CE marking
The CE marking is a mark of conformity used in the European Union (EU) to indicate that a product complies with applicable EU directives and regulations. Its purpose is to ensure the safety of products for consumers and to enable the free movement of goods within the EU internal market. The CE marking is affixed to the product by the manufacturer and shows that the product meets essential health, safety and environmental requirements. It is the manufacturer's responsibility to create the necessary technical documentation and ensure that the product conforms to EU directives before it is placed on the market.
The sub-steps of the CE marking are briefly explained below.
01
Directive research
The directive research is at the beginning of the CE marking process. The manufacturer of a product must determine which directives apply to his product. The requirements noted in the respective guidelines indicate the respective safety standard that a manufacturer must comply with.
02
Standards research
The measures and regulations to be observed for a product to ensure safety are not only stipulated by the EU directives. The regulations in guidelines are formulated in general terms. In addition, product-related requirements are formulated in standards. These are formulated more specifically and are often adapted to specific products.
In order to achieve the conformity of a product with an EU directive, so-called "harmonized standards" must be applied. The standards harmonized with the directives can be found in official gazettes published by the European Union.
The most important Internet address for researching standards is www.beuth.de. All European and international standards are marketed by Beuth-Verlag.
03
Risk assessment
The Machinery Directive and the Pressure Equipment Directive both require a risk assessment to be carried out. The risk assessment ensures that the safety and health protection requirements of a product are met.
The risk assessment must be documented. The records of the risk assessment are the most important document to prove to the legislator that a product complies with the applicable regulations and meets the necessary safety requirements.
The most important set of rules for carrying out a risk assessment is EN ISO 12100.
04
Assess conformity
When a product, a process or a technical system meets requirements that are specified by law, this compliance is referred to as conformity.
The responsibility for the conformity assessment of a product always lies with the manufacturer. The manufacturer is the legal or natural person who manufactures or develops the product or places it on the market under his name.
The involvement of a Notified Body is mandatory in some cases, especially for products with a high risk potential (e.g. pressure equipment category III or IV) or for certain directives that require it.
The different directives (Machinery Directive, Pressure Equipment Directive, etc.) each contain specifications on how the conformity procedure is to be carried out.
05
Technical documents
According to the German Civil Code (BGB) and the Product Liability Act (ProdHaftG), fines and penalties can be imposed for incorrect and non-compliant technical documents if a case of damage occurs at the same time.
A rough distinction can be made between internal technical documentation, such as development and construction plans or risk assessment, and external technical documentation, such as operating instructions, service manuals or identification of residual risks.
