ARTICLE SUMMARY:
The EU Parliament approved the AI Act on March 13. Excerpted from Pathways' Picks March 13: Global Regulators Meet, EU AI Act Approved, and FDA Updates.
he full European Parliament approved the AI Act March 13, clearing the way for the comprehensive, cross-industry regulatory framework to come into force. Medical devices with artificial intelligence will be subject to the new rules, including conformity assessment procedures scrutinizing algorithm training and performance. Industry hopes the requirements will be integrated into notified body assessments under the Medical Device and IVD Regulations with duplication and divergence minimized, but that can only be endured via guidance and implementation steps that are taken during the two-year transition period. Nada Alkhayat, a policy officer with the medical device branch of the European Commission, affirmed during her March 12 presentation at the IMDRF meeting that the Commission plans to issue guidance on how companies and notified bodies can address the interplay between the AI Act and the MDR/IVDR. The new law won’t be officially enacted until translation-related linguistic updates are approved and it is published in the Official Journal of the EU, expected by May.