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

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI:10.1080/17434440.2023.2291454
Olivia McDermott, Breda Kearney
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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.

在欧洲医疗器械法规中使用真实世界证据作为临床证据来源的价值:一项混合方法研究。
目的:本研究调查了欧洲医疗器械法规在上市后临床随访研究和临床评估报告中使用真实世界证据和真实世界数据的益处、局限性和意识。研究方法:采用定性访谈和定量调查相结合的方法进行研究。结果:研究结果表明,在医疗器械法规的情况下,遗留设备制造商有机会进行真实世界证据研究,以弥合临床证据的差距。真实世界证据的主要价值在于它能够提供准确的,因此更可靠的设备安全性和性能测量。作为安全性和性能的衡量标准,它补充了上市前和上市后临床调查产生的临床证据,降低了与这些研究相关的成本,并支持了制造商的获益风险结论。结论:这项研究为医疗器械行业如何利用真实世界的证据提供了见解,并在欧盟有一个类似于fda赞助的NESTcc伙伴关系的倡议。这将有助于医疗器械制造商过渡到MDR临床评估要求,并减轻对欧盟医疗器械可用性的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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