The CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 28 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA.
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA).
The CE marking is required for many products. It:
By placing the CE marking on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking. The manufacturer is thus ensuring validity for that product to be sold throughout the EEA. This also applies to products made in third countries which are sold in the EEA and Turkey.
Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.
CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.
If you are a manufacturer it is your responsibility to:
If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.
If you are importing a product that is from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available.
Please refer to the specific directives and/or regulations, and also our guidance documents. You must keep certain documentation once you have placed the CE marking onto your product. This information can be requested at any time by the Market Surveillance Authorities to check that a CE marking has been legitimately placed on a product.
The information you must keep will vary depending on the specific directives relevant to your product. You must keep general records of:
You should keep the information in the form of a technical file which can be supplied if requested by an enforcement authority.
The EC DoC is a document which may be required to accompany a product. In the document the manufacturer, or his authorised representative within the EEA should:
The DoC must be signed by an individual working for the manufacturer or his authorised representative, and indicate the employee’s function.
There are many bodies that enforce CE marking legislation to prevent misuse of the CE marking and to ensure that product safety is maintained to a high standard.
Enforcement, or market surveillance, is undertaken by nominated public authorities (Market Surveillance Authorities) in each member state, and each state has separate ways of enforcing the legislation once it has been implemented into national law.
Market Surveillance Authorities and processes will vary depending on which directives are applicable to your product. The following bodies, amongst others, are responsible for CE marking enforcement in the UK:
If an enforcement body finds your product does not meet CE marking requirements, they will often provide you with an opportunity to ensure it is correctly CE marked. If you fail to comply with this, you will be obliged to take your product off the market. You may also be liable for a fine and imprisonment.