Bianchini Elisabetta, Mayer Christopher Clemens
Institute of Clinical Physiology, Italian National Research Council (CNR), Pisa, Italy.
Center for Health & Bioresources, Medical Signal Analysis, AIT Austrian Institute of Technology GmbH, Vienna, Austria.
Artery Res. 2022;28(2):55-60. doi: 10.1007/s44200-022-00014-0. Epub 2022 Mar 31.
Medical devices are subject to strict regulatory and approval processes to enter the market and to be used by operators and patients. These are needed to guarantee the users' safety. The different activities of these processes have important implications for all involved stakeholders and for the whole lifecycle of a medical device. The aim of this work is to provide an overview of some key aspects of the new EU Medical Device Regulation and to show why researchers, innovators and clinicians should care about it. Awareness of regulatory requirements can improve the innovation process and its efficiency in terms of both social and ethical impact, but this awareness needs to be raised in the upcoming months and years. One can shortly say "yes, one needs to take care" of the new EU Medical Device Regulation. First and foremost, it is crucial for the sake of the users' safety, which is the regulation's intrinsic goal. Second, it should not just be seen as an obstacle for new innovations in the medical domain, but as a chance as it can provide new opportunities.
医疗设备进入市场并供操作人员和患者使用需经过严格的监管和审批程序。这些程序是保障用户安全所必需的。这些程序的不同活动对所有相关利益方以及医疗设备的整个生命周期都具有重要意义。这项工作的目的是概述欧盟新的《医疗器械法规》的一些关键方面，并说明研究人员、创新者和临床医生为何应关注该法规。了解监管要求可以在社会和伦理影响方面改善创新过程及其效率，但在未来几个月和几年中需要提高这种认识。简而言之，可以说人们“需要关注”欧盟新的《医疗器械法规》。首先也是最重要的，这对于用户安全至关重要，而用户安全是该法规的内在目标。其次，不应仅仅将其视为医疗领域新创新的障碍，而应视为一个机会，因为它可以提供新的机遇。
