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CE FAQ


What is the CE mark?
In recent years, the CE mark has been used more and more in the products sold on the market in the European Economic Area (European Union, European Free Trade Association member countries, except Switzerland). CE-marked products indicate that they comply with safety, health, Environmental protection and consumer protection requirements expressed in a series of European directives.
What does the letter CE stand for?
In the past, European Union countries have different requirements for imported and sold products. Goods manufactured according to one country's standards may not be available in other countries. As part of efforts to eliminate trade barriers, CE emerged as the times require. Therefore, CE stands for CONFORMITE EUROPEENNE. In fact, CE is also an abbreviation of the word "Community" in many languages of the European Community. Originally, the English phrase EUROPEAN COMMUNITY was abbreviated as EC. Later, the European Community was COMMUNATE EUROPEIA in French and COMUNITA EUROPEA in Italian. , Portuguese for COMUNIDADE EUROPEIA, Spanish for COMUNIDADE EUROPE, etc., so changed EC to CE. Of course, CE may also be considered as CONFORMITY WITH EUROPEAN (DEMAND).

What is the significance of the CE mark
The meaning of the CE mark lies in the fact that the CE acronym is used to indicate that the product affixed with the CE mark meets the essential requirements of the relevant European directives and is used to confirm that the product has passed the corresponding conformity assessment procedures and / or manufacturing The merchant's declaration of conformity has truly become a passport for products to be allowed to enter the European Union market. Industrial products that require the CE mark to be affixed in the relevant directives are not allowed to be sold on the market without the CE mark. Products that have been affixed to the CE mark and entered the market and are found to fail to meet safety requirements shall be ordered to withdraw from the market and continue to violate the relevant CE marking requirements Will be restricted or banned from entering the EU market or forced to withdraw from the market.
Does the CE mark prove that the quality is qualified?
The "main requirements" that form the core of the European Directive, need to be used for the purpose of formulating and implementing the Directive in the European Community's (85 / C136 / 01) "85 / C136 / 01" Resolution on New Approaches to Technical Coordination and Standards " "Main requirements" has a specific meaning, that is, it is limited to basic safety requirements for products that do not endanger the safety of humans, animals, and goods, rather than general quality requirements. The coordination directive only specifies the main requirements, which are standard tasks. If the product meets the relevant requirements of the relevant directives, it can be affixed with the CE mark, instead of deciding whether to use the CE mark according to the relevant standards for general quality. So the exact meaning is: CE mark is a safety conformity mark, not a quality conformity mark.
A kite with a CE mark does not mean that it can fly well, but only indicates that the kite meets safety regulations.
5. What products does the CE mark apply to? When will it begin?
As of April 2019, the directives issued by the European Community to implement the CE mark are as follows:

The New Legislative Framework consists of:
  • Regulation (EC) 765/2008 setting out the requirements for accreditation and the market surveillance of products
  • Decision 768/2008 on a common framework for the marketing of products, which includes reference provisions to be incorporated whenever product legislation is revised. In effect, it is a template for future product harmonisation legislation
  • Regulation (EC) 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another EU country.

Alignment of product legislation

A main objective of the Commission is to bring product harmonisation legislation in line with the reference provisions of Decision 768/2008 / EC . The following directives and regulations were aligned with these reference provisions:

  1. Toy Safety-Directive 2009/48 / EU
  2. Transportable pressure equipment-Directive 2010/35 / EU
  3. Restriction of Hazardous Substances in Electrical and Electronic Equipment-Directive 2011/65 / EU
  4. Construction products-Regulation (EU) No 305/2011
  5. Pyrotechnic Articles-Directive 2013/29 / EU
  6. Recreational craft and personal watercraft-Directive 2013/53 / EU
  7. Civil Explosives-Directive 2014/28 / EU
  8. Simple Pressure Vessels-Directive 2014/29 / EU
  9. Electromagnetic Compatibility-Directive 2014/30 / EU
  10. Non-automatic Weighing Instruments-Directive 2014/31 / EU
  11. Measuring Instruments-Directive 2014/32 / EU
  12. Lifts-Directive 2014/33 / EU
  13. ATEX-Directive 2014/34 / EU
  14. Radio equipment-Directive 2014/53 / EU
  15. Low Voltage-Directive 2014/35 / EU
  16. Pressure equipment-Directive 2014/68 / EU
  17. Marine Equipment-Directive 2014/90 / EU
  18. Cableway installations-Regulation (EU) 2016/424
  19. Personal protective equipment-Regulation (EU) 2016/425
  20. Gas appliances-Regulation (EU) 2016/426
  21. Medical devices-Regulation (EU) 2017/745
  22. In vitro diagnostic medical devices-Regulation (EU) 2017/746

6. How to use the CE mark when a product is covered by multiple directives at the same time?
When a product is covered by multiple directives at the same time, the CE mark can only be affixed to the product after all the products comply with the relevant directives. For example, if only a safety inspection (low-voltage test) is performed on an energy-saving lamp, it does not constitute a sufficient condition for using the CE mark. The CE mark can only be applied after the low-voltage directive and the electromagnetic compatibility directive are met at the same time.
7. What are the types of CE Marking modes that manufacturers can choose from?
At present, there are eight types of EU-approved CE Marking modes:
(1) Factory self-control and certification.
Module A (internal production control):
1. For simple, high-volume, non-hazardous products, only for manufacturers applying European standards.
2. The factory conducts self-conformity assessment and self-declaration.
3. Technical documents are submitted to state agencies for storage for ten years. Based on this, review and inspection can be used to determine whether the product complies with the directive. The manufacturer even provides product design, production and assembly processes for inspection.
4. There is no need to declare that its production process can always guarantee that the product meets the requirements.
Module Ab:
1. The manufacturer does not produce according to European standards.
2. The testing agency conducts random tests on the special parts of the product.
(2) Evaluation by the testing organization.
Module B (EC type review):
The factory sends samples and technical documents to the testing institution of its choice for review, and the testing institution issues a certificate.
Note: B alone is not enough to constitute CE use.
Module C (consistent with type [sample]) + B:
The factory makes a declaration of conformity (in accordance with the type approved), and the declaration is kept for ten years.
Module D (production process quality control) + B:
This model focuses on the production process and the control of the final product. The factory produces according to the method approved by the testing organization (quality system, EN29003), and on this basis declares that its products are consistent with the type of certification (declaration of conformity).
Module E (Product Quality Control) + B:
This mode only focuses on the final product control (EN29003), the rest is the same as Module D.
Module F (Product Test) + B:
The factory guarantees that its production process can ensure that the product meets the requirements before making a declaration of conformity. Accredited testing organizations verify the compliance of their products through full inspection or sampling inspection. The test agency issues a certificate.
Module G (test one by one):
The factory declares that it complies with the requirements of the directive, and submits the product technical parameters to the testing institution, and the testing institution issues a certificate after inspecting the products one by one.
Module H (Integrated Quality Control):
This model focuses on design, production process, and final product control (EN29001). The rest is the same as Module D + Module E. Among them, mode F + B and mode G are suitable for products with particularly high risks.
8. What legal procedures are required to use the CE mark?
Manufacturers can follow these main steps:
1. According to the requirements of the directive on which conformity assessment mode should be adopted to use the CE mark, the principles of conformity assessment, and the Council Directive 93/465 / EEC, select the appropriate mode among the eight certification modes.
2. After taking a self-assessment or applying a third-party assessment or compulsory application to the European Community notification procedure for accreditation of a certification body according to the requirements of the directive, the manufacturer ’s self-assessment statement of conformity and / or the CE certificate of the accreditation body shall be prepared as acceptable or permitted Prerequisites for CE marking.
3. After passing the conformity assessment of the prescribed mode, the manufacturer shall make or attach the CE mark and additional information required by the relevant directive by the manufacturer according to the relevant directive.
4. The relevant directive stipulates that when the CE mark is attached, and then the identification number of the accreditation certification body is attached, the accreditation certification body performing the conformity assessment should attach it by itself, or the manufacturer or its agent in the European Community is responsible for attaching it. For products that are particularly dangerous, the directive stipulates that a product sample test and / or quality system approval by a compulsory accreditation and certification body must first obtain an assessment approval before being allowed to use the CE mark.
Who is the recipient of the CE mark?
The CE mark is accepted by the national regulatory authorities of the member states of the European Community responsible for implementing market product safety control, not customers. When a product has the CE mark, the authority responsible for sales safety supervision of the member states should assume that it is in compliance with the directive. Requirements, free circulation in the European Community market.
10. Who is responsible for the correctness of the CE mark?
Manufacturers or their agents, or importers in EU member states must be responsible for the correctness of the CE mark.
11. Is the CE mark available for advertising?
The CE mark is designed for official market product safety control. It is not made for consumers or a marketing tool, so it is not suitable for advertising. However, when making your product catalog, don't forget to print the legally obtained CE mark on the catalog.
12. Who grants the CE mark?
The CE mark is not issued by any official authority, certification body or testing laboratory, but should be made and affixed by the manufacturer or its agent according to one (or a mixture) of the eight modes mentioned above.
Is there a standard format for the CE declaration of conformity?
The directive does not specify a fixed format, but many certification bodies have designed their own fixed format.


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