MedTech regulator announces “Call for Evidence” on AI regulation in healthcare

Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, highlights the importance of a call for evidence on AI regulation in MedTech.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pivotal “Call for Evidence” on artificial intelligence (AI) in healthcare, inviting clinicians, industry leaders, and the public to shape the future of regulation. This marks a critical moment for medical technology stakeholders, as the UK positions itself to become a world leader in AI-enabled healthcare.

The call comes from the National Commission into the Regulation of AI in Healthcare, launched by the MHRA in September and which brings together global AI experts, clinicians, regulators, and patient advocates. The Commission’s mandate is to advise on how AI should be regulated within the UK’s healthcare system, ensuring both innovation and patient safety.

This initiative aligns with the UK’s 10-Year Health Plan and Life Sciences Sector Plan, which commit to making the NHS the most AI-enabled healthcare system globally. The MHRA acknowledges that while AI offers transformative potential – safer, faster, and more personalised care – it also presents unique regulatory challenges, including bias, transparency, and patient privacy.

For MedTech companies, this call for evidence is more than a consultation – it is an opportunity to influence the regulatory framework that will govern AI-driven devices and solutions in the UK. Key implications include:

• Market Access: Clear regulation should accelerate the safe adoption of AI technologies across the NHS, opening pathways for innovation and commercialisation.
• Patient Safety: Regulation should prioritise safety and trust, ensuring AI systems are robust, unbiased, and clinically validated.
• Global Competitiveness: By shaping world-leading standards through effective regulation, the UK can attract investment and establish itself as a hub for health-tech innovation.

For MedTech innovators, engaging with this consultation is a key opportunity to ensure that regulation fosters innovation rather than stifling it.

The MHRA is inviting submissions from clinicians, industry, healthcare providers, and the public, by the 2^nd of February 2026.

The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to [email protected].

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