Today, 13 March 2024, the European Parliament approved the text of the Artificial Intelligence Act. In December 2023, Members of the Parliament endorsed the AI…
MDCG Guidance on Medical Device Software (MDSW) – Hardware combinations
The Medical Device Coordination Group (MDCG) endorsed in October 2023 a new guidance on medical devices software (MDSW) intended to work together with hardware or…
Regulatory requirements for AI medical devices
In June 2023, the European Parliament adopted its position on the Artificial Intelligence Act (AI Act). Lawmakers have already started their negotiations to define the…