. We’re in this area where the legislation hasn’t caught up with the way the way that we know the legislation is going. It’s a slightly sort of unclear area at the moment,” concludes Page.