If you wish to place a product on the European Market you must review all of the CE Marking Directives scope to see if your product requires CE Marking. If your product falls under the scope of a Directive, the Directive must be applied (this frequently means multiple Directives need to be applied.
Each Directive can be complied with by applying the appropriate Standards. Some Directives can be addressed by self certification, others (normally where the risk is high) require the use of a Notified Body and may require Quality System Audits.
There are literally thousands of CE Marking Standards and it is imperative that you select the correct ones for your product and market. Some standards are ‘product’ specific others are location specific and generic.
Standards change frequently and you must keep re-addressing the requirements of Standards when they change and updating your Declaration accordingly. The following information is derived from UK Government and European legal sources.
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.
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 (or their legal representative) responsibility to:
- Carry out the conformity assessment
- Set up the technical file
- Issue the EC Declaration of Conformity (DoC)
- Affix CE marking on a product
- Monitor Legislation/Standards for changes
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.
Products that need CE marking
CE marking ensures the free movement of products that conform to the legislation – eg safety, health and environmental protection – within the European market and is a key indicator of a product’s compliance with EU legislation. 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.
Products that need a 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. Such products fall under one or more Directives which determine the specific requirements that the product must meet in order to be CE marked. The full list of these product categories is below:
- active implantable medical devices
- appliances burning gaseous fuels
- cableway installations designed to carry persons
- eco-design of energy related products
- electromagnetic compatibility
- equipment and protective systems intended for use in potentially explosive atmospheres
- explosives for civil uses
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- low voltage
- measuring instruments
- medical devices
- noise emission in the environment
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- radio and telecommunications terminal equipment
- recreational craft
- safety of toys
- simple pressure vessels
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.
The process you follow depends on the Directives that apply to your product.
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:
- CE markings must only be affixed by you – as the manufacturer – or your authorised representative
- the CE marking cannot be affixed to products which are not covered by the relevant European Directives.
- when attaching the CE marking, you take full responsibility for your product’s conformity with the requirements of the relevant directives
- you must only use the CE marking to show the product’s conformity with the relevant directives
- you must not affix any marking or sign that may misconstrue the meaning or form of the CE marking to third parties
- other markings affixed to the product must not cover up the CE marking
- member states shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking; they shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements – those penalties shall 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. You can read the CE marking regulations on the Europa website.
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:
- the CE marking must consist of the initials ‘CE’ in the standard, recognisable form
- if you reduce or enlarge the size of your marking, the letters CE must be in proportion to the standard version
- the CE marking must be at least 5 millimetres – unless a larger minimum dimension is specified in the relevant Directive
- you must affix the CE marking to the product or to its data plate – if this is not possible or not warranted because of the nature of the product, it must be affixed to the packaging and accompanying documents
- the CE marking must be easily visible, readable and permanent
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:
- Trading Standards Services
- the Health & Safety Executive
- the Medicines and Healthcare products Regulatory Agency
- the Vehicle Certification Agency
- the National Measurement Office
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:
- how the product is manufactured
- how the product conforms to the relevant national standards
- addresses of manufacture and storage places
- design and manufacture of the product
- which New Approach Directives apply to the product and how they have been met
- European Community type-examination certificates, if applicable
You should keep the information in the form of a technical file which can be supplied upon request by an enforcement authority.
The manufacturer’s Declaration of Conformity
The EC DoC is a document which may be required to accompany a product and in which the manufacturer, or his authorised representative within the EEA, indicates that the product meets all the necessary requirements of the directives applicable to the specific product. The DoC shall also contain name and address of the manufacturer together with information about the product, such as brand and serial number. The DoC must be signed by an individual working for the manufacturer or his authorised representative, and the employee’s function shall also be indicated.
|Common Directives||Basic Scope|
|Equipment For Potentially
Notified Bodies Commonly Involved in testing (CAT 0,1 electrical, 0 non-electrical)
|Electrical and mechanical equipment for use on the surface, below ground or on fixed offshore installations where potentially explosive atmospheres may occur.|
Normally Self Certification
|‘Functioning machines’, that is assemblies of mechanically linked parts, at least one of which moves.|
|The Low Voltage Directive
Normally Self Certification
|Most electrical equipment that is designed for use with a voltage rating of between 50 and 1000 volts (alternating current) and between 75 and 1500 volts (direct current).|
|The EMC Directive
Normally Self Certification (with possible use of external test house)
|Relate to the non-generation of electromagnetic disturbance and immunity from such disturbance.
Recently updated to cover 3Ghz
|The Pressure Equipment
Notified Bodies Commonly Involved
|Pressure equipment and assemblies subject to an internal pressure greater than 0.5 bar. Concerns manufacturers of items such as shell and water tube boilers, heat exchangers, vessels, pressurised storage containers, industrial pipe work and pressure accessories.|