AI17 The regulatory trilemma: a comparative analysis of three-tiered artificial intelligence market access in Great Britain, Northern Ireland and the Republic of Ireland

Abstract

The integration of artificial intelligence as a medical device (AIaMD) is no longer limited by technological capability but by regulatory divergence. Post-Brexit, the harmonized UK–EU market has fractured. As of 2026, dermatologists across the British Isles operate under three distinct regulatory regimes: Great Britain (GB), Northern Ireland (NI) and the Republic of Ireland (ROI). This fragmentation threatens equitable patient access to emerging diagnostic tools. In this study we evaluated the impact of this three-tiered regulatory framework shaped by the EU AI Act, the UK Medicines and Healthcare products Regulatory Agency Software and AIaMD Roadmap, and the Windsor Framework on the deployment of dermatology AI. We conducted a comparative policy analysis of medical device and AI regulations applicable in GB, NI and the ROI (2021–2026). A bottom-up economic model was used to simulate the commercialization pathway of a class IIa melanoma triage algorithm developed in London. Compliance costs were estimated using the European Commission’s AI Act Impact Assessment and Medical Device Coordination Group guidance on notified body fee structures and requirements, informed by publicly available notified body fee schedules. The model assumed duplication of UK approvals to meet EU requirements, including additional clinical evaluation, quality management system audits, dataset bias remediation and Fundamental Rights Impact Assessments. The analysis demonstrates a structural market failure affecting NI. GB benefits from a streamlined UKCA pathway, while the ROI requires full compliance with EU-MDR and the AI Act. NI faces a regulatory ‘double lock’ with mandatory EU compliance under the Windsor Framework combined with restricted market access via UK (NI) marking. The estimated cost of duplicate EU compliance (£150 000) renders the NI and ROI markets economically unviable for many small-to-medium UK AI developers. Regulatory divergence has created a ‘technological orphan’ status for NI. Without regulatory alignment or mutual recognition, access to AI-enabled tools risks being determined by jurisdiction rather than clinical need.