Find stats on top websites
Industry Landscape
The Italian medical device market is robust, driven by an aging population and increasing demand for specialized procedures. It's characterized by strong regulatory oversight and a preference for high-quality, innovative products. Distributors like Kaster play a crucial role in bridging international manufacturers with local healthcare providers.
Total Assets Under Management (AUM)
Medical Devices Market Size in Italy
~Approximately 17 billion EUR (2022)
(5.7% (2023) CAGR)
- Driven by increasing healthcare expenditure.
- Innovations in medical technology.
- Growing elderly population.
Total Addressable Market
17 billion EUR
Market Growth Stage
Pace of Market Growth
Emerging Technologies
AI-powered Diagnostics & Surgical Robotics
AI integration in medical devices for enhanced diagnostic accuracy and robotic assistance in surgery for precision and efficiency.
3D Printing of Medical Devices
Additive manufacturing techniques allowing for the creation of customized implants, prosthetics, and surgical models directly at the point of care.
Remote Patient Monitoring (RPM) & Telemedicine Devices
Wearable sensors and connected devices for continuous patient data collection and virtual healthcare delivery, expanding care beyond traditional settings.
Impactful Policy Frameworks
EU Medical Device Regulation (MDR) 2017/745 (fully applicable since May 26, 2021)
The MDR significantly strengthens pre-market and post-market requirements for medical devices, focusing on clinical evidence, traceability, and post-market surveillance throughout the product lifecycle.
This regulation requires Kaster to ensure all imported and distributed devices comply with stricter conformity assessment procedures, leading to potential delays for new product introduction and increased compliance costs for manufacturers they represent.
Italian Law 24/2017 (Gelli-Bianco Law) on Professional Liability in Healthcare
This law, effective from April 1, 2017, clarifies the liability of healthcare professionals and structures, emphasizing patient safety and quality of care, with implications for medical device use and traceability.
The law increases the emphasis on product quality and safety from Kaster's perspective, as device failures could lead to liability claims for healthcare providers, reinforcing the need for their rigorous quality assurance and technical support.
National Health Plan (Piano Sanitario Nazionale - PSN) 2023-2025 (Italy)
While a broad strategic document, the PSN outlines priorities for the Italian National Health Service, including technological innovation, digital health transformation, and strengthening territorial healthcare, which influences procurement and investment in medical devices.
The PSN will likely drive demand for Kaster's specialized medical devices that align with the national strategic priorities, especially those supporting digitalization and regional healthcare networks, potentially influencing procurement budgets and tender specifications.
Transform Your Ideas into Action in Minutes with WaxWing
Sign up now and unleash the power of AI for your business growth
