Procedures and conditions for obtaining CE certification

CE certification is based on the mode of the compliance system, and most of the directives allow manufacturers and their representatives to choose one or more modes to represent compliance with the directives. Generally speaking, there are three ways to comply.

Self declaration

Applicable to products without compulsory certification. The self declaration shall be made by the manufacturer or certification body in accordance with the applicable directives and reconciliation standards. In addition, the self declaration shall include the preparation of the declaration of conformity and CE mark.

verification

a) Compulsory verification (EC type verification) most products and machinery do not need compulsory verification; however, some specific products need certification issued by EU certification authority; and some specific products (such as machinery and medical products), you need to have EC type verification certificate.

b) Voluntary verification (type verification, test mark) manufacturers often entrust EU verification agencies to test and verify them to prove that they meet the market demand, and provide positive and factual proof of product responsibility, and have the accuracy of technical files, with test reports, which is also conducive to product marketing. The spontaneous verification also requires the manufacturer to prepare the declaration of conformity and affix the CE certification mark.

3. Technical documents

All compliance models require technical documentation and should include the following:

Declaration of conformity (and / or certification of controlled products)

·Manufacturer's name, address and product identification

·Name and address of agent in Europe

·List reconciliation criteria to be followed and / or measures to meet basic safety and health requirements

Product description (model, product name, etc.)

·Operation manual

·All plans for the product

·Test report

·Design details, operating instructions, parts lists, test rationale, circuit diagrams, including all necessary items to meet basic requirements such as health and safety.

The manufacturer or EU representative shall be fully responsible for the correctness of the technical documents and conformity statements. Manufacturers must implement internal operations to ensure product compliance. After the production of the last batch of products, the technical documents shall be kept in an area for at least ten years for inspection and verification.