As part of its work, CORE–MD reviewed methods for evaluating high-risk medical devices, in order to translate expert evidence into advice for EU regulators and to recommend an appropriate balance between innovation, safety, and clinical effectiveness.
“It’s very important that regulatory institutes know exactly how to evaluate implants and the CORE-MD project tried by this to improve the quality of the evidence of the implants being evaluated for the European market foreign” says Prof. Per Kjaersgaard-Andersen from EFORT & the University of Southern Denmark.
Key findings from CORE-MD partners 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 High Risk Medical Devices (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.
For more information, visit the Work Package 1 section of our website.
