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 to you 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, and if they install it as per the manufacturers instructions it will meet all the essential requirements.
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 are 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.