This article highlights the similarities and differences in the acceptance of real-world evidence (RWE) as clinical data for medical devices in the US and the EU. It will explore the industry perspective on the use of RWE in the US and the notified body perspective on accepting RWE as clinical evidence. The article includes four anonymized case studies in which RWE collected by postmarket clinical follow-up (PMCF) activities was accepted by a notified body in support of CE marking.
