A systematic literature review of real-world evidence (RWE) on post-market assessment of medical devices

The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market medical devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to (i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; (ii) draw policy recommendations for governments and health organisations and identify a research agenda for scholars. A systematic review was undertaken until February 2024 following the PRISMA guidelines. Original peer-reviewed articles in English and incorporating RWE/RWD into any sort of post-market assessment strategy for an MD were included and their reference lists manually checked. A narrative synthesis was employed to describe evidence retrieved. Totally, 145 research articles were identified. Administrative databases were mostly utilised; clinical and/or economic evidence gathered in a short/medium time horizon the most frequently reported; other evidence types (e.g., organisational) underreported; patient perspectives rarely incorporated; the innovation complexity of MDs relatively low. To our knowledge, this study is the first in its kind to provide a comprehensive picture of how non-randomised evidence has been used when assessing MDs working in real-life conditions. The implications of this review might help health policy scholars in addressing the avenues for research in RWE for MDs and policy-makers to better understand the risks and benefits of medium and long-term use of MDs alongside clinical practice and make more informed decisions about adoption and use.