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.
Products that need CE marking
CE marking is mandatory, but only for those products which are covered by the scope of one or more of the New Approach Directives.
Even if your product is manufactured outside the EEA, you must ensure the product bears CE marking if your product comes under the scope of a directive requiring CE Marking. Not all products sold in the EU need to bear CE marking.
CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The full list of these product categories is below:
The CE marking is not required for items, for example:
How to place a CE marking on a product
Before you place a CE marking on a product, you need to establish which EU New Approach Directives apply to your product. You must not attach a CE marking to a product outside the scope of the directives.
The process you follow depends on the directives that apply to your product.
There are more than 20 directives setting out the product categories requiring CE marking. The essential requirements that products have to fulfil, for example safety, are created at EU level and are set out in general terms in these directives. Harmonized European standards are issued with reference to the applied directives and express the essential safety requirements in detailed technical terms.
It is up to you to ensure that your product complies with the essential requirements of the relevant EU legislation. The use of harmonized standards remains voluntary. You may decide to choose other ways to fulfill these essential requirements. If you don’t follow the safety requirements of a standard as it is written you will need to show that your product is as safe, by presenting the relevant documentation.
Each directive covering your product specifies whether an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking. This is not obligatory for all products, so it is important to check whether the involvement of a Notified Body is required. These bodies are authorised by national authorities and officially ‘notified’ to the European Commission and listed on the NANDO (New Approach Notified and Designated Organisations) database.
If you manufacture a product it is your responsibility to test the product and check its conformity to the EU legislation (conformity assessment procedure). One part of the procedure is, as a general rule, a risk assessment. By applying the relevant harmonised European standards, you will be able to fulfil the essential legislative requirements of the directives.
If you manufacture a product you need to establish the technical documentation required by the directive(s) for the assessment of the product’s conformity to the relevant requirements, and for the risk assessment. You must be able to present the technical documentation and EC DoC to the relevant national authorities, if requested.
The CE marking must be placed on the product by the manufacturer, or by his authorised representative within the EEA or Turkey. It must be placed according to its legal format to the product or its data plate. It must be visible, legible and impossible to remove. If a Notified Body was involved in the production control phase, its identification number must also be displayed. It is the manufacturer’s responsibility to draw up and sign an ‘EC DoC’ proving that the product meets the requirements. That’s it, your CE-marked product is ready for the market.
Using the CE marking
Once you have satisfied the conformity assessment requirements for CE marking you must attach the CE marking to your product or its packaging. There are specific rules for using the CE marking for your product, as well as rules for the reproduction of the CE marking logo.
In general you should attach the CE marking to the product itself but it may also be placed on the packaging, in manuals and on other supporting literature. Rules covering the use of the CE markings vary depending on the specific EU directive that applies to the product and it is advisable to study the applicable guidance. The following general rules all apply:
Member states will ensure they implement the regime governing the CE marking. They will take appropriate action in the event of improper use of the marking and provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties will be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
The general principles of the CE marking are contained within Regulation (EC) No 765/2008 which sets the requirements for accreditation and market surveillance relating to the marketing of products.
CE marking image rules
Depending on the specifics of the directive that covers your product, you must make sure that:
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:
The manufacturer’s Declaration of Conformity
The EC DoC is a document which may be required to accompany a product. In the document the manufacturer, or his authorized representative within the EEA should:
CE marking enforcement
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.