Our ambition is to give an overview of the mandatory involvement of notified bodies according to the AI Act and the Machinery Regulation. Specifically, we are interested in the cases when both acts are applicable for the same product.

That said, our analysis is not to be taken as legal advice but as policy research and we recommend the reader to cross-examine our conclusions by assessing the acts in relation to the products at hand. It is also worth remembering that the focus of the analysis is when a notified body is mandatory for CE-marking a product – we do not describe what is needed to meet requirements on technology and organisation, and it is always possible to opt to include a notified body in the conformity assessment even if it is not mandatory.

Another limitation is that we do not explore the full interaction between the AI Act and the Machinery Regulation, or how they interact with other policies relevant for CE-marking products intended for EU’s internal market.

Our main conclusions of the analysis are that:

• We should not focus on how the definition of Artificial Intelligence in the AI Act relates to the concept of ”fully or partially self-evolving behaviour using machine learning approaches” as introduced by the Machinery Regulation; but instead

• We should focus on when the Machinery Regulation mandates the involvement of a notified body and how that relates to the AI Act.

We also foresee an up-coming bottleneck in the availability of notified bodies capable of performing the duties in relation to both the AI Act and the Machinery Regulation, something that can have an effect on access to the internal market.