Pane Josep, Francisca Reynold D C, Verhamme Katia M C, Orozco Marcia, Viroux Hilde, Rebollo Irene, Sturkenboom Miriam C J M
Department of Medical Informatics, Erasmus Medical Center - University Medical Center Rotterdam, Rotterdam, Netherlands.
Department of Patient Safety, Alcon, Fort Worth, Texas.
Pharmacoepidemiol Drug Saf. 2019 Sep;28(9):1155-1165. doi: 10.1002/pds.4859. Epub 2019 Jul 18.
Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan.
This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow-up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device.
The PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.
近期涉及医疗器械的公共卫生安全问题导致对改进当前被动反应式上市后监督（PMS）系统的需求不断增加。欧盟各国主管当局已开始关注加强上市后风险评估。因此，新的欧盟医疗器械法规得以发布，其中包括PMS计划的概念。
本出版物回顾了欧洲议会和理事会关于医疗器械的第（EU）2017/745号新法规中附件III关于PMS的技术文件以及附件XIV B部分：上市后临床随访。
PMS活动的结果将在PMS计划中描述，并将用于更新其他相关文件。采用模块化方法构建PMS计划的内容将有助于持续更新其他PMS信息。我们建议PMS计划应包括PMS计划核心和PMS计划补充。PMS计划核心文件将描述PMS系统，PMS计划补充将概述制造商针对特定医疗器械开展的具体活动。
PMS计划可作为医疗器械获益-风险评估的全面工具。如果制定和实施得当，它将在建立医疗器械主动安全评估新框架中发挥关键作用。
