Team NB (European Association of Medical devices Notified Bodies) has published a “position paper” regarding the designation of Notified Bodies under the AI Act. The concern of the Notified Bodies is that designation under the AI Act would add a significant impact on the NBs’ current workload and resources.

The desire would be that Notified Bodies that are already designated for MDR/IVDR could be given the ability to assess compliance under the AI Act if they demonstrate the expertise in-house, without obtaining full designation. This is to ensure that medical devices that have already been assessed for compliance by these NBs can continue to be assessed for compliance and to avoid deprivation of market access for AI-enabled devices during the designation process.