Italy Country Commercial Guide
Learn about the market conditions, opportunities, regulations, and business conditions in italy, prepared by at U.S. Embassies worldwide by Commerce Department, State Department and other U.S. agencies’ professionals
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Medical Devices and Technology
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Overview

Italy is a mature market for medical equipment and the fourth largest market in Europe after Germany, France, and the UK, with about 4,640 companies (32% distributors, 59% producers, and 7.7% service providers) and more than 117,000 employees. The medical device market (including dental and optical devices) was valued at $13. billion in 2024 with imports accounting for $9 billion. Public hospitals account for more than 75% of medical device purchases, and the private sector for 25%. Market growth will be constrained by the economic slowdown and by cost containment measures, such as “payback,” whereby companies are required to cover government spending that exceeds budget ceilings.

          Table: Total Market Size of Medical Equipment. Unit: USD Millions 

 2021 2022 2023 2024  
Total local production 11,028 11,654 10,111 10,337 
Total exports 5,400 5,200 6,000 6,300 
Total imports 7,800 7,300 8,800 9,000 
Imports from the United States 415 356 363 359 
Total Market Size 13,428 13,754 12,911 13,037 

The above statistics are unofficial estimates based on reports from Fitch Solutions and Confindustria Dispositivi Medici  
Exchange rate 1 USD = EUR 1.1 (2023)  

Despite a considerable local manufacturing industry, the domestic market for medical equipment in Italy is highly dependent on imports. Major suppliers include the Netherlands (32.6%), Germany (18.2%), Belgium (11.3%), France (8.7%), China (5%), and the United States (4%). In 2024, the United States’ share of Italian imports was valued at $359 million. Major U.S. medical device imports include those for diagnostic imaging and dental use, and patient aids. Many U.S. medical equipment manufacturers are present in the Italian healthcare market.

The manufacturing sector in Italy is made up of a broad network of small and micro businesses and start-ups. Local manufacturers are strong in producing diagnostic-imaging equipment, contrast media for imaging, orthopedics and prosthetics, biomedical instruments and electro medical diagnostics, dialysis equipment, and dental products ranging from instruments to dental chairs. The highest concentration of medical-device companies is in northern Italy, primarily in the regions of Lombardy, Veneto, and Emilia Romagna.

Budgetary pressures and escalating costs are moving Italy towards value-based health care: new products that provide better health outcomes in cost-effective ways. The public healthcare system is likely to develop value-based and quality-based pricing models and request data and analytics to assess cost-effectiveness. Opportunities for companies with innovative products are increasing compared to those marketing traditional products. Demand for preventive care, remote monitoring, and early identification of at-risk patients is also increasing.  

Leading Sub-Sectors and Opportunities

Medical Devices

Within the National Recovery and Resilience Program (NRRP), the healthcare sector is slated to receive €1.18 billion to replace obsolete medical equipment. The money must be used to purchase 3,133 devices, including CT scanners, MRI machines, linear accelerators, fixed x-ray systems, angiography systems, gamma cameras, PET scanners, mammography units, and ultrasound devices. Procurement is 90% completed. In addition, plans call for the investment of €1.45 billion in 280 hospitals to advance digitalization, including applications in surgery units, less-invasive stabilization systems (LISS), laboratory information systems, pharmacy services, emergency rooms, triage, drug prescriptions, diagnostics, repositories, and scheduling.  

The Italian market is receptive to high-quality and technologically advanced diagnostics as well as therapeutic equipment and products.  

E-Health

The COVID-19 pandemic demonstrated the need for e-health solutions in the Italian healthcare system. Information technology applied to the healthcare system is a key enabler for delivering more effective and efficient healthcare. Italy’s 2024 investments in information communications and technology (ICT) in healthcare peaked at $2.89 billion, up 12% from 2023 These funds come partly from the resources of the National Recovery and Resilience Plan (PNRR), which allocates more than 45% of its healthcare funds to digitalization.

Primary investment areas include Electronic Health Record, Telemedicine, and Cybersecurity and Cloud Computing. Currently, the use of Electronic Medical Records (EMR) is active in all regions of Italy and used by 95% of doctors.  To enable telemedicine services, the Ministry of Health, through its agency AGENAS, launched a National Telemedicine Platform (https://pnt.agenas.it/home).  

Requirements  

The Italian healthcare procurement system is organized into 33 procurement centers and a National Procurement Agency. Most purchases are made by public tender and are open to both domestic and foreign companies. Announcements of tenders on public procurements are available on the website of the National Procurement Agency, CONSIP. It is unrealistic for a foreign firm to assume it can navigate the cumbersome bureaucratic procedure of public procurement without having a base in Italy or a strategic Italian partner.  

EU regulations on medical devices (MDR) on in-vitro diagnostic medical devices went into effect on May 26, 2001, and May 26, 2022, respectively. Due to delays in approving notified bodies and managing the regulations, in March 2023 the MDR transition period was extended from May 2024 until the end of 2027 or the end of 2028, depending on the risk class of the device. These regulations replace three existing directives: Active Implantable Medical Device Directive (90/385/EEC), Medical Device Directive (93/42/EEC), and In-Vitro Diagnostic Medical Device Directive (98/79/EEC).

All medical devices marketed in the EU must bear the CE mark. More information on the regulations can be found on the European Commission website. New medical devices must be registered by the Directorate General of Medical Devices and Pharmaceutical Services at the Italian Ministry of Health and have a unique identification number in the National Health System directory (Repertorio). We recommend U.S. companies designate a third party in Italy to register their products with the Ministry of Health. Online registration can be found on the Ministry of Health’s website (see below).

Resources

Ministry of Health
National Procurement Agency (CONSIP)
Exposanita (April 12-24, 2026) Bologna, Italy

U.S. Commercial Service Italy:
Kira Migliorini, Healthcare Specialist
U.S. Commercial Service, U.S. Embassy Rome
Tel: +39 06 4674 2204
E-mail: kira.migliorini@trade.gov

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