Two European Parliament Committees vote to delay entry into application of AI rules for Medical Devices
The European Parliament’s Internal Market Committee and Civil Liberties Committee have voted by a substantial majority to postpone certain rules on artificial intelligence which will have an impact on medical device manufacturers.
The postponement is intended to prevent overlapping application of sector-specific safety rules, such as those provided in the MDR and IVDR, with the obligations imposed by the AI Act.
The Committees believe that obligations imposed by the AI Act could be less stringent for products, such as medical devices and IVDs, that are already regulated by sector-specific laws.