Italy - Country Commercial Guide
Medical Devices and Technology

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-10-28

Overview

Italy is a mature market for medical equipment and the fourth largest in Europe after Germany, France, and the U.K. with about 4,323 companies (including 42% distributors, 53% producers, and 5% service providers) and a workforce of 94,153. The medical device market (including dental and optical devices) was valued at approximately $10.2 billion in 2019 with imports accounting for $6.8 billion. Public hospitals account for over 75% of medical device purchases, while the private sector represents 25%. COVID-19 has negatively affected the growth of the medical devices market in Italy. While there has been a significant increase in demand for personal protective equipment and ventilators, demand in other product categories, especially orthopedic and dental devices, has declined.   

           Unit: USD Millions

 

2018

2019

 

2020

(Estimated)

2021

(Estimated)

Total Local Production

8,828

8,081

7,526

8,777

Total Exports

4,980

4,704

4,450

4,957

Total Imports

6,990

6,866

6,670

6,890

Imports from the US

388

392

380

395

Total Market Size

10,838

10,243

9,746

10,710

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

Exchange rate 1 USD = EUR 0.81 (2019) 

Despite having a considerable local manufacturing industry, the domestic market for medical equipment is highly dependent on imports. Major suppliers include the Netherlands, Germany, Belgium, France, and the United States. In 2019, the United States was responsible for 5.7% of Italian imports, valued at $392 million. Major U.S. medical device imports include diagnostic imaging, dental and patient aids. A significant number of U.S. manufacturers of medical equipment 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, sterilizers, hospital furniture, anesthesia equipment, dialysis equipment, and dental products ranging from instruments to dental chairs. The highest concentration of medical devices companies is in Northern Italy, primarily in the regions of Lombardy, Veneto, and Emilia Romagna, which is an important hub for major medical device companies.

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 very 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 practitioners’ use include ECG, spirometers, halters, dermo scopes, 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 spent on the purchase of 3,133 devices including CT scans, MRIs, linear accelerators, fixed X-ray systems, angiographs, gamma cameras, PET CT scans, mammographs, and ultrasound devices. Procurement is expected to occur at the end of 2024.  Additionally, plans call for investment of €1.45 billion in 280 hospitals to advance digitalization, including applications in surgery units, LISS, laboratory information systems, pharmacy services, emergency rooms, triage, drug prescriptions, diagnostics, repository, and scheduling.

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

E-Health

COVID-19 has demonstrated the need for e-health solutions to improve the Italian healthcare system. The information technology applied to the healthcare systems is a key enabler for delivering more effective and efficient healthcare. In 2019 in Italy, Information Communication Technology (ICT) expenditures in healthcare was $1.8 billion, corresponding to 1.2% of total healthcare expenditures.  This percentage is less than the level in other developed countries, where the average is around 2.5-3%. Despite the 5% increase with respect to 2018, expenditures for the adoption of digital instruments in healthcare remain fragmented.

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 activated in 21 regions but is only used by 12% of the population. Another €1 billion will be invested in telemedicine to enhance healthcare assistance at the local level by allowing patients to stay 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.

On May 26, 2021, new EU regulations on medical devices went into effect, while regulations on in vitro diagnostic medical devices will go into effect on May 26, 2022.  These regulations will replace the existing three Directives: Active Implantable Medical Devices Directive (90/385/EEC), Medical Devices 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. For more information on the regulations, please visit: https://ec.europa.eu/health/md_sector/overview_en  

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.  The online registration can be found on the Ministry of Health’s website:

https://www.salute.gov.it/portale/home.html

 

U.S. Commercial Service Contact:

Kira Migliorini, Healthcare Specialist

U.S. Commercial Service, U.S. Embassy Rome

Tel: +39 064674 2202

E-mail:Kira.Migliorini@trade.gov