{:en}Technical File{:}{:zh}技术文件{:}


A Technical File is proof that a medical device complies with the essential safety and health requirements set down by the relevant Directive(s). Technical Files are required for all classes of medical devices – Class I, Is, Im, IIa, IIb, III – and they must hold essential information about the medical device, including photographs and diagrams. A Technical File can be compiled in any of the official languages of the EU. However, English is the most commonly used. An up to date electronic or hard copy of the file needs to be kept available in Europe allowing it to be presented to any EU Competent Authorities upon request. Manufacturers based outside the EEA are to make it available at the address of their European Authorized Representative. As part of the CE Marking process, it is also advised that an external expert reviews the Technical File. For more information about Technical Files, please see our Technical File Compliance page.

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技术文件是用于证明一个医疗器械(Medical Device)符合有关指令规定的基本安全和健康要求的文件。所有类别的医疗器械都要求有技术文件–I类,Is,Im,IIa,IIb,III–他们都必须保有医疗设备的基本信息,包括照片和图表。技术文件可以使用任何欧盟官方语言(Official languages of EU)编写。然而,英语是最常用的。一份最新的电子或纸质文件需要保存在欧洲,以便它能在任何要求的时候提交给任何欧盟主管当局。欧洲经济区以外的制造商需要使其可用于他们的欧盟授权代表(EAR)的地址。作为CE标志过程的一部分,我们也建议您用一位外部专家审查您的技术文件。有关技术文件的更多信息,请参阅我们的技术文件合规页面Technical File Compliance page.

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in Medical Devices Directive