CE marking

The CE marking certifies the conformity of the product with all applicable legislation in which it is intended to be affixed.

The CE marking is affixed to products placed on the market in the EEA and Turkey, whether they are manufactured in the EEA, Turkey or any other country.

The CE marking is the visible result of a whole process involving conformity assessment in a broad sense and indicates that a product is declared by its manufacturer to be in conformity with Union harmonization legislation.

The CE marking must be clearly visible, legible and permanently affixed to the product or its data label.

If a notified body is involved in the course of production monitoring/surveillance in accordance with applicable Union harmonization legislation, the identification number of the notified body must be followed by the CE marking.

Not all products must be CE marked. The obligation to affix the CE marking covers all products covered by directives which provide for this marking and are intended for the Union market.

However, even in Union harmonization legislation / directives, which generally provide for CE marking, certain products may be exempted from the CE marking:

• Incomplete machines, see Machinery Directive 2006/42/EC
• EX- components, see ATEX 2014/34/EU

The affixing of the CE marking to a product which is not covered by any Union harmonization legislation containing provisions for affixing it shall be considered misleading, since consumers or users may can be given the impression that the product concerned complies with certain Union harmonization legislation.

A product is considered safe under Article 3 of Directive 2001/95/EC if the manufacturer complies with the health and safety requirements of the Member State in whose territory the product is marketed.

The Directive contains general safety requirements, provisions on market surveillance, notification procedures for the disclosure of unsafe products and obligations of market participants.

For these products there is no CE marking.

A product undergoes a conformity assessment at both the design and manufacturing stages. Responsible for the conformity assessment is the manufacturer. This is the case even if a manufacturer assigns the design or the manufacturing to a subcontractor.

There are eight modules (marked with the letters A to H). They shall specify the obligations of the manufacturer (and his authorized representative) and the degree of involvement of the accredited internal or notified conformity assessment body. They are the “horizontal” components of the conformity assessment procedures laid down in Decision No 768/2008/EC.

The following guidelines (with a few exceptions) trigger a CE marking requirement:

• Low Voltage Directive 2014/35/EU
• Machinery Directive 2006/42/EC
• ATEX Directive 2014/34/EU
• EMC Directive 2014/30/EU
• PED 2014/68/EU
• Simple PED 2014/29/EU

By the way: EU directives are indirect law and must be nationalized.

Example: The Product Safety Act (ProdSG) in Germany regulates the safety requirements of technical equipment and consumer products.

Germany: In general, a distinction must be made between product liability (ProdHaftG) and producer liability (§823 BGB). Both are applicable side by side in parallel, i. the injured person can rely on both claims, whereby he only gets money once. In the event of personal injury, the maximum liability amount (§11 ProdHaftG) – also for several affected persons – is € 85 million.

Authorities can punish violations – whether deliberate or negligent –as administrative offense with fines (example: Missing CE mark up to 50,000 euros)

In addition, public authorities can take measures to protect consumers, which can lead to further significant financial consequences for the manufacturer. The range of official measures ranges from the mere warning to the recall and sales ban.