1. The relevant laboratory of the manufacturer (hereinafter referred to as the laboratory) makes an oral or written preliminary application.
2. The applicant fills in the CE mark application form and sends the application form, product description and technical documents to the laboratory (if necessary, the applicant company is also required to provide the prototype).
3. The laboratory determines the inspection standards and inspection items and makes a quotation.
4. The applicant confirms the quotation and sends the samples and relevant technical documents to the laboratory.
5. Technical documents provided by the applicant.
6. The laboratory issues a charge notice to the applicant, and the applicant pays the certification fee according to the charge notice.
7. The laboratory conducts product testing and reviews technical documents.
8. The review of technical documents includes:
A whether the document is perfect.
B whether the document is written in the official European language (English, German or French).
9. If the technical documents are not perfect or the specified language is not used, the laboratory will inform the applicant to make improvements.
10. If the test is unqualified, the laboratory will inform the applicant in time and allow the applicant to improve the product. So, until the test is qualified. The applicant shall revise the technical data in the original application so as to reflect the actual situation after revision.
1 1. For the rectification expenses involved in Article 9 and 10 on this page, the laboratory will issue a supplementary charge notice to the applicant.
12. The applicant requests to pay the rectification fee according to the supplementary fee notice.
13. The laboratory provides the applicant with the test report or technical document (TCF), CE certificate (COC) and CE mark.
14. The applicant signs the self-declaration of CE guarantee and affixes the CE mark on the product. CE certification program 1. Confirm the exporting country
If the EEA exported to the European Economic Area includes any of the 30 member countries of the European Union and the European Free Trade Agreement EFTA, CE certification may be required.
2. Confirm the product category and relevant EU product directives.
If a product belongs to more than one category at the same time, it must meet the requirements listed in the product specifications corresponding to all categories. Note: Some products not included in the manual are sometimes listed in some product manuals.
3. Designate an "authorized representative of the EU".
In order to ensure that the above-mentioned four requirements for implementing CE mark certification can be met, EU law requires that manufacturers located outside the 30 EEA allies must appoint an authorized representative in the EU to ensure the consistency of product "safety" in circulation and use after the products are put into the European market. Technical files must be kept in the European Union for inspection by supervisory agencies at any time; Remedial measures must be taken for products found by market supervision institutions that do not meet the requirements of CE, or products that have been labeled with CE during use. (such as temporary or permanent removal); After the CE mark product model is put into the European market, if the relevant EU laws change or change, the subsequent products of the same model must also be changed or modified accordingly to meet the new EU legal requirements.
4. Confirm the modules required for authentication.
For almost all EU product directives, directives usually provide manufacturers with several modules of CE (Conformity Assessment Procedure), and manufacturers can choose the most suitable one according to their own conditions. Generally speaking, CE certification mode can be divided into the following nine basic modes: Module A: Internal production control.
Mode A: Internal production control (self-declaration)
Module Aa: Intervention of Certification Body
Mode Aa: Internal production control, plus third-party inspection.
Unit b: EC type inspection
Mode B: EC type test
Communication product CE authentication module C: compliance type
Mode c: conform to the mode
Module d: production quality assurance
Mode d: production quality assurance
Module e: product quality assurance
Mode e: product quality assurance
Module f: product verification
Mode f: product verification
Module g: unit verification
Mode g: unit verification
Module H: Total Quality Assurance
Mode H: Total Quality Assurance
Based on the different combinations of the above basic patterns, several other different patterns can be derived. Generally speaking, not all models can be applied to all products. In other words, manufacturers are not free to choose any of the above modes for CE certification of their products.
5. Adopt "self-declaration" mode or "must pass the third-party certification body"
Low risk level (minimum risk).
The European Union's product directive allows manufacturers of some low-risk products to choose mode A: "internal production control (self-declaration)" for CE certification.
Products with high risk level must participate through a third-party certification body NB (Certification Body).
For high-risk products, the manufacturer must choose other modes except mode A, or mode A plus other modes to obtain CE certification. In other words, there must be a third-party certification body NB (the certified body) involved.
In the authentication process of other modes except Mode A, it is usually necessary for at least one certification body NB recognized by the European Union to participate in part or all of the authentication process. According to different modes, NB may be involved in the certification process through sampling inspection, sampling inspection, factory inspection, annual inspection and audit of different quality systems. , and issue the corresponding inspection report and certificate.
At present, more than 1200 certification bodies have been recognized by the EU, most of which are located in EU allies. Usually, the EU only authorizes NB to certify one or more types of products in one or more modes. In other words, it is impossible for EU- authorized certification bodies to certify all product categories, and even its authorized product categories are usually not authorized for all models. For each EU product directive, there is usually a directory of authorized certification bodies for NB product directives.
6. Establish technical files and maintain and update them.
According to EU law, after CE mark products enter the European market, their technical files must be kept in the EU for inspection at any time. If the contents contained in the technical documents change, the technical documents should also be updated in time.
Technical documents shall generally include the following contents:
A name, commodity name and address of the manufacturer (EU authorized representative (EU authorized agent) AR).
B. the model and serial number of the product.
C. product user manual.
D safety design documents (key structural drawings, that is, design drawings that can reflect climbing distance, gaps, quantity and thickness of insulation layers).
E. product technical conditions (or enterprise standards).
F. Electrical schematic diagram of the product.
G. product circuit diagram.
List of key components or raw materials.
First, the test report.
J relevant certificates issued by NB, an authorized certification body of the European union (applicable to modes other than mode a).
K product registration certificate in EU (for some products, such as Class I medical devices and ordinary IVD in vitro diagnostic medical devices).
Statement of length conformity.