A systematic literature review of Real-World Evidence (RWE) on post-market assessment of medical devices

Abstract 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 organizations and identify a research agenda for scholars. A systematic review was undertaken until July 2020 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, 103 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., organizational) 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-randomized evidence has been used when assessing MDs working in real-life conditions. The implications of this review might help 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.