A recent paper published in the Journal of Law and the Biosciences maps out how the introduction of artificial intelligence (AI)-based medical devices may challenge current regulatory requirements, including the European Union’s Medical Device Regulation (MDR). The authors, who are affiliated with the Oxford Internet Institute in the United Kingdom, question the extent to which MDR requirements close the gap between AI’s expected benefits and current efforts to assess clinical utility beyond the scope of current performance algorithms. The paper recommends that the EU Commission provide further guidance on the assessment of AI-based medical devices.
