MDR法规
Article 2 定义 Definitions
（1） “医疗器械”是指由制造商单独使用或组合用于人体的以下一种或多种特定医疗目的任何仪器、设备、器具、软件、植入物、试剂、材料或其他物品：
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
对疾病的诊断、预防、监护、预测、预后、治疗或缓解；
diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
对损伤或残疾的诊断、监控、治疗、缓解、补偿
diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
解剖、生理或病理过程或状态的研究、替代、调节，
investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
通过对来自人体的样本（包括器官、血液、捐献的组织）进行体外检测来提供信息。
providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
其效用主要通过物理等方式获得，不是通过药理学、免疫学或者代谢的方式获得，或者虽然有这些方式参与但是只起辅助作用；
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
以下产品也应视为医疗器械：The following products shall also be deemed to be medical devices:
具有控制或支持用途的器械。
devices for the control or support of conception;
专门用于器械的清洁、消毒或灭菌，如第 1（4）条和本点第一子段第中所述
products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point
单词扫盲
instrument 器械
apparatus 设备
appliance 器具
implant 植入
reagent 试剂
diagnosis 诊断
monitoring 监护
prognosis 预后
alleviation 缓解
compensation 补偿
disability 残疾
investigation 调查
modification 调节；修改
anatomy 解剖
physiological 生理
pathological 病理
specimens derived 样本来源
metabolic 代谢；新陈代谢
deemed to be medical devices 被视为医疗器械
specifically 具体的说；专门说
disinfection 消毒
sterilisation 灭菌
总结
医械香猪
