Testori Coggi concluded the afternoon session by affirming the main objective of the Medical Devices Directive: to protect patients within the context of a functioning market. She touted the strengths of the EU system while also acknowledging its weaknesses. The concluding remarks were divided into four areas: robustness and transparency of the regulatory system; coordinated premarket and post marketing; financing the regulatory system; and, management of the new system. Only time and the proposed recast of the Medical Devices Directive will provide details on the vision for its implementation and how the revised EU medical device regulatory garment ultimately will be sewn by its legislative seamstresses.