CE Marking refers to the process through which the manufacturer/importer informs users and the competent authorities that the device being sold complies with the essential requirements established by mandatory legislation.

When a product is covered by more than one directive carrying the CE Marking, this indicates that the product complies with the requirements contained in all applicable directives.

However, in cases where one or several directives, during a transitory period, allow the manufacturer to choose whether to apply them or not (in which case they must comply with the national legislation in force), the CE Marking will solely refer to compliance with the regulations of the directives that have been applied. The documentation resulting from the conformity assessment procedures should therefore only include reference to these directives.

Conformity Marking

The Conformity Marking is depicted by the initials "CE", represented as follows:

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• The proportions should be maintained, with the vertical dimension measuring no less than 5 mm.

• It should be affixed to the product or its data plate. If this is not possible, it should appear on the packaging, where available, and on the accompanying documentation, if stated in the directive.

• It must be visible, legible and indelible.

• It must be followed by the identification number/s for the relevant Notified Body/ies.

• It is the only marking that indicates that the product complies with the applicable directives.

• It should be affixed at the end of the production control phase.

• It should be affixed by the manufacturer or their authorised representative within the European Union. In exceptional cases, and when permitted by the directive, it can be affixed by the person responsible for putting the product on the market in the European Union.

• It is illegal to affix other symbols which could be confused with the CE Marking, either in meaning or appearance. A product can carry other markings or stamps, as long as they are not easily confused with the CE Marking and do not adversely affect its legibility or visibility. Manufacturers whose brand symbols may be confused with the CE Marking are authorised to keep their brand for 10 years following adoption of the regulation provided that the brand was registered prior to 30/06/89 and is currently in service.