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 "main requirement" that forms the core of the European Directive.

The "CE" logo is a safety certification logo and is regarded as a passport for manufacturers to open and enter the European market. CE stands for European Unity (CONFORMITE EUROPEENNE).

The "CE" sign in the European market is a compulsory certification mark. In order to circulate freely in the European market, whether products produced by enterprises within the European Union or products produced by other countries, the "CE" sign must be affixed to show that the product meets the basic requirements of the EU Directive "New Approach to Technical Coordination and Standardization". This is a mandatory requirement of EU law for products.

Certification authority

(1) Declaration of conformity/Declaration of compliance issued by enterprises independently belongs to self-declaration and should not be issued by third-party agencies (intermediaries or test certification bodies). Therefore, it can be replaced by the EU-format Enterprise Conformity Statement.

(2) Certificate of Compliance/Certificate of Compliance, which is a compliance statement issued by a third-party organization (intermediary or test certification body), must be accompanied by technical data such as test reports, TCF, and enterprises should also sign the Compliance Statement.

(3) EC Attestation of conformity Certificate of European Union Standard Compliance, which is a certificate issued by Notified Body (abbreviated as NB). According to EU regulations, only NB is eligible to issue the CE declaration of EC Type.

Authentication procedure

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 European Union EU and EFTA.

Confirm that if a product belongs to more than one category at the same time, it must meet the requirements listed in the corresponding product instructions for all categories. Note: Some product instructions sometimes list products that are excluded from the instructions.

EU Authorized Agent

Authorized Representative

In order to ensure that the four requirements mentioned above in the implementation of CE Marking certification are met, EU law requires manufacturers located outside the 30 EEA allies to appoint an Authorized Representative within the EU to ensure that products are "safe" during circulation and use after they are put into the European market. Consistency; Technical Files must be stored in the EU for inspection at any time; remedial measures must be taken for products found by market supervisory bodies that do not meet CE requirements, or products that have been labeled CE in the course of use due to accidents. (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.

Patterns required for authentication

For almost all EU product directives, the directives usually provide manufacturers with several models of CE certification (Modules). Manufacturers can tailor their clothes according to their own circumstances and choose the best model for themselves. Generally speaking, CE authentication mode can be divided into the following nine basic modes: Module A: internal production control

Model A: Internal production control (self-declaration)

Module Aa: Intervention of a Notified Body Model Aa: Internal Production Control plus Third Party Inspection

Module B: EC Type-examination mode B: EC type test

Communication product CE certification Module C: conformity to type

Mode C: conformance type 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: full quality assurance

Model H: Total Quality Assurance

Based on the different combinations of the above basic modes, several other different modes 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

The EU Product Directive allows manufacturers of certain categories of products with lower risk levels to choose Model A: "Internal

CE certification in the form of production control (self-declaration). 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 NB (Notified Body), a third-party certification body.

In the process of certification 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. [1]

Maintenance and update

(Technical Files)

EU law requires that after CE labeled products are put into 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. Name, trade name and address of the manufacturer (EU Authorized Representative (EU Authorized Agent) AR.

B. Model number of the product.

C. Instructions for the use of products.

D. Safety Design Document (Key Structural Diagram, which can reflect creeping distance, clearance, insulation layer number and thickness).

E. Technical conditions of products (or enterprise standards).

F. Electrical schematic diagram of the product.

G. Product circuit diagram.

H. List of key components or raw materials.

I. Testing Report.

J. Certificates issued by NB, the EU Authorized Certification Authority (for models other than Mode A).

K. Certificate of registration of products in the EU (for some products such as Class I medical devices, ordinary IVD in vitro diagnostic medical devices).

L. CE Compliance Statement (DOC).

Certificate template