With Ministerial Decree dated December 29, 2023, the Italian Ministry of Health has established criteria and methods for feeding the fund dedicated to the governance of medical devices, the so-called “Fondo per il governo dei dispositivi medici” (Fund for medical devices governance, “Fund”).

Key Features

• Annual payment obligation.  Companies manufacturing or distributing medical devices, large medical equipment and in vitro diagnostic medical devices must pay a sum equal to 0.75% of the company’s previous year turnover from the sale of such devices to the National Health Service, net of VAT.

• Annual Declaration Requirement.  Companies must submit an annual statement to the Ministry of Health regarding:
  • The estimated amount of 0.75% of the above-mentioned turnover.
  • The company’s previous year turnover to the National Health Service, net of VAT;
• Use of the Fund. The Fund will be used for various activities related to Health Technology Assessment and governance of medical devices (including the management of the National Price Observatory, the vigilance system and the market surveillance system).
• Deadlines and next steps. The first deadline for compliance with the fund regulations is set for December 31, 2024.

Companies are currently assessing whether the Fund can be challenged in court with arguments that may be similar to those raised in the so called “payback” litigation, which will see its day in Court (namely, the Italian Constitutional Court) on May 22, 2024.