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Does The AI Act Apply To My Medtech Product And What Do I Need To Know?

 
• By Amanda Maxwell

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.

Business woman with arrows and questions sign above isolated on white background
• Source: Shutterstock/sindlera

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.

There are still many unknowns. The AI Office is now operational and work is beginning on filling in the details....

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More from Geography

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By Ashley Yeo

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.

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• By Brian Bossetta

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