If you are new to the field of CE marking and are looking for some information to explain the basics, this page is a good place to start. Our website contains significant amounts of information about CE marking and some of it is necessarily detailed.
On our site you will find information on the CE marking process, background history, specific information about each CE marking directive (and some non-CE marking directives), the administrative requirements, testing requirements and much more. Use this page to learn the fundamentals of CE marking and when you are ready to learn more on the subject you are interested in, try looking at our detailed information pages.
Frequently Asked Questions
What is CE marking?
"CE marking" is a process that applies to a wide variety of products and one which manufacturers located in the EU or importers of goods into the EU must complete. The CE mark is affixed to the product as the final stage of this process and is effectively a statement from the manufacturer (or importer) that the process has been successfully completed and that the product meets the essential requirements of the relevant CE marking Directives.
Introduction to CE Marking
What products need CE marking?
Most of them! If the product falls within the scope of at least one of the CE marking directives and is not specifically excluded, it must be CE marked. Because the directives cover such a large range of products it is not practical (or possible!) to write a list of all the included and excluded products here. However, if you follow the flowchart below you should get an understanding of the directives you need to be dealing with. Once you have identified the ones of interest, you can find out more about them on our detailed directives pages.
The flowchart below illustrates the main safety directives. Click to view or download the flowchart as a PDF file with clickable links to more detailed information.
Is CE marking compulsory?
If the product falls under at least one of the CE marking directives, yes. The penalties for not correctly CE marking a product, falsely CE marking a product or failing to CE mark a product for which it is required are generally a maximum of 3 months in jail and a £5000 fine (for the director of the offending company).
What does CE marking involve?
Basically, designing a product to meet the relevant standards, creating a Technical File and producing a Declaration of Conformity.
What you really need to do is to demonstrate that you have fulfilled the essential requirements of any relevant directives. These are in two parts; Protection requirements and Administrative requirements. The protection requirements relate to the design of the product and can be demonstrated by meeting the requirements of the relevant harmonised standards. The administrative requirements relate to how the product is CE marked. This generally involves the manufacturer producing a Declaration of Conformity and a technical file containing design/manufacturing information and also the application of the CE mark to the product.
The flowchart below outlines the basic steps of the process. Click image to see full size:
What is the point of CE marking?
The principal point of CE marking is to provide a ‘level playing field’ of market requirements across the European Community. Effectively, this removes barriers to trade throughout the European Economic Area, allowing companies free access to markets in all the different countries without having to meet particular local requirements. The method of achieving this level playing field is to provide product safety requirements.
When did CE marking come into effect?
The European Single Market was created at the beginning of 1992, with the objective of removing barriers to trade throughout the European Economic Area. In the period up to 1992, and subsequently, the European Parliament has enacted a series of measures intended to put the Single Market into practice. Some of these Directives, the "New Approach Directives", specify controls on product design and documentation and include the requirement to affix the CE mark. Full details of the creation and implementation dates for each CE marking directive can be found on our Directives pages.
What are the directives? Where do standards fit in?
The CE marking Directives are documents published by the European Commission that lay out the protection requirements (design safety) and the administrative requirements for products intended to be manufactured or imported into the EU. There are many Directives, covering a large range of products, but they all essentially contain these two distinct sets of requirements. However, the directives do not state how the requirements are to be specifically and quantifiably achieved. This task is left to each individual EU member state to implement into their own national laws. This, in turn, is the role of the standards.
Various multinational committees meet to produce and update standards relating the safety, marking, design etc of products within their fields. These standards are implemented at national, European or international level and some are ultimately adopted by the member state governments to specify the requirements of the Directives. When a standard has been referenced by the European Commission (by publication in the Official Journal of the EU), it can be adopted by a member state as a yardstick to use for product compliance. The process of producing a standard which specifies the essential requirements of a Directive is known as harmonisation. In this situation a product which complies with the approved standards for a given Directive can be presumed to comply with the essential requirements of the Directive.
For a full list of the CE marking (and some non-CE marking) Directives, see our detailed directives pages.
For more information about standards, see our detailed standards page.
What can I do myself?
Generally, you can do everything yourself because the CE marking procedure is one of self-certification. The only cases where it is not possible for the manufacturer/importer to do everything themselves are when the relevant directives specifically state that a Notified Body must be involved in the assessment of the products. These are organisations designated by national governments of the member states as being competent to make independent judgments about whether or not a product complies with the essential safety requirements laid down by the directives. However, you may find it beneficial to engage the services of Conformance Ltd (or another consultancy) to help you through the process.
What does the CE logo mean?
The CE logo is affixed to the product at the end of the CE marking process and is a declaration by the manufacturer/importer that the product meets the essential requirements of any applicable CE marking directives. It has a specific format and must be kept in the correct proportion and have a minimum height of 5mm. You can download the logo in various formats and find out a little more about it on our CE logo page.
What does Conformance do?
Conformance is an independent consultancy that specialises in assisting manufacturers and importers to correctly navigate the CE marking procedure and ensure they have met all of their obligations. There is significant effort and time required to understand the CE marking procedure and to correctly fulfil the requirements contained in it. As an alternative to doing this "in-house", Conformance can offer a very competitive and complete service. However, as CE marking is a self-certification procedure, Conformance can only assist companies to fulfil their obligations - it cannot, for instance, sign Declarations of Conformity on behalf of its clients.
For a full description of the services we offer, please see our services.
Dictionary of Terms
On first acquaintance the subject of CE marking is littered with new phrases or words that have particular meanings and are occasionally confused! The following brief list contains some of the key phrases and their definitions. You can also click on the phrases to take you to a more detailed area of our site on the particular subject.
CE mark -This is the manufacturer/importer’s declaration that the product has met the essential requirements of the applicable CE marking directives. It is not a ‘safety’ mark as such and is not actually for the direct benefit of the consumer.
Technical File – Whoever placed the CE mark on the product should have the necessary documentation to demonstrate the essential requirements of the applicable directives have been met. This is what the technical file does, so it should contain all design info, test results, assessments, etc
Declaration of Conformity – As well as placing the CE mark on the product and producing a technical file, the manufacturer/importer must also produce and sign a Declaration of Conformity. This is a single page document ‘summing up’ the CE marking process that has been followed. So, it should list who the manufacturer/importer is, what equipment it refers to, which directives have been met and which standards have been used to demonstrate compliance. It also must contain a signatory of the person responsible for the CE marking of the product!
Declaration of Incorporation – This is specifically for products under the Machinery Directive that are sold in a non-complete state, to be incorporated into a complete machine. Basically, when the product being sold is part of a larger complete unit, it may not itself have all the required safety features, but will meet the essential safety requirements of the Machinery Directive when finally installed. In these cases, the machine can be issued with a Declaration of Incorporation and a specification for its installation, so the customer knows it meets the requirements as far as it can. The essential requirements which have not been covered by the manufacturer should be listed on this document.
Directives – Legal documents published by the European Commission that lay down requirements for Member State Governments to include in their national laws. Some of them require CE marks, but most do not. They cover a massive range of subjects, but our website is only interested in CE marking and closely related directives. The CE marking directives are rather vague and the legislative structure they set up includes specific provision for standards to be written to contain the working detail.
Standards – Documents published by various committees that specify design requirements and tests. Harmonised standards are often used as a method of demonstrating that a product meets the essential requirements of CE marking directives. In terms of CE marking, the use of standards is generally optional but sensible/easy.
Harmonisation/Harmonised standards – In this sense, harmonisation is the term for the acceptance of something throughout the EU. In terms of standards, a ‘harmonised standard’ is one that is the same throughout the EU, barring the language. So a German and French manufacturer producing the same products would work to the same standard. When a standard is accepted by the European Commission and it is referenced in their Official Journal, it is considered harmonised to the referenced directive. In these cases, meeting the requirements of the harmonised standard gives a presumption of conformity that the essential requirements of the directive have been met – this is why the CE marking process generally involves meeting the requirements of standards.
Essential Requirements/Essential Safety Requirements/ESRs – These are the main points in the directives that must be met before you can claim you have complied with the directive. They are generally expanded in detail in harmonised standards, but it must be borne in mind that it is always the ESRs of the directives that you must meet.
Notified Body – These are government appointed test houses that have a particular status when assessing certain products to specific CE marking directives. Generally, CE marking is a self-certification process, but some directives specifically demand the involvement of a Notified Body. Their word is basically law on determining whether a product meets the requirements of the directives or not.
Checklist –The crux of the Technical File is proving that the product meets the ESRs of the applicable directives. A way to do this is to create checklists of the requirements (of the directives and/or standards) and record how the product met these requirements. Also, if a product does not meet any particular clause of a standard but arguably still meets the ESRs, the checklist is a good place to document the argument.