医疗器械法规（MDR）在医疗技术企业中的应用——管理者和监管专业人员的观点。
Medical device regulation (MDR) in health technology enterprises - perspectives of managers and regulatory professionals.
机构信息
Department of Health and Social Management, University of Eastern Finland, Yliopistonranta 1, Kuopio, 70210, Finland.
出版信息
BMC Health Serv Res. 2023 Mar 30;23(1):310. doi: 10.1186/s12913-023-09316-8.
BACKGROUND
In the European Union (EU), there are over half a million medical devices, varying from pacemakers to software. Medical devices play an important role in health care as they are used in diagnosis, prevention, monitoring, prediction, prognosis, treatment, or to alleviate disease. Medical devices are regulated in the EU by the Medical Device Regulation (MDR), which came into force on 25 April 2017 and into application on 26 May 2021. The demand for regulation arose from the need to establish a transparent, robust, predictable, and sustainable regulatory framework. This study aims to examine how the managers and regulatory professionals in health technology enterprises perceived the application of the MDR and what were their information needs regarding the MDR.
METHODS
A link to an online questionnaire was sent to 405 managers and regulatory professionals representing health technology enterprises in Finland. The study included 74 respondents. Descriptive statistics were used to describe and summarise the characteristics of the dataset.
RESULTS
Information related to the MDR was fragmented and the necessary information was sought from multiple information sources, while the Finnish Medicines Agency (Fimea) was regarded as the most important source of information and training provider. To some extent, the managers and regulatory professionals expressed their dissatisfaction with the performance of Fimea. The managers and regulatory professionals were not very familiar with the ICT systems provided by the EU. The size of an enterprise affected how many medical devices it manufactures and generally affected the views about the MDR.
CONCLUSIONS
The managers and regulatory professionals understood the role of the MDR regarding the safety and transparency of medical devices. The available information regarding the MDR did not properly fit the needs of users and there seemed to be a gap in information quality. The managers and regulatory professionals had some difficulties understanding the available information. Based on our findings, we believe it is paramount to evaluate the challenges faced by Fimea and how it could improve its performance. To some extent, the MDR is regarded as a burden for smaller enterprises. It is important to highlight the benefits of ICT systems and to develop them to better meet the information needs of enterprises.
背景
在欧盟（EU），有超过 50 万种医疗器械，从心脏起搏器到软件不一而足。医疗器械在医疗保健中发挥着重要作用，因为它们可用于诊断、预防、监测、预测、预后、治疗或减轻疾病。欧盟通过《医疗器械法规》（MDR）对医疗器械进行监管，该法规于 2017 年 4 月 25 日生效，并于 2021 年 5 月 26 日实施。监管需求源于建立透明、稳健、可预测和可持续监管框架的需要。本研究旨在调查医疗技术企业的管理人员和监管专业人员如何看待 MDR 的应用，以及他们对 MDR 的信息需求是什么。
方法
向代表芬兰医疗技术企业的 405 名管理人员和监管专业人员发送了一份在线问卷链接。该研究共包括 74 名受访者。采用描述性统计方法对数据集的特征进行描述和总结。
结果
与 MDR 相关的信息是零散的，必要的信息是从多个信息来源中寻找的，而芬兰药品管理局（Fimea）被视为最重要的信息来源和培训提供者。在一定程度上，管理人员和监管专业人员对 Fimea 的表现表示不满。管理人员和监管专业人员对欧盟提供的信息和通信技术系统并不熟悉。企业的规模影响其生产的医疗器械数量，通常也会影响对 MDR 的看法。
结论
管理人员和监管专业人员理解 MDR 在医疗器械安全性和透明度方面的作用。关于 MDR 的可用信息不能很好地满足用户的需求，信息质量似乎存在差距。管理人员和监管专业人员在理解可用信息方面有些困难。基于我们的研究结果，我们认为评估 Fimea 面临的挑战以及它如何提高其绩效至关重要。在一定程度上，MDR 被视为小型企业的负担。重要的是要强调信息和通信技术系统的好处，并开发这些系统以更好地满足企业的信息需求。
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