The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study

CONCLUSION: This study provides insight into how the medical device industry could utilize Real World Evidence and have an initiative in the EU similar to the FDA-sponsored NESTcc partnership. This would aid medical device manufacturers in transitioning to the MDR clinical evaluation requirements and mitigate the impact on medical device availability in the EU.PMID:38041629 | DOI:10.1080/17434440.2023.2291454

Source: Expert Review of Medical Devices - December 2, 2023 Category: Medical Devices Authors: Olivia McDermott Breda Kearney Source Type: research