Is CE certification for products or companies?
CE certification is for products, not companies.
It proves the legality and conformity of products, involving aspects such as product safety, design, materials, manufacturing processes and performance. If a product meets the CE certification standards, it will be able to obtain a CE certification certificate and circulate freely in the European market. It should be noted that even products produced by the same company may need to be CE certified separately, because the CE mark is specific to specific products. In addition, not all products require CE marking, only products that comply with specific regulations and standards require it.
The process of CE certification includes the following steps:
The manufacturer or importer confirms whether the product requires CE certification and determines the applicable EU directives and standards.
Conduct a technical assessment to prove that the product complies with applicable directives and standards. The assessment can be conducted through internal testing or external testing agencies.
Prepare technical documents that meet EU requirements. The documents need to include detailed information on product design and manufacturing, such as materials used, process flow, test reports, markings and warnings.
Submit a CE certification application to the certification body and provide the above technical documents. The certification body will review the technical documents and conduct necessary tests and assessments.
If the product passes the review and test, the certification body will issue a CE certificate.
Technical documents to be prepared for CE certification
(1) Name and address of the manufacturer (EU Authorized Representative (EU Authorized Agent) AR), product name, model, etc.;
(2) Product instruction manual;
(3) Safety design documents (including key structural drawings, i.e. design drawings that reflect creepage distance, clearance, number of insulation layers and thickness);
(4) Product technical conditions (or enterprise standards), establish technical data;
(5) Product electrical schematics, block diagrams and circuit diagrams, etc.;
(6) List of key components or raw materials (please choose products with European certification marks);
(7) Test report;
(8) Relevant certificates issued by the EU authorized certification body NB (for modes other than mode A);
(9) Product registration certificate in the EU (for some products such as Class I medical devices, ordinary IVD in vitro diagnostic medical devices);
(10) CE Declaration of Conformity (DOC);
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