The medical device sector in Italy is facing more complex challenges than other European countries. Despite a market valued at €12.4 billion—split 75% in public healthcare and 25% in private healthcare—and a 6.9% growth rate, 2022 saw a 30% drop in research and development investments. It remains unclear whether this situation is temporary or structural, but it is evident that the global industry’s focus is shifting toward the U.S. market at the expense of Europe, driven by the impact of the MDR regulation for medical devices.
This warning was raised by Luigi Mazzei, Vice President of Confindustria Dispositivi Medici, during the About Medical Devices conference organized by AboutPharma and Airmedd on November 26 in Milan, which addressed critical issues for the future of the medical device sector.
The MDR Regulation for Medical Devices Impacts on European Competitiveness
Europe was once the global leader in innovation for medical devices, with European physicians exporting their expertise across the Atlantic to the United States. Today, the paradigm has reversed: Europe has become the last geographic area where medical devices are launched. In contrast, the U.S., with a strategy that combines industrial development and patient-centered care, has adopted a more flexible and collaborative regulatory approach, facilitating the market introduction of innovations.
Europe, on the other hand, seems to have lost its comprehensive vision. The MDR regulation, the HPA framework, and national issues related to funding and procurement fragment the process, rendering it inefficient. This fragmentation risks delaying the introduction of innovative technologies to patients, with an unfavourable balance between potential benefits and risks to public health.
A Holistic Approach to Regain Competitiveness
The Vice President emphasized the urgency of adopting a holistic approach that considers the entire process: from research and development to clinical evaluation, regulation, procurement, and surveillance. A harmonized European governance involving notified bodies, the European Commission, and the industry is essential to ensure smooth and consistent dialogue among all stakeholders.
Solutions do exist, and some are already being tested. Acceleration pathways and funds dedicated to national innovation could facilitate technology transfer to patients. Furthermore, interim solutions will be necessary to avoid significant shortages of products that need to be recertified by December 31, 2028 (the deadline for low- and medium-risk medical device manufacturers to complete the certification of their products to remain on the European market).
The message is clear: existing solutions must be implemented, fragmentation must be overcome, and Europe must reclaim its position as a global leader in medical device innovation.
Aglatech14 ContenTalkers
Laura Legnani – Marketing Services Manager
