BSI have added a section on AI/ML documentation to their guidance on technical documentation submission: https://www.linkedin.com/posts/bsi-medical-devices_bsi-medical-devices-ivdr-documentation-activity-7325889686483202048-X1A1?utm_source=share&utm_medium=member_android&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben KempMay 15, 2025