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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.

Delays in the designation of notified bodies that can review AI-enabled medical devices in the context of the EU’s AI...

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