This video presents the work undertaken by CORE-MD partners to strengthen clinical evidence for high-risk medical devices (HRMD). The partners surveyed the landscape of studies available for HRMD that already received CE marking. Key findings indicate that the majority of trials are non-randomized trials and the size of the studies were quite small with a short duration of follow-up.
Additionally, CORE-MD partners investigated on exploring the use of real-world data to generate further evidence for HRMD. In this sense, registries may provide useful information together with the analysis of adverse events. In the context of the implementation of the medical device regulation, improving transparency and robustness of clinical evidence is key to have safe device on the market.
Ultimately, regulators and notified bodies will benefit from improved clinical evidence for the evaluation of HRMD.
