EC adopts FAQ on the interplay between the MDR, IVDR and the AI Act

The FAQ offers practical clarification on how these regulatory frameworks complement one another and what this means for manufacturers of AI-enabled medical devices and in vitro diagnostic devices. It addresses key topics such as the scope of the legislation, conformity assessment procedures, the role of notified bodies, and the respective responsibilities under each framework.

This guidance marks an important milestone towards greater regulatory certainty, helping manufacturers better understand and prepare for compliance as AI becomes increasingly integrated into healthcare technologies.

Full information can be found here