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 of ‘essential

requirements’ that 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 applicable ‘harmonised 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 the ‘Official Journal’ on

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 various ‘attestation 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