《MDD AGREEMENT》附件（一）：
《CE Technical File》
Part A
1) Name and address of the manufacturer 2) Name and address of EU Representative .
Trade or proprietary name(s), the common or usual name(s), the device classification(s) and rule(s) assigned by manufacturer in accordance with the relevant Directive Annex. 3) The name(s) and address(s)of the facilities
The name and address of any Notified Body involved 4) Declaration of Conformity
5) Essential Requirements Checklist
6) a brief description of the device(s) 7) Label and instructions of use
8) identification of technical standards with which compliance is claimed
9) a brief statement of the bench testing performed and clinical data obtained. This should make clear how the results of bench testing and clinical data are used to demonstrate compliance with the directive(s),and make reference to relevant part(s) of the manufacturer technical documentation 10) identification of technical standards with which compliance is claimed 11) a brief statement of the bench testing performed and clinical data obtained. This should make clear how the results of bench testing and clinical data are used to demonstrate compliance with the directive(s),and make reference to relevant part(s) of the manufacturer technical documentation
Part B 12) Risk anaysis 13) the clinical data
14) Vigilance System
15) the test reports
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16) Information concerning the quality manual, plans, descriptions of the products and processes, standards applied etc. as detailed in the previous section
If in need , at any time manufacturer must be able to provide the latest version documents that listed in part A and B to the EU representative office in the form written or electronic documents.
Documents that listed in Part B is not limited to the items above.
Documents listed in Part A are written in English ,while documents listed in Part B are written in Chinese.
文献来源：
公告机构决议 NB-MED/2.5.1/Rec5
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CE技术文件的要求(EN)
