Background: The European Medical Devices Regulation (MDR) 2017/745 seeks to minimize clinical uncertainty – especially regarding the generation, dissemination, and quality of clinical evidence – across all phases of the medical device lifecycle: pre-market, market approval, post-market, and disinvestment. Although the MDR promotes using gold-standard methodologies, such as Randomized Controlled Trials to address clinical uncertainty, healthcare organizations face significant challenges in applying these methods. These challenges affect the effectiveness of evidence generation, dissemination, and quality. As a result, healthcare systems must incorporate technological, organizational, and managerial tools to manage these difficulties throughout the medical device lifecycle. This study aims to identify the tools that can reduce clinical uncertainty associated with medical devices.
Methods: The research adopts a case study approach, focusing on the Tuscany Regional Healthcare System, which is recognized nationally for its effectiveness, efficiency, and appropriate care delivery.
Results: The findings indicate that the majority of the identified tools are concentrated in the pre-market and post-market stages. Examples include study coordinators (organizational tools), standardized templates (technological tools), and case report forms (managerial tools), all of which improve the quality of clinical evidence. In addition, tools such as patient diaries (managerial) and surgical trainers (organizational) play a crucial role in enhancing both the generation and dissemination of evidence during these phases.
Discussion and Implications: This research provides useful insights for policymakers in guiding healthcare organizations on how to implement the MDR effectively. A key takeaway is the importance of introducing clinical registries, surveillance systems, and data collection platforms to gather real-world evidence, which are essential in the post-market phase. The study contributes to the ongoing discourse surrounding medical devices’ clinical uncertainty by identifying technological, organizational, and managerial tools that can strengthen clinical evidence for medical devices.