What is the European CE certification process? 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 the general quality requirements. The coordination directive only stipulates the main requirements, and the general directive requirements are the standard tasks. Therefore, the accurate meaning is that the CE mark is a safety conformity mark rather than a quality conformity mark. It is the "main requirement" that constitutes the core of the European Directive.

CE confirms the exporting country

If exported to any of the 30 member countries of the European Economic Area (EEA) including the European Union (EU) and the European Free Trade Agreement (EFTA), CE certification may be required.

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 directives corresponding to all categories. Note: Some products excluded from the directive are sometimes listed in some product directives.

CE EU authorized agent

Authorized Representative

In order to ensure that the four requirements in the implementation of the aforementioned CE Marking certification can be met, the EU law requires that manufacturers located outside the 30 EEA allies must appoint an EU authorized representative (EU authorized agent) in the EU to ensure the consistency of the product's "safety" in the circulation process and use period after the product is put on the European market; Technical files must be stored in the EU for inspection by the supervisory authority at any time; Remedial measures must be taken for products that are found by the market supervision authority to be not in conformity with CE requirements, or products that have been affixed with CE labels due to accidents during use. (e.g. temporarily removed from the shelf or permanently removed from the market); After the product model with the CE label has been put on the European market, if it encounters changes or changes in the relevant laws of the European Union, its subsequent products of the same model must also be changed or amended accordingly, so as to meet the new legal requirements of the European Union.

Mode required for CE certification

For almost all EU product directives, the directive usually provides manufacturers with several models of CE certification (Conformity Assessment Procedures), and manufacturers can choose the most suitable model according to their own conditions. Generally speaking, the CE certification mode can be divided into the following 9 basic modes,


Module A: Internal Production Control

Module Aa: Internal production control, plus third-party detection (Module Aa: Prevention of a Notified Body)

Module B: EC type-examination

Module C: Conformance to Type

Mode D: Production Quality Assurance



Module E: Product Quality Assurance

Module F: Product verification

Mode G: Unit Verification

Mode H: Full Quality Assurance


Based on the different combinations of the above basic models, several other different models may be derived. Generally speaking, not any model can be applied to all products. In other words, manufacturers are not allowed to choose any of the above modes to carry out CE certification for their products.

Self-declaration mode or must pass the third-party certification authority

The product directive of the European Union with a lower risk level allows manufacturers of products with a lower risk level in certain categories to choose to carry out CE certification in the way of mode A: "internal production control (self declaration)". Products with high risk level must be involved by the third party certification agency NB (Notified Body). For products with high risk level, the manufacturer must select other modes other than mode A, or mode A plus other modes to achieve CE certification. In other words, the third party certification body NB (Notified Body) must be involved.

In the certification process of other modes other than mode A, at least one EU approved certification body NB is usually required to participate in part or all of the certification process. According to different modes, NB may participate in the certification process in the following ways: incoming sample inspection, sampling inspection, factory inspection, annual inspection, different quality system audits, and issue corresponding test reports and certificates.

More than 1200 certification bodies have been recognized by the EU, most of which are located in the EU allies. Generally, an NB is only authorized by the EU to carry out certification in one or more modes for one or more categories of products. In other words, an EU-authorized certification body cannot certify all product categories. Even for its authorized product categories, it is usually not all authorized models. For each EU product directive, there is usually a list of authorized certification bodies for the product directive.


CE maintenance and update

Technical Files

EU law requires that after the products with CE labels are put on the European market, their technical documents must be stored in the EU for inspection by the supervisory authority at any time. If the contents contained in the technical documents are changed, the technical documents shall also be updated in a timely manner.

Technical documents shall generally include the following contents:

a . Name, trade name and address of manufacturer (EU authorized representative (EU authorized agent) AR).

b . Model and number of the product.

c . Product instructions.

d . Safety design documents (key structure drawings, i.e. design drawings that can reflect the creepage distance, gap, number of insulation layers and thickness).

e . Product technical conditions (or enterprise standards).

f . Product electrical schematic diagram.

g . Product circuit diagram.

h . List of key components or raw materials.

i . Testing Report.

j . Relevant certificates issued by EU authorized certification body NB (for other modes other than mode A).

k . The registration certificate of the product in the EU (for some products, such as Class I medical devices and ordinary IVD in vitro diagnostic medical devices).

l . CE Declaration of Conformity (DOC).