Vasiljeva Ksenija, van Duren Bernard H, Pandit Hemant
Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), Chapel Allerton Hospital, University of Leeds, Chapeltown Road, Leeds, LS7 4SA UK.
Indian J Orthop. 2020 Feb 6;54(2):123-129. doi: 10.1007/s43465-019-00013-5. eCollection 2020 Apr.
Up until 2017, medical devices were placed on the European Union's (EU) single market in accordance with either Medical Device Directive 93/42/EEC for general medical devices or Medical Device Directive 90/385/EEC for active implantable devices. However, some devices that complied with these directives still failed catastrophically. In the orthopaedic device field, these failures were most pronounced in metal-on-metal hip devices causing severe patient morbidity with increased need for revision surgery which had unpredictable outcomes. Subsequently, the newly introduced Medical Device Regulations 2017/745 are aimed at addressing patient safety based on previous experience and thorough device assessment prior to and post-release on the EU single market; to accommodate for this they are substantially different (and more stringent). This poses a greater challenge for manufacturers and regulatory bodies in terms of time and resources.
A review of the EU directives and published literature was undertaken. This review provides the rationale behind this change and its potential impact on research, industry, and clinical practice.
The change in legal requirements for the medical devices to be put on the EU single market ultimately leads to increased patient safety, which is supported by clinical professionals. The new requirements for data transparency, post-market surveillance, and implant information availability increase the chance of catastrophic failure prevention. However, the exact method of implementation remains uncertain, and some essential rules on the data requirements for compliance have not yet been published by the EU. These limitations may limit the availability of products on the market including withdrawal of existing devices and a decrease in new medical device innovation. It is speculated that lack of new technologies within the medical device area can dramatically affect patient safety itself by not allowing potentially safer materials and methods on the EU single market, as the focus for the manufacturer becomes existing devices.
直到2017年，医疗设备依据《欧盟通用医疗设备指令93/42/EEC》或《欧盟有源植入式设备指令90/385/EEC》进入欧盟单一市场。然而，一些符合这些指令的设备仍遭遇了灾难性故障。在骨科设备领域，此类故障在金属对金属髋关节设备中最为显著，导致患者出现严重病症，翻修手术需求增加，且手术结果不可预测。随后，新出台的《2017/745号医疗器械法规》旨在基于以往经验以及在欧盟单一市场投放前和投放后的全面设备评估来解决患者安全问题；为此，这些法规有很大不同（且更为严格）。这在时间和资源方面给制造商和监管机构带来了更大挑战。
对欧盟指令和已发表文献进行了综述。该综述阐述了这一变化背后的基本原理及其对研究、行业和临床实践的潜在影响。
欧盟单一市场上医疗设备法律要求的变化最终提高了患者安全性，这得到了临床专业人员的支持。对数据透明度、上市后监测和植入物信息可用性的新要求增加了预防灾难性故障的可能性。然而，具体的实施方法仍不确定，欧盟尚未公布一些关于合规数据要求的基本规则。这些限制可能会限制市场上产品的供应，包括现有设备的撤市以及新医疗器械创新的减少。据推测，医疗器械领域缺乏新技术可能会极大地影响患者安全本身，因为这使得潜在更安全的材料和方法无法进入欧盟单一市场，因为制造商的重点变成了现有设备。
