A Modular Approach to Combine Postmarket Clinical Follow-Up Studies and Postmarket Surveillance Studies.

IF 1.3 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Methods of Information in Medicine Pub Date : 2021-09-01 Epub Date: 2021-08-27 DOI:10.1055/s-0041-1735165
Andreas Ziegler, Kristin Forßmann, Sabine Konopka, Katja Krockenberger
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引用次数: 0

Abstract

Background: The European Medical Device Regulation 2017/745 (MDR) has its date of application in May 2021. This new legislation has refined and expanded the need of manufacturers to have a postmarket surveillance (PMS) system. According to this legislation, a postmarket clinical follow-up (PMCF) plan is also required. Manufacturers of high-risk medical devices are obliged to conduct both PMCF and PMS studies. There is thus the need to generate evidence from clinical data.

Objectives: The conduct of several studies for PMS and PMCF can be cumbersome. We therefore aim to present a modular approach to combine PMS and PMCF studies into a single study.

Materials and methods: We extracted the topics listed in the MDR, especially Annex XV, Section 3, the Good Clinical Practice for medical devices (EN 14155:2020, Annex A). In addition, we added topics according to the SPIRIT and the SPIRIT-PRO statement and created a draft clinical investigation plan (CIP).

Results: The CIP template is provided as part of the manuscript. The modular concept has passed the required regulatory and legal requirements for one specific study.

Conclusion: A modular approach for combining PMCF and PMS studies in a single CIP has been developed and implemented, and it is ready for use. The provided CIP template should enable other researchers and groups to adopt this concept according to their needs.

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结合上市后临床随访研究和上市后监测研究的模块化方法。
背景:欧洲医疗器械法规2017/745 (MDR)的申请日期为2021年5月。这项新立法完善并扩大了制造商对上市后监督(PMS)系统的需求。根据这项立法,上市后临床随访(PMCF)计划也是必需的。高风险医疗器械制造商有义务进行PMCF和PMS研究。因此,有必要从临床数据中产生证据。目的:对经前症候群和PMCF进行一些研究可能会很麻烦。因此,我们的目标是提出一种模块化的方法,将PMS和PMCF研究合并为一项研究。材料和方法:我们提取了MDR中列出的主题,特别是附件XV,第3节,医疗器械良好临床规范(EN 14155:2020,附件A)。此外,我们根据SPIRIT和SPIRIT- pro声明添加了主题,并创建了临床调查计划草案(CIP)。结果:CIP模板作为稿件的一部分提供。模块化概念已经通过了一项特定研究所需的监管和法律要求。结论:一个模块化的方法,结合PMCF和PMS的研究在一个单一的CIP已经开发和实施,并准备使用。所提供的CIP模板应使其他研究人员和团体能够根据他们的需要采用这一概念。
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来源期刊
Methods of Information in Medicine
Methods of Information in Medicine 医学-计算机:信息系统
CiteScore
3.70
自引率
11.80%
发文量
33
审稿时长
6-12 weeks
期刊介绍: Good medicine and good healthcare demand good information. Since the journal''s founding in 1962, Methods of Information in Medicine has stressed the methodology and scientific fundamentals of organizing, representing and analyzing data, information and knowledge in biomedicine and health care. Covering publications in the fields of biomedical and health informatics, medical biometry, and epidemiology, the journal publishes original papers, reviews, reports, opinion papers, editorials, and letters to the editor. From time to time, the journal publishes articles on particular focus themes as part of a journal''s issue.
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