Italy has implemented a significant update to its pharmaceutical regulations with a new decree aligning with the EU's Falsified Medicines Directive (FMD). This decree mandates the use of a 2D Data Matrix barcode on the secondary packaging of pharmaceutical products, with the exception of those exempt under Annex I of EU Regulation 2016/161. The barcode must adhere to GS1 standards and encode specific information, including the Global Trade Item Number (GTIN), serial number, batch number, expiration date, and the unique 9-digit identifier assigned by the Italian Medicines Agency (AIC code).

This move necessitates operational changes for pharmaceutical manufacturers, including updates to packaging lines to support the printing and verification of these barcodes, and ensuring IT systems can manage and report the serialized data in real-time to national and EU repositories. The decree aims to enhance supply chain visibility, reduce the risk of counterfeit medicines, and improve the efficiency of product recalls. While the decree is already in effect, a transition period until February 8, 2027, allows companies to either continue with Italy's existing "Bollino Farmaceutico" system or fully adopt the EU FMD serialization model. After this date, full compliance with the EU model will be mandatory, with significant financial penalties for non-compliance.

 Italy's healthcare system is undergoing a significant push towards digitalization in 2025, which will have implications for the integration and use of medical devices. A key development is the ongoing implementation of the National Recovery and Resilience Program (NRRP), which includes substantial investments in e-health infrastructure and the electronic medical record (EMR). By 2022, Italy's spending on ICT in healthcare reached $1.98 billion, and further investments are planned to expand the use of EMRs and telemedicine services.

This increasing focus on digital health solutions creates opportunities for advanced medical devices that can seamlessly integrate with these systems. The government has allocated significant funds (€1.18 billion) within the NRRP for the procurement of modern medical equipment, including diagnostic imaging devices and health IT platforms for general practitioners. Furthermore, €1 billion is earmarked for telemedicine to enhance local healthcare assistance. These investments signal a growing demand for digitally enabled medical devices that can contribute to a more connected and efficient healthcare ecosystem in Italy.

Italy has updated its regulations concerning the advertising of medical devices to align with the EU Medical Devices Regulation (MDR). While the MDR aims for a uniform regulatory framework across the EU, Italy has maintained certain national requirements. New decrees issued by the Ministry of Health in 2023 outline which medical devices can be advertised without prior authorization and provide guidelines for advertising messages.

Generally, advertising for custom-made medical devices, devices requiring a medical prescription or the assistance of a healthcare professional, and devices that can only be sold with a prescription remains prohibited to the general public. However, the advertising of certain accessories and general product information without specific health claims may be permissible without prior authorization. Online dissemination of product images, descriptions, and instructions for use is also generally allowed without authorization. These regulations aim to balance the need for transparency and accurate information with the protection of public health.

General Information on Italy's Medical Device Industry

Italy represents a significant market for medical devices, being the seventh-largest in Europe. The market is characterized by a mix of domestic manufacturers, primarily small and medium-sized enterprises (SMEs), and a strong presence of international players through imports. The northern regions of Lombardy, Veneto, and Emilia Romagna host the highest concentration of medical device companies.

Key Aspects of the Italian Medical Device Market:

• Public Healthcare Dominance: Public hospitals account for a substantial portion (over 75%) of medical device purchases in Italy.

• Import Reliance: Italy imports a significant amount of its medical devices, with the United States being a key supplier. Major import categories include diagnostic imaging, dental equipment, and patient aids.

• Shift Towards Value-Based Healthcare: Due to budgetary pressures, the Italian healthcare system is increasingly focusing on value-based healthcare, favoring cost-effective products that offer better patient outcomes.

• Investment in E-health: As highlighted in the news, Italy is making considerable investments in e-health infrastructure and telemedicine, creating opportunities for digitally integrated medical devices.

• Regulatory Landscape: All medical devices marketed in Italy must bear the CE mark. While aligning with EU regulations, Italy also has its own registration requirements with the Ministry of Health.

• Procurement System: The Italian healthcare procurement system is decentralized, with numerous regional procurement centers in addition to a National Procurement Agency (CONSIP).

The Italian medical device market presents both opportunities and challenges for manufacturers. The aging population and the drive for improved healthcare services contribute to a growing demand for medical technology. However, navigating the decentralized procurement system and adapting to evolving regulations are crucial for success in this market. The increasing focus on digitalization and value-based care will likely shape the future demand for innovative and cost-effective medical device solutions in Italy.