欧洲医疗器械

MDR官方原文
‘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:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

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.

The following products shall also be deemed to be medical devices:

- devices for the control or support of conception;

- products specifically intended for the cleaning, disinfection or sterilisation of devices.

医疗器械，指制造商拟用于人体、可单独或组合使用的任何仪器、装置、器具、软件、植入物、试剂、材料或其他物品，其预期用途满足以下一项或多项特定医疗目的：
1. 疾病的诊断、预防、监测、预测、预后、治疗或缓解

2. 损伤或残疾的诊断、监测、治疗、缓解或补偿

3. 解剖结构、生理/病理过程或状态的探查、替代或改造

4. 通过对人体样本（含器官、血液、捐献组织）进行体外检测提供医疗信息

同时满足：核心作用并非通过人体内部/体表的药理学、免疫学或代谢方式实现，此类方式仅可起辅助作用。

法定视同医疗器械的产品：
        - 避孕与受孕调控相关器械；
        - 专门用于器械清洁、消毒、灭菌的产品。