This document provides a first set of answers, that will be continuously developed
and updated, to the most frequently asked questions related to the joint application of
the AIA and the MDR or IVDR4 for manufacturers. This Frequently Asked Questions
(FAQ) document is primarily aimed at (but not limited to) medical device
manufacturers, notified bodies and competent authorities. All references to
‘manufacturer’ within the meaning of the MDR/IVDR should be understood as
references to ‘provider’ in accordance with the AIA. ‘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…
