英国医疗器械

官方法规原文：
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which—
(a) is intended by the manufacturer to be used for human beings for the purpose of—

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

(iii) investigation, replacement or modification of the anatomy or of a physiological process;

(iv) control of conception;

(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means;

and includes devices intended to administer a medicinal product or which incorporate a substance that would be a medicinal product if used separately, with its action ancillary to the device.

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、材料或其他物品，含配套附件及实现其正常用途所需的诊断/治疗类专用软件；
制造商预期用途需满足以下任一情形：

1. 疾病的诊断、预防、监测、治疗或缓解；

2. 损伤或残疾的诊断、监测、治疗、缓解或补偿；

3. 解剖结构或生理过程的探查、替代或改造；

4. 受孕控制（避孕）。

同时满足：核心预期用途并非通过人体内部/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；

含给药器械、内嵌药物成分（药物作用仅辅助器械功效）的组合产品，也纳入医疗器械范畴