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Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

approval delays
• Source: Shutterstock
Key Takeaways
  • Some member states are behind in appointing designating bodies who accredit notified bodies authorized to test AI-enabled devices.
  • Certain EU countries are not proceeding as quickly as needed with implementing national AI laws, halting progress in notified bodies’ designations.
  • There are questions over whether the fastest conformity assessment route for AI systems is, indeed, feasible.

Delays in the designation of notified bodies that can review AI-enabled medical devices in the context of the EU’s AI Act are “likely to cause a shortage of notified bodies...

That is the view of TEAM-NB, the EU notified body association, which has published a new, nine-page position paper on the European Artificial Intelligence Act providing...

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