1. Medtech Insight

New Deadlines Loom For Medtech And App Developers Under New EU AI Act

 
• By Amanda Maxwell

As the EU AI Act takes shape, critical details are emerging rapidly. However, the approaching deadlines are even more pressing. This article delves into the essential information that medtech professionals need to stay ahead.

Ducks In A Row
(Shutterstock)

A couple of new deadlines are approaching in six months’ time which need to be addressed by medtech manufacturers who have AI-enabled devices and notified bodies which intend to assess such devices.

Certain apps with clinical purposes will need to be compliant from 2 August with the Act, for example, where they qualify as medical devices that fall into Annex III (and...

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