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

Abstract

Objectives: This study investigates the benefits, limitations and awareness of using Real World Evidence and Real World Data for post-market clinical follow-up studies and clinical evaluation reports in the European Medical Device Regulations.

Methodology: A mixed methods study was utilized with qualitative interviews and a quantitative survey.

Results: The findings from the study demonstrate that in the case of the Medical Device Regulations, opportunities exist for manufacturers of legacy devices to conduct Real World Evidence studies to bridge gaps in clinical evidence. The primary value of Real World Evidence lies in its ability to provide an accurate and, therefore, more reliable measure of device safety and performance. As a measure of safety and performance, it supplements clinical evidence generated from pre and post-market clinical investigations, reducing the costs associated with these studies and supporting the manufacturer's benefit: risk conclusion.

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.