Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
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Italy Starts the Operational Phase of the 2026–2028 National HTA Program for Medical Devices
In January 2026, Italy officially entered the operational phase of the 2026–2028 National Health Technology Assessment Program for Medical Devices (PNHTA-DM) following the release of approximately €13 million from the national medical device governance fund. The initiative, coordinated by the National Agency for Regional Health Services (AGENAS), the program represents a key step in strengthening the national HTA framework and increasing the role of HTA in policy and procurement decisions.
Key Operational Pillars of the 2026–2028 PNHTA-DM include the following:
- Production of 50-100 HTA during 2026 on medical devices with high clinical, organizational, and economic impact, enabled by the expansion of the Register of Collaborative Centers and the activation of Framework Agreements. Special attention will be given to artificial intelligence platforms and digital therapeutics, which are increasingly present on the market and the increasing need for robust clinical and economic evidence;
- Systematic implementation of appraisal processes and the formulation of recommendations to support policy and procurement decisions;
- Launch of research projects aimed at evidence generation, with particular focus on real-world data, clinical outcomes, and value-based procurement models/.
Additional pillars include basic and advanced HTA training, the development of a national IT platform to support HTA activities, and strengthen communication and stakeholder engagement through the PNHTA Stakeholder Network, regional InfoDays, and transparency initiatives aimed at facilitating the adoption of HTA recommendations across the healthcare system.
See more details in Italian here.
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