New governance of medical devices presented by the Italian Ministry of Health
The Italian Ministry of Health has presented the new governance of medical devices aimed at achieving the following objectives:
- Optimization of governance activities, through strategic coordination of the collaborations actually entrusted to different bodies and the regulation of relations with the representatives of the DM area.
- Spending governance through efficient purchasing processes that are functional to the expansion of a competitive market and the consequent recovery of resources to be allocated to innovation.
- Strengthening of the surveillance and safety control system that is prevention and monitoring of incidents that occur with medical devices.
- Governance of the demand and supply of medical devices, through the early recognition of innovation and the evaluation of the additional clinical care value of innovative medical devices.
A fundamental point of the governance document is the section on the governance of supply and demand, which is almost entirely dedicated to Health Technology Assessment (HTA), a tool that favors development and innovation, safeguarding the sustainability of universal health systems and qualifying care processes.
During the presentation of the governance document, the activation of the Breast Implant Register was also announced. In this pilot phase the participation by surgeons, who implant or remove prostheses, is on a voluntary basis, subsequently the Registry will be mandatory.