The Artificial Intelligence Act is on the verge of being published. It should be out by the end of 2023 or by the first semester of 2024 at the latest. Many innovations have been established relating to AI regulation, from the approach to AI ethics to AI classification on the market. But are manufacturers ready for the new rules that will possibly change the way their products access the EU market? This paper argues that there still are some uncertainties related to the interpretation of the new set of rules for AI. The main focus throughout the whole paper will be on the intersection with the Medical Device Regulation. What relation will be established between the Medical Device Regulation and the AI Act? To which obligation will manufacturers have to abide by? As the AI Act establishes a new set of rules for the AI systems, manufacturers of AI medical tools should be aware currently existing flaws of the innovative EU framework, even if in some cases they may be in their favour.