Towards a Single Regulatory Pathway for AI-Enabled Medical Technologies

We, the undersigned organisations representing healthcare professionals, researchers, innovators and industry across Europe, recognise the growing role that artificial intelligence (AI) can play in improving patient care and supporting the sustainability of healthcare systems.

As Europe faces ageing populations, growing workforce shortages and rising healthcare demand, AI-enabled medical devices and diagnostics can help support earlier diagnosis, more personalised treatment, improved clinical decision-making and more efficient care delivery. When appropriately designed, clinically validated, including by involving clinicians in their development, and responsibly deployed, AI can provide valuable support to patients and healthcare professionals across screening, medical imaging, laboratory medicine and patient monitoring1 by identifying clinically relevant patterns, improving workflows and supporting more timely and informed clinical decisions. AI-enabled medical technologies should function reliably and be user-friendly in clinical work environments, so that they support rather than hamper clinical workflows. Realising these benefits, however, requires public and professional trust and a regulatory framework that is both safe and workable, enabling timely access to innovative healthcare technologies.

[1] European Commission: Directorate-General for Health and Food Safety, PwC, EEIG and Open Evidence, [Directorate-General for Health and Food Safety, PwC, EEIG, Open Evidence], Study on the deployment of AI in healthcare – Final report, Publications Office of the European Union, 2025, https://data.europa.eu/doi/10.2875/2169577