Pharmacy Department, Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015, Paris, France.
University of Paris-Sud, Université Paris-Saclay, EA7358 GRADES, 5 rue Jean-Baptiste Clément, 92290, Châtenay-Malabry, France.
Cardiovasc Intervent Radiol. 2019 Sep;42(9):1272-1278. doi: 10.1007/s00270-019-02247-0. Epub 2019 May 23.
The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice.
In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations.
This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market.
In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.
2017 年 5 月 20 日起，《医疗器械法规》（MDR）2017/745/EU 将全面实施。介入放射学家每天都会使用医疗器械，因此必须了解这一新法规将对他们的日常实践产生的影响。
本文介绍了 MDR 给医疗器械行业带来的重大变革，重点介绍了临床评估和临床研究。
该法规显著加强了控制措施，以确保设备的安全性和有效性。此外，以前允许通过加速途径进入市场的等效性，现在仅在某些情况下才有可能。此外，MDR 还延长了上市后的临床随访，所有设备都需要进行。这些新要求可能会导致临床研究数量的大幅增加，并导致某些设备在市场上的供应延迟。
在未来几年，介入放射学家可能会受到这些变化的影响，包括医疗器械的可用性和/或更多地参与临床研究。
