Daniel Torres Gonçalves
January 13, 2025
Artificial intelligence and medical devices: The challenges of regulations for companies
Regulation (EU) 2024/1689 of the European Parliament and of the Council (the AI Regulation) is introducing significant changes in a number of areas, including the medical devices sector. Indeed, there are a growing number of devices that incorporate Artificial Intelligence (AI) processes, such as diagnostic imaging systems, remote patient monitoring devices and clinical decision support algorithms, which will be impacted by this new regime.
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