Rob Beckert

Suggestion CE Marking

CE marking

The CE marking is a conformity marking mandatory for many products placed on the European market. The marking is a key indicator of a product’s compliance with EU legislation. By affixing the CE marking to a product, the manufacturer – on his sole responsibility – declares that it meets EU safety, health and environmental requirements.

Meaning

Existing in its present form since 1993, the CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area (EEA, the 27 Member States of the EU and EFTA countries Iceland, Norway, Liechtenstein). This also applies to products made in third countries which are sold in the EEA.

CE marking does not indicate that a product was made in the EEA, but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (e.g. safety, health, environmental protection requirements) of the applicable directive(s) – or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.

However, not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked. CE marked products are bought not only by professionals (e.g. medical devices, lifts, machinery and measuring equipment) but also by consumers (toys, PCs, mobile phones and light bulbs).

Countries requiring the CE marking

The CE marking is mandatory for certain product groups in the European Economic Area (EEA). It is also obligatory for all products made in third countries which are sold in the EEA. In that case, the importer has to make sure that the manufacturer outside the EU has taken the necessary steps that allow him to affix the CE marking.

Rules underlying CE marking

The manufacturer of a product himself affixes the CE marking to it, but has to take certain obligatory steps before his product can bear CE marking. He has to carry out a conformity assessment, set up a 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 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 then 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 that are 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 only be placed on the market 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 only bear additional markings under the condition that they do not overlap with the CE marking and are neither confusing and nor impairing the legibility and visibility of the CE marking

Characteristics of the CE marking

- The CE marking has to be affixed by the manufacturer or his authorized representative in the European Community according to its legal format visibly, legibly and indelibly to the product - The size of the CE marking must be at least 5 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 marking. This is done under the responsibility of the Notified Body.

Legal Implications

There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling CE marked products is the responsibility of public authorities in the Member States, in cooperation with the European Commission.Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected, or if a product’s safety is questioned. The procedures, measures and sanctions applying to counterfeiting of the CE marking vary according to the respective Member State's national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation, before being obliged to take the product off the market.

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