With the enforcement of the European Medical Devices Regulation (MDR), clinical evidence has become a cornerstone for regulatory compliance, as highlighted by Pietro Calamea, Director of Office VI – Clinical Investigation of Medical Devices, Directorate General of Medical Devices and Pharmaceutical Services, Ministry of Health, during the AboutMedicalDevices conference. However, contrary to expectations, there has not been a significant increase in clinical investigations. A more marked growth is observed in post-market investigations, while pre-market investigations remain less prevalent.
Dichotomy Between Large Companies and SMEs
An analysis of manufacturers’ behavior reveals a clear division based on company size:
- Large International Companies:
These established manufacturers continue to conduct multicentre clinical investigations globally, including in Italy. This approach reflects a greater awareness of the importance of generating rigorous, detailed, and comprehensive clinical data, necessary to demonstrate the safety and performance of devices. - Small and Medium Enterprises (SMEs):
For SMEs, often at the forefront of developing emerging technologies such as AI-based software and robotics, the approach to clinical investigations is less structured. This shortfall is compounded by:- Limited awareness of the importance of clinical evidence.
- Inexperience in designing and producing medical devices, further complicating compliance with regulatory requirements.
Role of Clinical and Academic Research
In the field of emerging technologies, SMEs are supported by clinical and academic research, which plays a crucial role in developing new solutions. However, without adequate planning and increased awareness of regulations, SMEs risk not fully leveraging the opportunities provided by the new regulation.
Future Outlook
As the 2028 deadline approaches, it is essential for SMEs to adopt a more structured approach to clinical investigations. Investing in training, collaboration with academic institutions, and strategic planning could enable them to compete effectively in the regulated market, contributing to technological progress and patient safety.
Aglatech14 ContenTalkers
Laura Legnani – Marketing Services Manager
