Post-market surveillance of medical devices using real-world data: a scoping review and Brazilian regulatory data analysis

Real-world data (RWD) and real-world evidence (RWE) are increasingly used to strengthen post-market surveillance of medical devices (MDs) by complementing the limitations of pre-market investigations in detecting rare adverse events, long-term device performance, and real-world clinical outcomes. This study comprised two complementary components. First, a scoping review following the PRISMA-ScR guidelines was conducted to map the applications of RWD and RWE in the post-market surveillance of medical devices. Second, a descriptive analysis of adverse event notifications recorded in the Brazilian Health Surveillance Notification System (Notivisa) between January 2024 and June 2025 was performed to contextualize the international evidence within the Brazilian regulatory setting. The scoping review identified 332 eligible studies, with a focused descriptive synthesis of 114 publications from 2021 to 2025. The included studies were organized into four analytical domains representing the principal applications of RWD/RWE in post-market surveillance. Safety surveillance and clinical effectiveness predominated, particularly for higher-risk devices, whereas economic, organizational, and patient-centered outcomes were comparatively underrepresented. The complementary analysis of 34,048 Notivisa notifications demonstrated that most reports involved technical complaints and non-fatal adverse events, whereas fatal outcomes were concentrated among implantable and life-support devices classified as Class III and IV, consistent with the international evidence. The findings demonstrate that RWD and RWE are becoming strategic components of lifecycle-based post-market surveillance, supporting risk-proportionate regulatory decision-making. The integration of international evidence with national technovigilance data reinforces the need for interoperable surveillance systems, active monitoring strategies, and standardized analytical approaches to strengthen evidence-based regulation of medical devices. Not applicable. Open Science Framework (OSF), osf.io/mfq6h; DOI: https://doi.org/10.17605/OSF.IO/B2ZU8 .