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  • CE marking The CE mark, or formerly EC mark, is a mandatory

  • conformity marking for certain products sold within the European Economic Area since 1985.

  • The CE marking is found even on products sold outside the EEA, because they are either products

  • manufactured in the EEA and have been exported, or they were manufactured in other nations

  • which have EEA as a prime market. This makes the CE marking recognizable worldwide even

  • to people who are not familiar with the European Economic Area. It is similar then, in that

  • sense, to the FCC Declaration of Conformity used on certain electronic devices sold in

  • the United States. It consists of the CE-Logo and, if applicable,

  • the four digit identification number of the notified body involved in the conformity assessment

  • procedure. The CE marking is the manufacturer's declaration

  • that the product meets the requirements of the applicable EC directives.

  • The actual words signified by "CE" have been disputed. It is often taken to be an abbreviation

  • of Conformité Européenne, meaning "European Conformity". However, "CE" originally stood

  • for "Communauté Européenne", French for "European Community". In former German legislation,

  • the CE marking was called "EG-Zeichen" meaning "European Community mark". The CE marking

  • is a symbol of free marketability in the European Economic Area (Internal Market).

  • Meaning Existing in its present form since 1995, the

  • CE marking indicates the compliance with EU legislation of a product, wherever in the

  • world manufactured, and enables its free movement within the European market. By affixing the

  • CE marking on a product, a manufacturer is declaring, at its sole responsibility, conformity

  • with all of the legal requirements to achieve CE marking which allows free movement and

  • sale of the product throughout the European Economic Area. CE marking is intended for

  • national market surveillance and enforcement authorities.

  • CE marking signifies that the product conforms with all EC directives that apply to it. For

  • example, most electrical products must comply with the Low Voltage Directive and the EMC

  • Directive; electrical toys must also comply with the Toy Safety Directive. The marking

  • does not indicate usman manufacture. The manufacturer of CE-marked goods has verified that the product

  • complies with all applicable EC requirements, such as safety, health, and environmental

  • protection, and, if stipulated in any directive, has had them examined by a notified conformity

  • assessment body. Not all products need CE marking to be traded

  • in the EC; only product categories subject to relevant directives are required (and allowed)

  • to bear CE marking. Most CE-marked products can be placed on the market subject only to

  • an internal production control by the manufacturer (Module A; see Self-certification, below),

  • with no independent check of the conformity of the product with EU legislation; ANEC has

  • cautioned that, amongst other things, CE marking cannot be considered a "safety mark" for consumers.

  • CE marking is a self-certification scheme. Retailers sometimes refer to products as "CE

  • approved", but the mark does not actually signify approval. Certain categories of products

  • require type-testing by an independent body to ensure conformity with relevant technical

  • standards, but CE-marking in itself does not certify that this has been done.

  • Countries requiring the CE marking CE marking is mandatory for certain product

  • groups within the European Economic Area (EEA; the 28 member states of the EU plus EFTA countries

  • Iceland, Norway, Switzerland and Liechtenstein, plus Turkey). The manufacturer of products

  • made within the EEA and the importer of goods made in other countries must ensure that CE-marked

  • goods conform to standards. As of 2013 CE marking was not required by

  • countries of the Central European Free Trade Agreement (CEFTA), but members Republic of

  • Macedonia, Serbia, and Montenegro had applied for membership of the European Union, and

  • were adopting many of its standards within their legislation (as did most Central European

  • former member countries of CEFTA that joined the EU, before joining).

  • Rules underlying CE marking Responsibility for CE marking lies with whoever

  • puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer

  • or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer.

  • The manufacturer of a product affixes the CE marking to it but has to take certain obligatory

  • steps before the product can bear CE marking. The manufacturer must carry out a conformity

  • assessment, set up an electromagnetic comprehensiveness technical file and sign an EC declaration

  • of conformity. The documentation has to be made available to authorities on request.

  • Importers of products have to verify that the manufacturer outside the EU has undertaken

  • the necessary steps and that the documentation is available upon request. Importers should

  • also make sure that contact with the manufacturer can always be established.

  • Distributors must be able to demonstrate to national authorities that they have acted

  • with due care and they must have affirmation from the manufacturer or importer that the

  • necessary measures have been taken. If importers or distributors market the products

  • under their own name, they take over the manufacturer's responsibilities. In this case they must have

  • sufficient information on the design and production of the product, as they will be assuming the

  • legal responsibility when they affix the CE marking.

  • There are certain rules underlying the procedure to affix the marking:

  • Products subject to certain EC directives providing for CE marking have to be affixed

  • with the CE marking before they can be placed on the market.

  • Manufacturers have to check, on their sole responsibility, which EU directives they need

  • to apply for their products. The product may be placed on the market only

  • if it complies with the provisions of all applicable directives and if the conformity

  • assessment procedure has been carried out accordingly.

  • The manufacturer draws up an EC declaration of conformity and affixes the CE marking on

  • the product. If stipulated in the directive(s), an authorized

  • third party (Notified Body) must be involved in the conformity assessment procedure.

  • If the CE marking is affixed on a product, it can bear additional markings only if they

  • are of different significance, do not overlap with the CE marking and are not confusing

  • and do not impair the legibility and visibility of the CE marking.

  • Since achieving compliance can be very complex, CE-marking conformity assessment, provided

  • by a Notified Body, is of great importance throughout the entire CE-marking process,

  • from Design Verification, and set up of Technical File to the EC Declaration of Conformity.

  • Self-certification Depending on the level of risk of the product,

  • the CE marking is affixed to a product by the manufacturer or authorized representative

  • who decides whether the product meets all the CE marking requirements. If a product

  • has minimal risk, it can be self-certified where manufacturers a Declaration of Conformity

  • and affixes the CE marking to their own product. Manufacturer then must do several things:

  • Module A – Internal production control. Module B – EC type-examination.

  • Module C – Conformity to type. Module D – Production quality assurance.

  • Module E – Product quality assurance. Module F – Product verification.

  • Module G – Unit verification. Module H – Full quality assurance.

  • These will often ask questions about the product to classify the level of risk and then refer

  • to the "Conformity Assessment Procedures" chart. This shows all the acceptable options

  • available to a manufacturer to certify the product and affix the CE marking.

  • Products considered to have a greater risk have to be independently certified by a notified

  • body. This is an organization that has been nominated by a Member State and has been notified

  • by the European Commission. These notified bodies act as test labs and carry out the

  • steps as listed in the directives mentioned above and then decided whether the product

  • has passed. A manufacturer can choose its own notified body in any Member State of the

  • European Union but should be independent of the manufacturer and a private sector organization

  • or a government agency. In reality the self-certification process

  • consists of the following stages: Stage 1: Identify the applicable Directive(s)

  • The first step is to identify whether the product needs to bear CE marking or not. Not

  • all products are required to bear CE marking, only the products that fall within the scope

  • of at least one of the sectoral directives requiring CE marking. There are more than

  • 20 sectoral product directives requiring CE marking covering, but not limited to, products

  • such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless

  • devices and construction products. Identifying which directive(s) may be applicable,

  • as there may be more than one, involves a simple exercise of reading the scope of each

  • directive to establish which apply to the product (An example of the scope of the Low

  • Voltage Directive below). If the product does not fall within the scope of any of the sectoral

  • directives, then the product does not need to bear CE marking (and, indeed, must not

  • bear CE marking). Low Voltage Directive (2006/95/EC)

  • Article 1 states the Directive covers "any equipment designed for use with a voltage

  • rating of between 50 and 1000 V for A.C. and between 75 and 1500 V for D.C, other than

  • the equipment and phenomena listed in Annex II."

  • Stage 2: Identify the applicable requirements of the Directive(s)

  • Each Directive has slightly different methods of demonstrating conformity depending on the

  • classification of the product and its intended use. Every Directive has a number ofessential

  • requirementsthat the product has to meet before being placed on the market.

  • The best way to demonstrate that these essential requirements have been met is by meeting the

  • requirements of an applicableharmonised standard,’ which offer a presumption of

  • conformity to the essential requirements, although the use of standards usually remains

  • voluntary. Harmonised standards can be identified by searching theOfficial Journalon

  • the European Commission’s website, or by visiting the New Approach website established

  • by the European Commission and EFTA with the European Standardisation Organisations.

  • Stage 3: Identify an appropriate route to conformity

  • Although the process is always a self-declaration process,there are variousattestation routes

  • to conformity depending on the Directive and classification of the product. Some products

  • (such as invasive medical devices, or fire alarm and extinguisher systems) may, to some

  • extent, have a mandatory requirement for the involvement of an authorised third party or

  • "notified body". There are various attestation routes which

  • include: An assessment of the product by the manufacturer.

  • An assessment of the product by the manufacturer, with additional requirement for mandatory

  • factory production control audits to be carried out by a third party.

  • An assessment by a third party (e.g. EC type test), with the requirement for mandatory

  • factory production control audits to be carried out by a third party.

  • Stage 4: Assessment of the product's conformity When all of the requirements have been established,

  • the conformity of the product to the essential requirements of the Directive(s) needs to

  • be assessed. This usually involves assessment and/or testing, and may include an evaluation

  • of the conformity of the product to the harmonised standard(s) identified in step 2.

  • Stage 5: Compile the technical documentation Technical documentation, usually referred

  • to as the technical file, relating to the product or range of products needs to be compiled.

  • This information should cover every aspect relating to conformity and is likely to include

  • details of the design, development and manufacture of the product.

  • Technical documentation will usually include: Technical description

  • Drawings, circuit diagrams and photos Bill of materials

  • Specification and, where applicable, Declarations of Conformity for the critical components

  • and materials used Details of any design calculations

  • Test reports and/or assessments Instructions

  • EC Declaration of Conformity Technical documentation can be made available

  • in any format (i.e. paper or electronic) and must be held for a period of up to 10 years

  • after the manufacture of the last unit, and in most cases reside in the European Economic

  • Area (EEA). Stage 6: Make a Declaration and affix the

  • CE marking When the manufacturer, importer or authorised

  • representative is satisfied that their product conforms to the applicable Directives, an

  • EC Declaration of Conformity must be completed or, for partly completed machinery under the

  • Machinery Directive, an EC Declaration of Incorporation.

  • The requirements for the Declaration vary slightly, but will at least include:

  • Name and address of the manufacturer Details of the product (model, description

  • and the serial number where applicable) List of applicable sectoral Directives and

  • standards that have been applied A statement declaring that the product complies

  • with all of the relevant requirements Signature, name and position of the responsible

  • person The date that the Declaration was signed

  • Details of the authorised representative within the EEA (where applicable)

  • Additional Directive/standard specific requirements In all cases, except for the PPE Directive,

  • all of the Directives can be declared on one Declaration.

  • Once a Declaration of Conformity has been completed, the final step is to affix the

  • CE marking to the product. When this has been done, the CE marking requirements have been

  • met for the product to be placed legally on the EEA market.

  • Purpose for safety issues. Declaration of conformity

  • The DoC must include: manufacturer's details (name and address, etc.); essential characteristics

  • the product complies; any European standards and performance data; if relevant the identification

  • number of the Notified Body; and a legally binding signature on behalf of the organization.

  • Product groups The directives requiring CE marking affect

  • the following product groups: Active implantable medical devices

  • Appliances burning gaseous fuels Cableway installations designed to carry persons

  • Eco-design of energy related products Electromagnetic compatibility

  • Equipment and protective systems intended for use potentially explosive atmospheres

  • Explosives for civil uses Hot-water boilers

  • In vitro diagnostic medical devices Lifts

  • Low voltage Machinery

  • Measuring Instruments Medical devices

  • Noise emission in the environment Non-automatic weighing instruments

  • Personal protective equipment Pressure equipment

  • Pyrotechnics Radio and telecommunications terminal equipment

  • Recreational craft Safety of toys

  • Simple pressure vessels Restriction of the use of certain hazardous

  • substances RoHS 2 For a complete listing, see the New Approach

  • website established by the European Commission and EFTA with the European Standardisation

  • Organisations. Mutual recognition of conformity assessment

  • There are numerous 'Agreements on Mutual Recognition of Conformity Assessment' between the European

  • Union and other countries such as the USA, Japan, Canada, Australia, New Zealand and

  • Israel. Consequently, CE marking is now found on many products from these countries. Japan

  • has its own marking known as the Technical Conformity Mark.

  • Switzerland and Turkey (which are not members of the EEA) also require products to bear

  • CE marking as an affirmation of conformity. Characteristics of CE marking

  • The CE marking has to be affixed by the manufacturer or its authorized representative in the European

  • Union according to its legal format visibly, legibly and indelibly to the product

  • When a manufacturer puts the CE marking on a products this implies that he complies to

  • all the Essential Health and safety requirements from all the directives that applies to its

  • product. When the manufacturer of a machine puts the

  • CE marking, it engage himself and guarantee, that he makes all the tests, assessments and

  • evaluation on the product to conform all the requirements of ALL the directives that applies

  • to its product. CE marking has been introduced by the COUNCIL

  • DIRECTIVE 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels),

  • 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility),

  • 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic

  • weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC

  • (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC

  • (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment

  • designed for use within certain voltage limits) The size of the CE marking must be at least

  • mm, if enlarged its proportions have to be kept

  • If the appearance and workmanship of a product do not allow for the CE marking to be affixed

  • on the product itself, the marking has to be affixed to its packaging or accompanying

  • documents If a directive requires the involvement of

  • a Notified Body in the conformity assessment procedure, its identification number has to

  • be put behind the CE logo. This is done under the responsibility of the Notified Body.

  • The e mark On motor vehicles and related parts the UNECE

  • "e mark" or "E mark", rather than the CE logo, has to be used. Other than the CE logo, the

  • UNECE marks are not self-certified. They are not to be confused with the estimated sign

  • on food labels. Misuse

  • The European Commission is aware that CE marking, like any other mark, is misused. CE marking

  • is sometimes affixed to products that do not fulfill the requirements and conditions for

  • its affixing, or is affixed to products for which the affixing is not required. In one

  • case it was reported that "Chinese manufacturers were submitting well-engineered electrical

  • products to obtain conformity testing reports, but then removing non-essential components

  • in production to reduce costs". A test of 27 electrical chargers found that all the

  • eight legitimately branded with a reputable name met safety standards, but none of those

  • unbranded or with minor names did, despite bearing the mark; non-compliant devices were

  • actually potentially unreliable and dangerous, presenting electrical and fire hazards.

  • There are also cases in which the product complies with the applicable requirements,

  • but the form, dimensions, or proportions of the mark itself are not as specified in the

  • legislation. China Export

  • A very similar CE marking has been alleged to stand for China Export because some Chinese