Approval of medical devices in Italy - A guide for manufacturers
The approval of medical devices in Italy is based on the European Medical Device Regulation (MDR 2017/745) and the national requirements of the Italian Ministry of Health (Ministero della Salute). In addition to CE marking, registration in the Italian medical device database (NSIS) is mandatory before products can be launched on the market.
This guide provides a detailed overview of the requirements for market access in Italy.
General overview of the medical device market in Italy
Population size
Italy has a population of around 60 million people, making it one of the largest healthcare markets in Europe.
Market volume
- The Italian medical technology market is estimated to be worth around 16.5 billion euros.
- Around 60 percent of medical technology products sold in Italy are imported.
- With an import share of 25 percent, Germany is the most important trading partner for medical technology products.
Forecasts for the next three years
- The industry is growing at a forecast annual growth rate (CAGR) of 4 to 6 percent.
Key growth drivers are the modernization of the healthcare system, investments in digitalization and the ageing population.
Competent authority for medical devices in Italy
Medical devices are monitored by the Ministero della Salute, in particular by the Direzione generale dei dispositivi medici, del servizio farmaceutico e della sicurezza delle cure.
Tasks of the authority
- Management of the NSIS database
- Implementation of the EU Medical Device Regulation (MDR 2017/745) into national law
- Market surveillance and conformity control of medical devices
- Regulation of advertising for medical devices
Obligation to register in Italy
Manufacturers must enter their medical devices in the national medical device database (NSIS) before placing them on the market.
Registration process in the NSIS database
- Creation of a user account in the NSIS system
- Entry of the manufacturer or authorized representative in the system
- Input of device data, including CE certificate and technical information
- Checking and correcting incorrect entries
- Electronic signature and submission of registration
The processing time is usually 30 to 45 days.
Need for a local representative
Non-EU manufacturers must appoint an Authorized Representative (AR).
- The AR must be based in the EU.
- It takes over the registration in the NSIS database.
- He acts as the main point of contact for the Italian authorities.
Language requirements
- All registration documents must be in Italian.
- Instructions for use, labels and packaging must be fully translated into Italian.
Special features of the registration
- There are no direct fees for registration in the NSIS database.
- Additional administrative fees may be incurred if external service providers are used for registration.
- The CE marking is valid for five years.
Support from MEDAGENT
MEDAGENT offers comprehensive services for the Italian market:
- Assuming the role of Authorized Representative (AR)
- Registration in the NSIS database
- Advice on CE marking and technical documentation
- Support for post-market surveillance and vigilance
For further information or assistance with the approval of medical devices in Italy, please contact us directly.
