Whether you are new to product compliance or in need a quick refresher, here are some key FAQs on the CE mark and product conformity. If you have a burning question that is not on this page, then please contact us with our Ask A Question form or call the technical team on 01564 792349!
Please don’t forget that the requirements for CE Marking can be differ between products and we have kept our FAQs relatively generic to apply to as many products as possible. So please always ensure that you refer back to the relevant Legislation for your product specific requirement. If you need any advice, then please give us a call on 01564 792349.
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If you are a member of the Association and you have got a question on CE Marking or product conformity, then why not send your e-mail directly to the technical team. Please note that this e-mail address is reserved only for members of the Association and the e-mail filter will unfortunately block non-member questions. If you are a non-member, then please use the form above or why not become a member?
You need to establish first which, if any, of the New Approach Directives or older Global Approach Directives applies to your product. CE marking only applies to products within the scope of these Directives. It should not be applied to products if they are outside the scope of the Directives.
For specific information on the Directives, guidance notes are available by BIS, direct links within the members area.
The same principles above apply to imported products. It is the responsibility of the importer / person placing the product on the market to ensure that the product is correctly CE-marked.
It is necessary first to establish which Directives apply to the product. It is impossible to draw up hard-and-fast rules, and it is important to seek independent and impartial advice if you are in any doubt. Guidance booklets on many of the EC Directives (or UK regulations implementing those Directives) that contain CE marking requirements are available.
It is important also to understand that not all EC Directives relating to products, e.g. the General Product Safety Directive, require CE marking, nor that a particular Directive applies to all products that could be described by its title e.g. the Machinery Directive does not apply to every conceivable product that might be termed a machine. Most of the Directives set out ‘scopes’ i.e. the range of products to which they apply.
You should therefore study the UK regulations implementing the Directives. Copies of the regulations can be obtained from The Office of Public Sector Information (OPSI).
In general CE marking must appear on the product but see the individual guidance for exceptions. It may also appear on the packaging, in manuals or other supporting literature, but again it is best to study the guidance.
These are bodies appointed by each member State under the appropriate national regulations to conduct third-party conformity assessment procedures to the product in question or its production processes, as required by the Directives, in order that it may be CE-marked. The procedures vary according to the Directives and third-party involvement is not compulsory for all products. Manufacturers can use the services of Notified/Approved/Competent Bodies in any member State of the European Community.
The list of Notified Bodies can be found on the New Approach Notified and Designated Organisations (NANDO) website that forms part of the European Commission’s website. http://ec.europa.eu/enterprise/newapproach/nando/index.cfm
CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials “CE” do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Directive(s).
What files / documentation must I keep? What information should those contain? Ditto the Declaration of Conformity.
Please refer to the specific Directives and/or Regulations, and also the guidance documents available from BIS.
The CE mark must not be less than 5mm in its vertical height, and the proportions maintained. It is generally shown on a grid in the guidance booklets, as at the top of this page (the grid does not form part of the marking and is for information only):
This mark looks the same as some previous marks, but there are subtle changes, and it should be studied closely. It should be noted, for example, that the C and E are not formed by perfect semi-circles, i.e. the top and bottom arms extend one square beyond the semi-circles, and the middle arm of the E stops one square short.
CE-marking applies to the circulation of a product within the EEA. It is not required for exporting a product to non-EEA countries. You need to check on the particular regulatory requirements or standards that apply to your product in the country in question. The same standards may apply but they may also be different.
Advice on exporting is available from the UK Trade & Investment network, which delivers services co-ordinated by the former British Trade International, the organisation set up in May 1999 to take lead responsibility within Government for trade development and promotion.
The Technical Help for Exporters service run by the BSI may also be able to offer some advice.
Lists of standards that provide a presumption of conformity with the EC Directives for the purposes of CE marking are available from the “New Approach” website. Copies of the standards can be ordered from BSI.
Technical help is available from several sources including BSI, your Trade Association, and UK Trade & Investment
Enforcement varies according to the Directives. Some are enforced by local Trading Standards Departments , others by HSE and yet others by the Medical and Healthcare Products Regulatory Agency and the Vehicle Certification Agency.
Enforcement procedures/penalties: Except where safety is at risk, the relevant enforcement authority will usually provide you with an opportunity to ensure that your product is correctly CE-marked. If you fail to comply then you will be obliged to take your product off the market, and you may also be liable to a fine and/or imprisonment.