Team-NB welcomes the Commission’s efforts to improve the regulatory framework and acknowledges the potential benefits of clear timelines.
That said, NBs have identified several challenges and risks associated with the proposal, such as complexity, feasibility, resource Constraints, Operational Flexibility and too short transition timelines: these are considered and should be replaced by realistic timelines.
Therefore, Team-NB recommends more realistic approach with the ultimate goal of ensuring patient safety and timely access to innovative medical devices.