Regulating Artificial Intelligence and Machine Learning-Enabled Medical Devices in Europe and the United Kingdom

This paper reviews the key themes, challenges and potential solutions raised at two stakeholder workshops and highlights recent attempts to adapt the laws for AI-enabled medical devices (AIeMD) with a special focus on the regulatory proposals in the UK and internationally. The UK regulatory trajectory shows signs of alignment with the US thinking, and yet the European Union model is still the most closely aligned framework.

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