ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country spotlighted on the cover of Market Pathways' print issue. The April/May 2025 issue features Palazzo Montecitorio, the seat of Italy's Chamber of Deputies, in Rome.
Regulation
Authority:
Ministry of Health, General Directorate of Medicines and Medical Devices
Leader: 
Orazio Schillaci, Health Minister
Points of Interest:
- Eleven Medical Device Regulation-designated notified bodies are based in Italy, more than any other EU member state.
- Italy’s Classificational Nazionale Dispositivi Medici is the basis for the European Medical Device Nomenclature that defines products codes adopted under the MDR and the IVD Regulation.
Reimbursement/HTA
Authority:
National Agency for Regional Health Services (AGENAS)
Leader: 
Giulio Siccardi, Acting Director, AGENAS
Points of Interest:
- Unveiled a medical device national health technology assessment program in 2023, via AGENAS and regional HTA agencies.
- Maintains national DRG system for inpatient services, but regional agencies have autonomy to direct payment and purchasing decisions.
- Runs a universal public health system, with a limited role for private insurance.
More Resources
- The consultancy MTRC provides a helpful outline on its page, “Market Access for Medical Technologies in Italy.”
- Read more about Italy’s medical device’s market in the International Trade Administration’s
- Read more about the European Medical Device Nomenclature from the European Commission.
