Highlights
- 2024-02-21 07:59 Well, in general, they cite each other. So the AI act cites the medical device regulation, and there are some implications. So from the AI perspective, the medical device complying with the medical device regulation requirements is necessary, not sufficient to be compliant with the AI act. And this establishes a hierarchy of text. So the AI act would be higher priority, legislative priority, than the medical device regulation, meaning that a device that is compliant with MDR would still need to comply with the rest of the AI act in order to be used as an AI medical device.