CE certification is limited to the basic safety requirements of products that do not endanger the safety of human beings, animals and goods, rather than general quality requirements. Coordination directives only specify major requirements, and general directive requirements are standard tasks. Therefore, the exact meaning is: CE mark is a safety qualification mark rather than a quality qualification mark. It is the core of the European Directive.”Main requirements “。“CE”The logo is a safety certification mark and is regarded as a passport for manufacturers to open and enter the European market. CE stands for European unity.In the European Market “CE”The logo is a compulsory certification mark. Whether it is products produced by enterprises within the EU or products produced by other countries, if they want to circulate freely in the EU market,It must be affixed.“CE”Signs,To show that the product conforms to the EU《New Method of Technical Coordination and Standardization》Basic requirements of instructions.This is a mandatory requirement of EU law for products.
Authentication Procedure
1. Recognition of Exporting Countries
CE certification may be required if the EEA is exported to any of the 30 member countries of the European Economic Area, including the EU EU and EFTA.
2. Confirmation of Product Categories and EU Related Product Directives
If a product belongs to more than one category at the same time, the requirements listed in the product instructions corresponding to all categories must be met.Note: Some product instructions sometimes list products that are excluded from the instructions.
3. EU Authorized Agent
In order to ensure the above CE logo (CE Marking ) Four requirements have been met in the process of certification implementation. The EU legal requirements are located in 30 EEAs. Manufacturers outside the EU must appoint an EU authorized representative (EU authorized agent) within the EU.(Authorized Representative),To ensure that products are delivered to the European market during circulation and use“security”Consistency; technical documentation.(Technical Files)It must be deposited in the EU for inspection at any time; remedial measures must be taken against products found by market supervision agencies that do not meet CE requirements, or products that have been labeled CE in the course of use but have been accidentally used.(For example, temporarily removed from the shelves or permanently removed from the market); after the CE-labeled product model is put into the European market, if there are any changes or changes in the relevant laws of the EU, the products of the same type produced subsequently must be changed or amended accordingly in order to meet the new legal requirements of the EU.
4. Patterns required for authentication
For almost all EU product directives, the directives usually provide manufacturers with several CE certification modes. Manufacturers can tailor their clothes according to their own circumstances and choose the most suitable mode for themselves. Generally speaking, CE authentication mode can be divided into the following nine basic modes:
Pattern A: Internal Production Control (Self-declaration)
Pattern Aa: Internal production control,Add third party testing
Pattern B: EC Type test
Pattern C: Conformity type
Pattern D: Production Quality Assurance
Pattern E: Product Quality Assurance
Pattern F:Product Verification
Pattern G: Unit Verification
Pattern H: Total Quality Assurance
Based on different combinations of the above basic models, several other models may be derived. Generally speaking, not every model can be applied to all products. In other words, the manufacturer is not free to choose any of the above models for CE certification of its products.
Self-declaration mode or through third-party certification bodies
EU Product Directives with Lower Risk Level Allow Manufacturers of Products with Lower Risk Level in Certain Categories to Choose Models A: “Internal Production Control (Self-declaration)”CE certification.Products with high risk level must be involved through the third-party certification body NB (Notified Body). For products with high risk level, the manufacturer must choose other modes besides mode A, or mode A plus other modes to achieve CE certification. That is to say, it is necessary to intervene through the third-party certification authority NB (Notified & nTotal Quality Assurance bsp; Body).
In the certification process of other modes besides mode A, at least one EU accredited certification authority NB is usually required to participate in part or all of the certification process. According to different modes, NB may intervene in the certification process by sampling inspection, sampling inspection, factory inspection, annual inspection, different quality system audit, and so on, and issue corresponding inspection reports, certificates, etc.
More than 1,200 certification bodies have been recognized by the European Union, the vast majority of which are located in EU allies. Usually, an NB is only authorized by the EU to authenticate under one or more modes for one or more categories of products. In other words, it is impossible for an EU-authorized certification body to authenticate all product categories, and even for its authorized product categories, it is usually not an authorized model. For each EU product directive, there is usually an NB directory of authorized certification bodies for the product directive.
Technical documentation
EU law requires that after CE labeled products are put on the European market, their technical Files must be stored in the EU for inspection by supervisory bodies at any time. If the contents contained in the technical documents change, the technical documents should also be updated in time.
Technical documents should normally include the following:
a . The name, trade name and address of the manufacturer (EU Authorized Representative (EU Authorized Agent) AR.
b . The model number of the product.
c . Instructions for the use of products.
d . Safety Design Document (Key Structural Diagram, which can reflect climbing distance, clearance, insulation layer number and thickness).
e . Product technical conditions (or enterprise standards).
f . Electrical schematic diagram of the product.
g . Product line diagram.
h . List of key components or raw materials.
i . Test Report (Testing Report)。
j . Relevant certificates issued by the EU Authorized Certification Authority NB (for models other than Mode A).
k . Registration Certificate of Products in EU For some products such as Class I medical devices, ordinary IVD in vitro diagnostic medical devices.
l . CE compliance statement (DOC).
European CE Certification