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230问答网 > 医疗器械CE认证的流程是怎样的？

医疗器械CE认证的流程是怎样的？

2025-03-30 13:04:40

推荐回答（3个）

回答1：

按照93/42/EEC指令，首先要对器械进行分类，如果是I类器械，一般找个机构测试一下写个符合声明，找个欧代就行了。II类以上类别，建议按照指令附录2的认证方式，找一家有NB号的认证机构，按其要求建立质量体系，技术文档并做型式测试，审核通过即可取得CE证书。NB机构一定要选欧盟国家的。比如TUV SUD南德，BSI英标，捷克ITC等。

回答2：

做CE可以打我手机、我名字是我手机号意斯欧-小董

回答3：

具体流程看产品

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