CE技术文件的要求(EN)(最新整理)

1、mdd agreement附件（一）：ce technical filepart a1) name and address of the manufacturer2) 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) t

2、he name(s) and address(s)of the facilitiesthe name and address of any notified body involved4) declaration of conformity5) essential requirements checklist6) a brief description of the device(s)7) label and instructions of use8) identification of technical standards with which compliance is claimed9

3、) 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 documentation10) iden

4、tification of technical standards with which compliance is claimed11) 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

5、relevant part(s) of the manufacturer technical documentationpart b12) risk anaysis 13)the clinical data 14)vigilance system 15)the test reportstv product servicejiangsu tv product service co., ltd. 2005-08-16beijing branchpage 2 of 216)information concerning the quality manual, plans, descriptions o

6、f the products and processes, standards applied etc. as detailed in the previous sectionif 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 li

7、sted 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“”“”at the end, xiao bian gives you a passage. minand once said, people who learn to learn are very happy people. i

8、n every wonderful life, learning is an eternal theme. as a professional clerical and teaching position, i understand the importance of continuous learning, life is diligent, nothing can be gained, only continuous learning can achieve better self. only by constantly learning and mastering the latest relevant knowledge, can employees from all walks of life keep up with the pace of enterprise development and innovate to meet the needs of the market. this do