MDR法规
1、首先是每个附录的名称在实际工作中应用非常广泛，一起打卡吧
附录 ANNEXES
I 通用安全与性能要求 General safety and performance requirements
II技术文件 Technical documentation
III上市后监管技术文件 Technical documentation on post-market surveillance
IV EC 符合性声明 EU declaration of conformity
V CE 符合性标识 CE marking of conformity
VI 根据第 29(4)和 31 条提交的注册器械和经济运营商信息，根据第 28 和 29 条提供给 UDI 数据库的核心数据元
素与 UDI-DI，和 UDI 系统
Information to be submitted upon the registration of devices and economic operators inaccordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with theUDI-DI in accordance with Articles 28 and 29;and the UDI system
VII 公告机构需满足的要求 Requirements to be met by notified bodies
VIII 分类标准 Classification rules
IX 基于质量管理体系的符合性评估和技术文件评估 Conformity assessment based on a quality management system and assessment of the technical documentation
X 基于型式检验的符合性评估 Conformity assessment based on type examination
XI 基于产品符合性验证的符合性评估 Conformity assessment based on product conformity verification
XII 由公告机构签发的证书 Certificates issued by a notified body
XIII 定制器械的流程 Procedure for custom-made devices
XIV 临床评价评价和上市后临床跟踪 Clinical evaluation and post-market clinical follow-up
XV 临床研究 Clinical investigations
XVI 在第 1（2）条中所述无预期医疗目的之产品分组清单 List of groups of products without an intended medical
purpose referred to in Article 1(2)
XVII 对比表 Correlation table
2、一般要求 GENERAL REQUIREMENTS
1.器械应具备制造商预期的性能，并确保其设计和结构在正常使用条件下适用于其预期用途。器械应安全有效，且不得对患者的临床症状或安全或者使用者或其他人员（如适用）的安全和健康造成损害，在最大限度保护健康和安全的同时，器械使用的可接受风险与其对患者的益处相比，应在可接受范围内，并应考虑到符合现有认知水平。
Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose.
They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.
单词扫盲
suitable for their intended purpose：适合其预期用途的。
applicable：适用的
compatible：兼容的；可共存的
坚持和我们一起打卡，你会变得不一样！！！！
