This article was updated June 2, 2025.
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU), which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation. However, there are slight differences in the regulatory requirements that vary between each country within the EU. For example, one difference is the institution responsible for regulating medical devices in each country. In Italy, medical devices are regulated by the Ministry of Health Directorate General for Medicines and Medical Devices using the National Health Information System (NSIS).
The NSIS serves as a comprehensive platform for managing health data, supporting governance, service delivery, and communication objectives at national, regional, and local levels within Italy’s National Health Service (Servizio Sanitario Nazionale, SSN). It facilitates the collection and analysis of data related to medical devices, including information on device usage and associated healthcare services. Additionally, the Italian National Medical Devices Inventory (Repertorio Dispositivi Medici – RDM) maintains records of CE-marked medical devices authorized for use in Italy.
Manufacturers intending to market medical devices in Italy are required to register their products with the Ministry of Health. This process involves submitting detailed information about the device and the manufacturer, ensuring compliance with national regulations. The registration is mandatory for all classes of medical devices and is a prerequisite for placing products on the Italian market. The Ministry provides specific forms and guidelines to facilitate this process, ensuring that all medical devices meet the necessary safety and performance standards before being made available to healthcare providers and patients.
Classification
The European Union’s harmonized standards on medical devices apply to all member states, including Italy. Therefore, all medical devices in Italy are subject to the same classification system as other member states:
- Class I – Devices with low risk, non-invasive.
- Class IIa – Medium-risk devices, including those that are invasive but do not interact with the body in a dangerous manner.
- Class IIb – Medium-high risk devices that interact with the body in a potentially hazardous way.
- Class III – High-risk medical devices, including implantable devices and those interacting with vital organs.
These classifications are in accordance with Regulation (EU) 2017/745 on medical devices.
Registration Process in Italy
Under the EU harmonized standards, all medical devices must obtain CE marking before being marketed in the European Union. The CE mark signifies conformity with the current EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), allowing the device to be marketed throughout the EU, regardless of the country of registration.
In Italy, manufacturers must register their medical devices with the Ministry of Health’s national database, known as the Banca Dati dei Dispositivi Medici (BD/RDM). This registration process is mandatory for all classes of medical devices.Ministry of HealthWikipedia
Manufacturers are also encouraged to implement a Quality Management System (QMS). One of the most recognized standards is the ISO 13485 certification, which is valid for three years.
The duration of the registration process varies depending on the class of the device. Class I devices, being low risk, typically have a quicker registration process. In contrast, Class III devices, due to their high risk, may require several months for registration. This timeframe can also vary based on the specific requirements of each EU member state’s regulatory authority.
Market overview
Italy remains a mature and significant market for medical devices, ranking as the fourth largest in Europe after Germany, France, and the United Kingdom. The Italian medical device sector encompasses approximately 4,500 companies, including 42% distributors, 53% producers, and 5% service providers, employing over 118,000 individuals. As of 2021, the market was valued at $11.8 billion, with imports accounting for $7.8 billion. Public hospitals are the primary purchasers, accounting for over 75% of medical device acquisitions, while the private sector accounts for the remaining 25%. Despite a robust local manufacturing industry, Italy’s medical device market is heavily reliant 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%).
The highest demand for medical equipment in Italy includes areas such as high-frequency medical lasers, home care equipment, remote monitoring equipment, anesthesiology equipment, and stimulators and defibrillators. The Italian government’s emphasis on value-based healthcare is driving demand for innovative products that offer better health outcomes in cost-effective ways. This shift is creating opportunities for companies with advanced technologies, particularly in preventive care, remote monitoring, and early identification of at-risk patients.
Medical device regulations: https://www.regdesk.co
