General

            One of the main aims for the European Union is to move to a single market, without trade barriers. Products complying with essential requirements concerning safety, health and environment, are permitted on that market without restrictions.

            Products that comply with the essential requirements shall be provided with the CE marking by the manufacturer. Products with the CE marking have free access to all member states.

            The member states of the European Union (EU) and of Iceland, Lichtenstein and Norway cooperate on this in the "European Economical Area - EEA" and are implementing EU-Directives in their laws. The EU-Directives are based on the principles of the "New Approach" and the "Global Approach".

New Approach

            The basic principles of this approach are:

• obligations are limited to essential requirements concerning safety, health and environment; the wording chosen for these requirements is extremely general and suitable for flexible interpretation,

• special bodies are charged with the issue of harmonized standards with technical requirements; the standards are based on international standards and specify in detail how essential requirements can be complied with,

• products which comply with harmonized standards are assumed to comply with the essential requirements,

• the use of harmonized standards is voluntary; the standards specify one way of compliance with the essential requirements, there may be alternative ways; manufacturers may use alternative ways to demonstrate compliance with essential requirements.

Global Approach

            Conformity assessment procedures are harmonized into a modular scheme (see page 3) specifying obligations for Manufacturers and Notified Bodies. Modules A to H apply, depending on the directive(s) and the type of product in question.

            Individual directives do not refer to the modular scheme directly but contain a specification of the applicable conformity assessment procedures. Usually the modules can be clearly recognized.

            The scheme is set up in order to reduce the involvement of public authorities in the procedures for verification of compliance with the requirements. With products where this is considered unavoidable, due to the related risks, a Notified Body must be involved.

            The role of the public authorities in the member states is limited to market-surveillance and surveillance of the activities of Notified Bodies. The market-surveillance consists of removal of products without the CE marking, and random control of products with the CE marking. In case of accidents the public authorities are always involved.

Manufacturers Obligations

            The conformity assessment modules specify the manufacturers obligations in the design- and production-stage of the products with the CE marking. The responsibility for observing all these obligations lies with the party that actually enters the market with the product(s).

            Manufacturers outside EU- and EFTA- countries will need an importer, in one of the EU-countries, prepared to bear the responsibilities. An importer will only be prepared to take on these responsibilities, if the manufacturer can convince him, and provide evidence, that all requirements are complied with.

            Importers without any influence on the design or production of the products, will request that Technical Construction Files and Declarations of Conformity are drawn up by the actual manufacturer and that the quality system that generates these documents is reliable.

            In the case of a unique product, for one customer only, there may not be an intermediate importer. The customer then bears similar responsibilities as the importer. Direct customers and importers with responsibilities concerning CE marking shall be legal entities or persons within one of the EU- or EFTA-member-state countries.

            All modules require that manufacturers prepare:

• technical construction files, that contain evidence that the designs of the constructions comply with the essential requirements,

• declarations of conformity, for each individual produced product with the CE marking, stating that the product is in accordance with the technical construction file.

Separate information leaflets are available for Technical Construction Files and Declarations of Conformity.

CE marking

            The CE marking consists of the letters C and E, for "Conformité Européenne", with dimensions, and shaped, in accordance with the relevant directive.

            The letter-height shall be at least 5mm and the dimensions shall be as pictured in the following figure. The marking shall appear near the name of the manufacturer and the type- and series-designation of the product. The marking shall be clearly legible and indelible.

            Adjacent to the CE marking, the assignment-number of the Notified Body shall be indicated if the Notified Body was mandatorily involved in the conformity assessment procedure in the production phase.

            The actual meaning of the CE marking is: a declaration of the manufacturer, that the product complies with the essential requirements of applicable EU-Directives.

            As such, the CE marking is not equivalent with traditional certification marks:

• the CE marking does not indicate whether, or which, standards were used to demonstrate compliance with essential requirements,

• the activities of manufacturers are not regularly monitored in case the directives do not require the intervention of a Notified Body in the production stage.

Products and Directives

            Many products may be covered by only one single EU-directive, or may fall under the scope of more than one directive. It is therefore important to know the scope of each of the directives, because the essential requirements of all applicable directives must be complied with.

            Unique components of electrical equipment, without any other application, need not be provided with the CE marking; the marking shall appear on the appliance with that component. For components for general use (e.g. wire and cable, switches, thermostats, etc.) it is advised to follow the CE marking procedures.

Notified Body

            The safety risk associated with certain product-types can be such that an independent body must be involved in the conformity assessment procedures. Each member-state notifies the European Union about suitable bodies, within its own territory: "Notified Bodies". Certain directives indicate similar bodies as "Designated Laboratory" or "Competent Body".

            Assignments to Notified Body can be obtained only by institutes that demonstrate reliability, independence and professional knowledge.

            Although Module A does not require the involvement of a Notified Body, manufacturers may still wish to use the test-equipment, the experience of the engineers and the independence of judgement of a Notified Body. Technical Construction Files and Declarations of Conformity which are supported by a Notified Body will be of value in case of a dispute.

Harmonized technical standards

            The following bodies are charged with the harmonization and issue of technical standards:

• ETSI, for telecommunication equipment

• CENELEC, for electrical equipment, excluding telecommunication equipment,

• CEN, for all equipment, excluding electrical equipment.

            Standards are issued as EN-standards and published in official journals. Whenever possible EN-standards are based on ISO- or IEC-standards.

            The standardization-bodies coordinate and administrate the work of technical committees for individual standards. Committee-members are representatives of standardization-institutes of member-states, certification institutes, consumers and industry.

CEBEC

            CEBEC provides CE-services through an international network of independent certification offices. CEBEC holds relevant assignments for the following Directives:

            The assignment-number of CEBEC as a Notified Body is: 0649

Information

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CEBEC provides market access