Your complete guide to the most common terms in CE marking

CE marking is mandatory for allowing access to the European Union. CE stands for “Conformité Européenne”, which in practice means “conforms to European directives”. CE marking of a product means that it complies with the legal requirements placed on the product within the European Economic Area (EEA) and therefore can be sold there. 

This compiled list gives you a complete introduction to CE-marking by outlining the most common terms used in connection with the certification.

Read more: How can Nemko help you obtain ce mark certification.

CE identification number
This is a four digit identification number of the Notified Body that appears on the label if there are requirements for the involvement of a Notified Body in the CE marking process.

EU Declaration of Conformity (EU DoC)
Document in which the manufacturer declares that their product conforms to the current directives and standards in the European Union (EU). It also need to state that a technical construction file is complete and available. The EU DoC will need to be prepared and signed before a company can affix the CE mark on a product.

Directives
Directives are high-level legal acts that are made into national laws. Although there are hundreds of directives overall, there are only a few directives that are relevant for a given product. Relevant directives may cover areas such as electrical safety, energy or EMC compliance, and may also cover special product categories. The latter is typically for product categories regarded as having high risk, such as medical equipment or machinery. Directives are, however, often quite short and very general, making them hard to demonstrate. For instance, the Low Voltage Directive states that a product is to protect the “health and safety of persons, of domestic animals and property.” Standards, in contrast, are specific and detailed.

Economic operators
There are four economic operators, and they have distinct and sometimes overlapping roles and responsibilities;

1. The manufacturer manufactures a product, or has a product designed, and markets that product under their name or trademark or uses it for their own purposes. A manufacturer will in practice be responsible for producing all technical documentation
   as specified in the directives and also be the one to sign the EU Declaration of Conformity.
2. An authorised representative is established within the EU and has received a written mandate from a manufacturer to act on their behalf in relation to specified tasks.
3. An importer is a person or company (legal entity) placing an outside product on the EU market. It is the responsibility of the importer that the product they import and sell is compliant with all relevant directives. They must verify that the manufacturer has fulfilled their obligations towards conformity assessment. If an importer imports a product and market it under a new brand name, it will give the importer the responsibilities as if they were the manufacturer.
4. The distributor neither manufactures nor imports the product, but is part of the supply chain, making the product available on the market.