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What Is CE Marking

Introduction

The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA), consisting of the 27 member states of the EU and European Free Trade Association countries Iceland, Liechtenstein and Norway. The CE marking is required for many products and attests the verification by a manufacturer that these products meet EU safety, health or environmental requirements.

This guide provides an introduction to CE marking and the various situations in which it applies. You can also find information about what products CE marking applies to, how to use it successfully and how to ensure that you comply with all relevant regulations.

As a manufacturer, this will lead you through the process of affixing the CE marking to your specific product, by clearly illustrating the key steps to undertake from the beginning to the trading of the product. If you are a distributor or importer you will have to know the requirements that the products you are importing or distributing must meet to be traded freely within the EEA.

A product’s compliance with EU legislation

CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing 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 and therefore ensuring validity for that product to be sold throughout the EEA, the 27 member states of the EU and European Free Trade Association countries - Iceland, Norway, Liechtenstein and Turkey. This also applies to products made in third countries which are sold in the EEA and Turkey. However, 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 indicate that a product was made in the EEA, but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements, eg a harmonised level of safety, to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements, eg health and safety requirements, of the applicable directive(s) or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.

It is the manufacturer’s responsibility to:

Distributors must verify the presence of both the CE marking and the necessary supporting documentation. If the product is being imported from a third country, the importer has to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request.

How to place a CE marking on a product

Before you affix a CE marking to 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.

1. Identify the directive(s) and harmonised standards applicable to the product

There are more than 20 directives setting out the product categories requiring CE marking. The essential requirements that products have to fulfil, eg safety, are harmonised at EU level and are set out in general terms in these directives. Harmonised European standards are issued with reference to the applied directives and express in detailed technical terms the essential requirements.

2. Verify the product-specific requirements

It is up to you to ensure that your product complies with the essential requirements of the relevant EU legislation. Full compliance of a product to the harmonised standards gives a product the presumption of conformity with the relevant essential requirements. The use of harmonised standards remains voluntary. You may decide to choose other ways to fulfil these essential requirements.

3. Identify whether an independent conformity assessment is required from a Notified Body

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 indeed required. These Bodies are authorised by national authorities and officially ‘notified’ to the European Commission and listed in the NANDO (New Approach Notified and Designated Organisations) database.

4. Test the product and check its conformity

Testing the product and checking its conformity to the EU legislation (Conformity Assessment Procedure) is the responsibility of the manufacturer. 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.

5. Draw up and keep available the required technical documentation

The manufacturer has 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. Together with the EC DoC, the technical documentation must be presented on request to the relevant national authorities.

6. Affixation of the CE marking to your product and EC Declaration of Conformity

The CE marking must be affixed by the manufacturer, or by his authorised representative within the EEA or Turkey. It must be affixed according to its legal format visibly, legibly and indelibly to the product or its data plate. 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.

Reproduce 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 affixed to 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. However, the following general provisions all apply:

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.

Reproduce the CE marking

There are a number of factors that you must conform to when reproducing the CE marking image on your product - some will depend on the specifics of the Directive that covers your product. The factors state that:

CE marking enforcement and documentation

There are a number of 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.

Keep documentation for CE marking

Please refer to the specific Directives and/or Regulations, and also our guidance documents.

You must keep certain documentation once you have affixed the CE marking to your product. This information can be requested at any time by the Market Surveillance Authorities to check that a CE marking has been legitimately affixed to a product.

The information you must retain will vary depending on the specific directives relevant to your product. However, you must keep general records of:

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