‘Catastrophic’ gaps in tech regulation plans

Proposed amendments to UK medical device regulations are “a disgrace” and risk creating the lowest barrier to entry for high-risk AI devices in the developed world, sector experts have told HSJ.

Under the draft rules, which have been submitted to the World Trade Organisation ahead of being laid before Parliament, software designed to diagnose a condition can face greater regulatory scrutiny than software designed to treat one.

This means a company could deploy an AI chatbot designed to treat patients with severe mental health problems without independent regulatory scrutiny by self-certifying its own safety in the same category as a walking stick.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the market.

This was the most significant update to the UK Medical Device Regulations (MDR) 2002 since Brexit, when the UK left the EU MDR.

However, regulatory leaders have aired concerns about the draft amendments, particularly around the risk classification of software.

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Source: HSJ, 18 May 2026