The AI Act, the first of its kind in the world, will need to be fully enforced for products that come under the scope of both the Medical Device Regulation or In Vitro Diagnostics Regulation and the AI Act within three years of its publication in the Official Journal of the EU i.e. likely July/August 2027.
Does The AI Act Apply To My Medtech Product And What Do I Need To Know?
The AI Act is due for publication in July 2024. Marco Caproni of notified body, TÜV SÜD, explained how requirements over and above those in the MDR and IVDR impact medtech manufacturers.
