在欧盟的医疗器械指令（MDD）的正文中，没有提到上市后监督（PMS）。只是在附录中简单提及。但是在医疗器械法规（MDR）的开篇(条款1之前）第20，23，32，33，34，41和74条提到了PMS/PMCF（post-market clinical follow-up, 上市后临床跟踪）。之后有18个条款（Article 83-100）对上市后活动（包括PMS，PMCF，警戒（vigilance），市场监督（market surveillance））做出具体规定。上市后监督为什么这么重要？

MDR的来源和两个丑闻有关，一个是金属对金属（metal on metal， MoM)髋关节置换植入物事件（在MDR的来源中有描述），另一个和乳房植入物有关。法国 Poly Implant Prothese 公司使用由廉价的工业级硅胶制成的未经批准的 PIP 植入物，导致植入物破裂的速度是行业平均水平的两倍。其造成的破坏在规模和时间长度上令人震惊。结果，欧洲各地成千上万的妇女受伤或处于危险之中，PIP 的创始人于 2013 年入狱。这些国际丑闻，促成了医疗器械监管的许多变化，这些变化由新的欧盟MDR引入。但MDR的变化也意味着每个医疗器械制造商及其相关经济运营商的PMS责任的增加。

一个医疗器械从研发到上市，再退市，上市后时间占了绝大部分。而且制造商也会希望其器械一直占领市场。所以上市后的产品表现非常重要，这些都由PMS来保证。如果有问题，及时发现并改进。如果无法改进，则及时退市。当年的MoM事件，如果制造商做好PMS，发现问题，立即召回，就有可能减少对患者的伤害。如果主管机构做好市场监督，并及时反应，PIP丑闻也不会有那么多的受害者。

PMS如此重要，它成为保证医疗器械安全有效性的三大支柱（风险管理（risk management)，临床评价（clinical evaluation）和上市后监督（PMS)）之一。制造商需要对PMS 取得的数据进行风险分析，再使用临床评价来评估临床收益（clinical benefit）是否大于风险(outweigh risk)。

虽然MDD下具有CE标记的产品到2024年还可以销售，但是也要符合MDR 下的PMS要求, 定期对PMS数据进行评估，比之前严格多了。如果做不好，年检无法通过，有失去证书的风险。

在中国，新的医疗器械监督管理条例自2021年6月1日起施行。其中第二十条指出医疗器械注册人、备案人应当履行下列义务：

（一）建立与产品相适应的质量管理体系并保持有效运行；

（二）制定上市后研究和风险管控计划并保证有效实施；

（三）依法开展不良事件监测和再评价；

（四）建立并执行产品追溯和召回制度；

（五）国务院药品监督管理部门规定的其他义务。

这与2017年开始实施的MDR的开篇第32，41和74条比较类似。这也说明了重视医疗器械的PMS是全球性的趋势。

“(32) To ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question. In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions.

(41) The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those settings.

(74) Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set up under their quality management system and based on a post-market surveillance plan. Relevant data and information gathered through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the purpose of transparency.”