对于医疗器械CE认证企业来说，务必要了解欧盟是由27个成员国组成，只有少数国家比如爱尔兰的母语为英语。其他国家都有自己的其他官方语言。最近，欧盟发布了指南文件，总结了成员国的语言要求，供制造商和进口商参考。
对于医疗器械CE认证企业来说，务必要了解欧盟是由27个成员国组成，只有少数国家比如爱尔兰的母语为英语。其他国家都有自己的其他官方语言。最近，欧盟发布了指南文件，总结了成员国的语言要求，供制造商和进口商参考。
每个国家对于医疗器械的相关文件（标签/说明书，植入卡，EU符合性声明，市场安全通知（召回），符合性评价相关的文件，软件的用户界面）中使用各种语言，都有自己的要求。
请您注意：出口到对应国家的器械，相关的文件必须使用规定的语言。否则属于不合规，货物在海关就有可能被阻挡，不允许入关！
MDR - language requirements for manufacturers
(January 2024)
Regulation (EU) 2017/745 on medical devices (MDR) contains different legal provisions that allow Member States to determine language requirements for manufacturers at
national level for information accompanying the device. The following table gives an overview of the national provisions, in the case that Member States have made use of the
possibility to determine language requirements for manufacturers. Member States are not obliged to determine a specific language. Having regard to the costs related to
providing information in various languages, Member States are encouraged to consider whether information to be provided by the manufacturer could be accepted in another
language than their national language (e.g. in English) if the safe use of the device is not compromised, especially regarding devices for professional use.
The below information is provided based on the information available to the Commission services following a consultation of the Medical Device Coordination Group (MDCG) in
October 2023. The Commission services do not take responsibility for the correctness of the information in the table. In any case, the provisions of the MDR and the provisions
of the Member States implementing the MDR in respect of language requirements take precedence over the information in this table.
如有医疗器械CE认证（MDR）咨询服务需求，欢迎您随时方便与杭州证标客医药技术咨询有限公司联络，联系人：叶工，电话：18058734169，微信同。