CE Marking
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area.
The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.
However, CE marking is a self-declaration. For this reason, when tendering a product as conforming to product safety requirements via a valid CE Declaration of Conformity, there must be no doubt that all of the necessary assessments have been made.
If however, you are found to be non-compliant with the your self declared CE mark, then there can be serious consequences to the product and manufacturer. If the product bearing a CE marking does not comply with the requirements of the Directives, measures will be taken to remove the device from the market and there will be EEA restrictions on the movement of the product.
In addition to this, there may also be:
- Prohibition of marketing
- Product recall
- Public warning issued
- Arrangement of thorough, 3rd party tests
In Germany the implementation of the New Approach directives is controlled by the state market supervisory authorities (Trade and occupational Safety Authorities), the accident insurance institutions and by the market (competitors, customers, consumer authorities) [1].
This results in the requirement for the manufacturer means that they must define and document the process and conduct thorough document management.
The RoHS Directive
The RoHS Directive 2011/65/EC refers to substance bans on electrical and electronic equipment. It contains a list of substances with limit values whose concentrations must not be exceeded. In particular, compliance of devices with the RoHS-II-Directive will in future be made clear by the CE-marking. [2]
Depending on the product type, further guidelines, such as the R&TTE-Directive or the Pressure Equipment Directive, may also have to be considered. Which directive is to be included in the CE Declaration of Conformity must be assessed from product to product according to its technical structure.
[1] CE marking of electrical equipment; (Chamber of Commerce Southern Upper Rhine, 2007)
[2] Leaflet ROHS II; (Chamber of Commerce and Industry for Munich and Upper Bavaria, 2013)
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Last update on 01.09.2019