Comment by Team-NB

Conformity assessment of MDAI will follow the procedures established under MDR and IVDR (Art. 43(3)). This will allow both, manufacturers and NBs to focus on new requirements of the AI Act. As there is already substantial expertise and experience on both sides, we foresee the challenges of the conformity assessment of high-risk MDAI to be of administrative and legal nature. [...] Timelines for the finalisation of harmonised standards under the AIA are already delayed. Efficient development and conformity assessment of innovative MDAI relies greatly on their availability. [...] In summary, the implementation of the AI Act in the medical device sector hinges on successful completion of these challenges. Clear definitions, timely national laws, availability of designating authorities, robust data security, integrated reporting systems, consideration of fundamental rights, and availability of harmonized standards are essential for smooth and effective conformity assessments and ensuring access to advanced medical technology. Unverified source (2025)