Overview

Italy is a mature market for medical equipment and the fourth largest market in Europe after Germany, France, and the UK, with about 4,500 companies (42% distributors, 53% producers, and 5% service providers) and over 118,000 employees. The medical device market (including dental and optical devices) was valued at $11.8 billion in 2021 with imports accounting for $7.8 billion. Public hospitals account for over 75% of medical device purchases, and the private sector 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.

           Unit: USD Millions

The above statistics are unofficial estimates based on reports from Fitch Solutions and Assobiomedica,

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 (28.2%), Germany (21.4%), Belgium (11.7%), France (8.1%), China (5.9%), and the United States (5.3%). In 2021, the United States’ share of Italian imports was valued at $415 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

At the beginning of 2020, the Italian government, hoping to improve local healthcare assistance to patients and reduce emergency room dependency, allocated €235 million for the acquisition of basic diagnostics devices. Such devices for general-practitioner use include ECG machines, spirometers, halters, dermoscopes, ultrasound devices (EcoFAST), as well as health IT platforms.

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 will 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 was underway in 2023. 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 2022 expenditures in information communications and technology (ICT) in healthcare were $1.98 billion, 7% more than in 2021, corresponding to 1.2% of total healthcare expenditures. This percentage is less than that in other developed countries, where the average is 2.5%–3%.

Another NRRP-related healthcare priority is investment in e-health technology infrastructure and the electronic medical record (EMR), for which the government has allocated €1.67 billion. Currently, the EMR is active in 21 regions and used by 35% of the population. Another €1 billion will be invested in telemedicine to enhance healthcare assistance at the local level.

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.

New 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 new regulations, the MDR transition period was extended in March 2023 from May 2024 till 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:

Resources

Ministry of Health

National Procurement Agency (CONSIP)

Exposanita (April 17-19, 2024) 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