Volume 31, Issue 2 - Medical Devices
New rules for artificial intelligence in Europe
Author: Kirsten Dahm
Abstract
The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting regulations complicate the situation further. The proposal is currently being discussed and will be applicable at the earliest in the second half of 2024, providing time for further adjustments and clarification
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