各位讀者朋友，這幾天一直在收集關於進口歐盟時發現不被認可的Declaration Of Conformity（企業符合性聲明）的情況。有好多國內工廠急於轉行投產醫療物資並出口，但對進口國驗核要求知之甚少，導致貨物被退回或者存在後續國外索賠風險；國內也有許多“檢測機構”做出的testing report其實到了國外人家也不認……
Declaration Of Conformity這個東西，在歐盟就像“企業自我聲明”在中國一樣普遍。無論是歐盟醫療器械指令93/42/EEC(MDD)、EU2017/745（MDR）（注：MDR指令延期至2021年5月26日實施），還是歐盟個人防護設備指令EU2016/425（PPE），其指令內容中都有提及Declaration Of Conformity。
例如，以下是關於醫療器械產品EC Declaration Of Conformity的說明（出處：
https://eur-lex.europa.eu/eli/dir/1993/42/2007-10-11）
EC DECLARATION OF CONFORMITY
▼M5
1.
The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.
2.
The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.
可見，對於MDD指令下的DECLARATION OF CONFORMITY可以是生產廠商自己出具，也可以委託給授權代表出具。但是就筆者個人觀點，生產廠商自己出具的難度很高，因為要符合歐盟指令下關於assessment of the conformity of the product 的要求：
“The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular:
▼M5
— a general description of the product, including any variants planned and its intended use(s),
▼B
— design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc.,
— the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operations of the product,
— the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full,
▼M5
— in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,
▼B
— the results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer”
因此，鑑於上述出具企業自我符合性聲明的要求，還是建議製造企業尋找第三方授權機構出具吧！
接著講第二個問題，第三方授權機構怎麼找？
以醫療器械為例，
進口歐盟
以上這個表格就很清楚了，一定要是公告機構，並且還需查詢公告機構可以進行的醫療器械認證範圍，包括可以認證的醫療器械產品、認證模式，還是比較複雜的。例如，非無菌醫用口罩，那必須按照如下圖所示這樣篩選：
進口歐盟
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
所以，如果是別的醫療器械，您還得知道該種醫療器械在歐盟體系中的分類以及認證模式，還是建議向這些公告機構諮詢。
那麼國內朋友也會問，當地沒有分支機構沒有渠道可以諮詢，該怎麼辦呢？
認監委出臺的公告：
認監委關於對口罩、防護服等防疫用品領域認證活動有關要求的通知
國認監〔2020〕2號
進口歐盟
“四、做好認證服務。應向口罩、防護服等防疫用品企業提供優質認證服務，向企業傳遞準確的防疫用品國內外准入要求、質量標準及認證要求等信息；指導企業嚴格落實相關要求，提升企業產品質量；嚴禁虛假宣傳，嚴禁哄抬認證價格；經批准並具備歐盟CE公告機構業務分包資質的認證機構，應加強與境外公告機構的溝通協調，提高出口證書發證效率。”
我國具備歐盟CE公告機構業務認證資質的機構，筆者在歐盟ESF官網上找到了我國授權機構（
https://www.cnas.org.cn/english/photonews/03/902316.shtml），
這些機構可以按照國內標準進行檢測，但是CE認證證明還是得由歐盟公告機構出具。
進口歐盟
（部分截圖）
The China National Accreditation Service (CNAS) has published a list of laboratories accredited for testing of masks (protective and medical) on their website. Remark : Chinese accredited laboratories are certainly not Notified Body for respiratory protection and thus cannot issue EU Type Examination Certificates, they can perform the testing according to the tests for which they are accredited (in the majority of cases this is only to the Chinese standards, not to the EN standards)
最後我們來看看那些假的Declaration Of Conformity
進口歐盟
證面內容和CE認證證書一樣，不符合個人防護設備指令下關於DoC出具的內容要求，並且ISP這家認證機構並不屬於PPE指令下的公告機構。
進口歐盟
在PPE指令下無法找到這家“公告機構”。the organisation GTS informed us that this is a fake document that was not issued by themselves ((the reference on the document is an existing reference for a document related to a Forehead thermometer and RoHS legislation)
進口歐盟
這家香港的檢測中心沒有出具CE符合性聲明的資質。This certificate of conformity is issued by a Hong Kong testing lab that is not entitled to issue CE conformity certificates.
進口歐盟
企業符合性聲明/CE認證證書只能由歐盟公告機構出具。Conformity certificates /CE certificates cannot be issued by Chinese testing laboratories, only by European notified bodies.
進口歐盟
VIC機構不是歐盟官方的公告機構。The institute is not a notified body.
