CE Marking Consultants – Specialists Advice and Certification
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
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:
· shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements
· is an indicator of a product’s compliance with EU legislation
· allows the free movement of products within the European market
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:
· carry out the conformity assessment
· set up the technical file
· issue the EC Declaration of Conformity (DoC)
· place CE marking on a product
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.
You can view the EC New Approach Directives guidance from the Europa website.
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:
· 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
The CE marking is not required for items, for example:
· cosmetics and foodstuffs
If you have an enquiry about the Construction Products Regulations or if you would like information on the new requirements for structural steel, which came into force on 1 July you can email firstname.lastname@example.org
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.
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, for example safety, are created 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 the essential safety requirements in detailed technical terms.
2. Check the product-specific requirements
It is up to you to ensure that your product complies with the essential requirements of the relevant EU legislation. The use of harmonised standards remains voluntary. You may decide to choose other ways to fulfil 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.
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 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.
UK conformity assessment bodies can no longer carry out mandatory conformity assessment for products being placed on the EU market.
4. Test the product and check its conformity
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.
5. Draw up and keep available the required technical documentation
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.
6. Placing the CE marking on your product and EC Declaration of Conformity
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:
· CE markings must only be placed by you - as the manufacturer - or your authorised representative
· the CE marking cannot be placed on 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 place any marking or sign that may misconstrue the meaning or form of the CE marking to third parties
· other markings placed on the product must not cover up the CE marking
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. You can read the CE marking regulations on the Europa website.
CE marking image rules
Depending on the specifics of the directive that covers your product, you must make sure that:
· the initials ‘CE’ are 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 is at least 5 millimetres - unless a larger minimum dimension is specified in the relevant directive
· the CE marking is placed onto 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 placed onto the packaging and accompanying documents
· the CE marking is easily visible, readable and permanent
Find example CE marking logos on the Europa website.
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 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:
· 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 if requested by an enforcement authority.
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 authorised representative within the EEA should:
· indicate that the product meets all the necessary requirements of the directives applicable to the specific product
· make sure it has the name and address of the manufacturer together with information about the product, for example brand and serial number
The DoC must be signed by an individual working for the manufacturer or his authorised representative, and indicate the employee’s function.
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:
· Trading Standards Services
· the Health and Safety Executive
· the Medicines and Healthcare products Regulatory 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.
The CE Marking Authority is guided by four principles: customer satisfaction rather than competitor focus, passion for innovation, commitment to operational excellence, and providing certification services that ensure our customers’ products are compliant.
Our revolutionary approach to CE & UKCA Marking Compliance is unique and speeds up the product certification process while maintaining a very high-quality service.
Using the Lean Six Sigma process, we have developed an accelerated product certification process.
We quickly establish the product legislation requirements and identify the mandatory product safety standards that are used to demonstrate compliance.
Our success is our customer’s success therefore we go above and beyond by supplying all the compliance documentation that is needed to demonstrate conformity with the applicable CE Marking Directives and UK Statutory Instruments in one folder so there is no need for you to worry about finding information on your systems, we even keep a copy of the folder on a dedicated password-protected hard drive in the event your folder goes missing.
Plus if you need an Authorized Representative in either region look no further we can sort that out. Giving our customers the complete package
If you require any assistance feel free to contact the team at The CE Marking Authority