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Tuesday, June 1, 2010

BASIC Fundas of CE Marking

CE mark

From Wikipedia, the free encyclopedia

The CE mark

The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. CE stands for Conformité Européenne, "European conformity" in French.



Risk Assessment and CE Marking

Introduction to Risk Management and CE Marking

One of the techniques growing in importance in meeting the CE marking requirements is Risk Management including the steps of Risk Analysis and Risk Assessment. A defined process of assessing and managing risk throughout all stages of the life of a product is an important part of determining whether it is safe, and remains safe, to operate. A Technical File is expected to contain details of the Risk Management undertaken.

Atlantic Bridge can assist you to meet the requirements for Risk Management. As well as providing you with copies of the relevant European Standards, we can provide the necessary procedures and forms most suitable for your products.

Risk Assessment for Machinery - EN 1050:1996

EN 1050 should be used as a basis for any risk assessment of Machinery and ATEX equipment. The standard does not specify the precise method but provides detailed guidance as to what should be considered. It covers Hazard Identification providing a list in Annex A to the Standard. The elements to be considered in Risk Estimation are listed, and general advice is given on Risk Reduction. The Standard states that the documentation shall demonstrate the procedure and the results.

Risk Management for Medical Devices

The Risk Management Standard for Medical Devices is EN ISO 14971:2000. The Standard covers risk management throughout the life of a medical devices and for each phase of that life. It includes the required content of the Risk Management File and in the Annexes lists likely hazards. The standard does not provide documentation or a methodology for Risk Assessment but refers out to methodologies such as FMECA. Atlantic Bridge can provide suitable methods to conduct Risk Management to EN ISO 14971:2000.


Provision and Use of Work Equipment Regulations. (PUWER)

Assessment is carried out in a similar fashion to that required for "CE" Marking but additional emphasis is put onto the operational side of the equipment and the assessment must include the position and environment selected for the equipment when in use.

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The NORMAPME booklet on standardisation and CE-marking for SMEs is available HERE

CE Marking & Conformity

A product, service or process can comply with a standard or/and one or many New Approach Directive(s). This conformance is shown by a certificate of conformity and performed by aconformity assessment process. Conformity with a standard or a New Approach Directive may need third party certification by a test laboratory, often called a Notified Body. They are listed in the following websites: NANDO IS (for all New Approach sectors but construction) and NANDO CPD (for construction products).

Compliance with a standard is always done on voluntary basis. When a product falls under the scope of one or many New Approach Directive(s), it has to comply with the requirements of the relevant directive(s) in order to be CE marked and be placed on the EU market. CE marking is demonstrated via a declaration of conformity. Conformity with CE marking means conformity to the European Directive and not to the European Standards. But to be sure the product complies with the Directive; it is easier if it is made according to the harmonized standards referring to the Directive.

This process is ruled by the Global Approach and the New Approach.

In order to promote trade in goods between EU and candidate countries and EU and third countries by facilitating market access, Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) and Mutual Recognition Agreements (MRAs) have been negotiated respectively. They are bilateral agreements, and aim to benefit industry by providing easier access to conformity assessment procedures.

CE marking and the reality of SMEs

The CE marking of unique and made to measure products of low value (i.e. less than 50.000 euros) is uneconomic and does not contribute to consumer safety since the unique products are ordered on an already existing trust basis of proximity and personal contact. Thus the CE marking of these unique, made to measure products should not be compulsory, declaration of conformity by the manufacturer should suffice.

Simplified procedures for CE marking for small series production should be guaranteed through the accreditation and conformity assessment systems established under EU legislation. Public procurement should operate under these SME friendly rules.

The balanced representation of SME collective organizations in standardization technical committees and their right to vote in technical committees should be guaranteed by European Legislation on the standardization system.

Simplicity of standards written with the "Think Small First" principle should also be established in the European Legislation on the standardization system. Simplification manuals and training of SME standardization experts should be provided through European and National coordinated actions with sufficient funding


Certificate of Conformity

One important area where standardisation makes a decisive contribution to enforcement and control is that of certification. Certification is understood to mean that a neutral and independent body confirms the conformity of products to certain standards. The practical significance of certification is especially great in the areas of trade where standardisation plays a crucial role (electrical engineering). In the context of legal harmonization, the issuing of a certificate of conformity serves as proof that the product meets specific laws or other technical specifications and criteria.


Conformity Assessment

All conformity assessment activities are aimed at testing or proving that the product, process or service concerned complies with the essential legal requirements. The Global Approach was specified by the modular approach for the assessment of conformity with the new approach Directives. There are independent, indivisible and complementary modules. The modules are designated by the letters A to H. A conformity assessment procedure in the framework of the new approach Directives is necessary for the public authorities to ensure that products placed on the EU market conform to the essential requirements of the Directive(s) concerned. As the EU favours a free-market economy a broad choice between the modules must be left to the manufacturer. The Community legislator can choose between the different modules described. The complexity and stringency of the modules to be applied varies according to the risks associated with the product. When the valid directives not prescribe a procedure, the manufacture is then at liberty to choose the conformity assessment procedure himself. The most widely used is Module A.



- If the CE-marking is affixed on a product, this product is authorised to be placed freely on the market of the European Union. It is affixed on the product concerned itself or on the packaging by the manufacturer or his authorised agent. It does not have any fixed colour. If several Directives providing for the CE-marking apply to one and the same product, the application of the CE-marking indicates conformity with all applicable Directives. The CE-marking does not prohibit the application of other marks provided such marks are causing confusion with the CE-marking. The affixing of other markings intended to confuse third parties as to the meaning and form of the CE-marking must be prohibited.

14 steps to CE marking

1) Product Definition 2) Supplier Control. 3) Selection of relevant directives and standards. 4) Selection of a possible conformity assessment procedure. 5) Establishing contact with Notified Body. 6) Performance of the hazard analysis/risk assessment. 7) Verification that the demands from the Directives have been observed. 8) Provision of Information. 9) Preparation of technical documentation. 10) Examination and revision of the instruction handbook. 11) Drawing up the declaration of conformity. 12) CE marking. 13) Market access. 14) Series testing.


Declaration of Conformity

By means of a declaration of conformity, the manufacturer must demonstrate that his product complies with the essential health and safety requirements of the relevant EC directives. Prior to this the product may not be sold on the European internal market. The declaration of conformity is:

  1. a procedure in which the manufacturer or his authorized representative established in the Community declares that the product placed on the market complies with all the relevant safety requirements of the appropriated directive.
  2. a form that is to be supplied with every product and must be drawn up in the user's language.

CE marking is the declaration of conformity external proof, as the car insurance attestation shows the vehicle is insured although it is not the insurance contract



1. Which products need to be CE marked?

Only products falling under the scope of the New Approach Directives have to be CE marked.

2. Is there any harmonised standard supporting the CE marking?

The two main sources to find harmonised standards are the European Commission website and the New Approach website.

3. Where can I find a notified body to perform a conformity assessment?

NANDO IS (for all New Approach sectors but construction) and NANDO CPD (for construction products).

4. Is there a European Commission mandate on a certain product?

The following link gives access to a database of mandates, together with the access to their full text.



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