MDR法规
单词扫盲
reprocessing：再加工；后处理
single-use devices：一次性使用设备
complying：服从:
laid down：规定
assume：假设
obligations：义务:
Member States：成员国:
health institution：医疗机构
external：外部
divergence：差异；偏差；不同；散度 对应文中偏差的存在
incumbent：现任的；在职的
relevant harmonised standards：相关协调标准
provisions：规定
equivalent：相当于:
corresponding ：对应
2、应给予植入器械患者以明确且容易获得的，足够识别所植入器械的基本信息，以及关于该器械的其他信息，包括任何必要的健康风险警戒或需采取的预防措施，例如关于其是否与某些诊断器械或用于安全控制的扫描仪兼容的指示。
Patients who are implanted with a device should be given clear and easily accessible essential information allowing the implanted device to be identified and other relevant information about the device, including any necessary health risk warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.
单词扫盲
implanted：植入
precautions：预防措施
indications：标志；显示
3、一般来说，器械应具有CE标识，表明其符合本法规，以便其在欧盟内自由流通并根据其预期目的投入使用。成员国不得对符合本法规规定要求的器械，在其投放市场或投入使用方面制造障碍。不过，应允许成员国决定是否限制使用本法规未涵盖的任何特定类型的器械。
Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to the placing on the market or putting into service of devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.
单词扫盲
obstacles：障碍
总结
医械香猪
