Deployer

The AI Act's deployer is not the same as the MDR or IVDR user. A hospital using AI-based device software may be a deployer with its own AI Act duties, while the clinician using it is a user under the MDR.

‘Deployer’ defined in the Article 3(4) AIA as a natural or legal person, public authority, agency or other body using AI systems under their authority, unless the use is for a personal non-professional activity. The AIA does not define the concept of ‘user’ which is defined in the MDR/IVDR as any healthcare professional or lay person who uses a device. Therefore, the concept of ‘deployer’ under AIA cannot be understood as referring to ‘user’ under MDR/IVDR.

MDCG 2025-6 / AIB 2025-1, Introduction (citing Article 3(4) AIA)