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 marking
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 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.
There are four economic operators, and they have distinct and sometimes overlapping roles and responsibilities;
- 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.
- 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.
- 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.
- The distributor neither manufactures nor imports the product, but is part of the supply chain, making the product available on the market.
Harmonised standards / EN standards (Please also see Standards)
Harmonising a standard means that all member states in EU accept the standard as an aid to compliance with the requirements in the directives. Harmonised standards for the entire EU are published to help manufacturers and import agents meet product requirements.
The harmonised standards are characterised by the letters EN before the standard number, and by their being listed under a product directive and published in the Official Journal. If the product is designed, manufactured and tested in accordance with the harmonised EU standard, it is considered as being in compliance with the requirements in the directive(s). These EN standards give a “presumption of conformity”, which means that if you comply with all the requirements in the EN standards, you are presumed to comply with the requirements in the corresponding EU directive.
Nando (New Approach Notified and Designated Organisations) is a European Commission database where you can search for all the notified bodies. You can read more about Nando and search the database for Notified Bodies here.
The New Approach
The New Approach directives refer to standards for technical requirements. The directives required for CE marking follow this model.
A Notified Body is an organisation designated by an EU country to assess the conformity of certain products before they are placed on the market. Notified bodies carry out tasks related to conformity assessment procedures when a third party is required. The European Commission publishes a list of notified bodies. For some EU directives, it is mandatory to use a Notified Body during the compliance process to meet the requirements.
All harmonised standards are published in the official journal of the European Union.
As directives are often quite general when setting goals, they refer to standards. These standards can either be product-specific, such as the safety standard for an electric toaster, or be general, covering for instance protection against water. The latter standards are often called “horizontal standards” as they are valid for all product categories. The standards set very detailed technical requirements and one standard may easily fill more than 100 pages. A standard requires technical competence to understand, and the tests described in a standard often require a specially equipped laboratory.
Technical construction file
CE marking is not a proof of compliance; it is the technical construction file behind the product that is the actual proof of compliance. The purpose of the technical construction file is to describe the product and to document the design and any analysis, including testing. A few examples of content in a technical construction file could be; photos or illustrations showing external features and marking, test reports, versions of software and firmware affecting compliance, user information, manufacturing drawings and schematics, installations instructions ++.
Third-party certification means that a Notified Body confirms that a product fulfils a particular technical specification, such as requirements for CE marking of an electrical or electronic product. Third-party certification is an ongoing quality assurance for the product owner and the market. Third-party marking can be used as proof of quality, demonstrating that CE requirements have been fulfilled for the product.