The Basics of CE Marking

The CE marking process can seem very confusing and complicated upon first acquaintance. Our website offers a wealth of information to explain some fundamentals of the CE marking process, background history, specific detailed information about each CE marking Directive and what services Conformance offer.

However, if you are completely new to CE marking, the following questions and answers offer a good start.

See also our CE Marking project workflow chart.

"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

The point of CE marking is to provide controls on product design, with the principal objective being to provide a 'level playing field' for product safety 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.

Introduction to CE Marking

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 Directive pages.

If the product falls under at least one of the CE marking Directives and is not specifically excluded by the directive(s), yes to both. However, as the Directives cover a very large range of products it is not practical to write a list of all the included and excluded product types here. However, the information contained in our individual Directive pages give more detailed information. 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).

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 thier fields. These standards are implemented at national, European or international level and some are ultimately adopted by the member state governments to specify the requiements 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. 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.

CE Marking Directives
CE Standards

You need to demonstrate that you have fulfilled the essential requirements of any relevant directives. This is in two parts; Protection requirements and Administrative requirements. The protective requirements relate to the design of the product and can be demonstrated by meeting the requirements of the relevant 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.

Introduction to CE Marking

Generally yes, as the CE marking procedure is one of self-certification. The only cases where it is not possible for the manufacturer to do everything themselves are when the relevant directives specifically state that a Notifed 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.

Conformance is an independent consultancy which specialises in assisting manufactuers and importers to correctly navigate the CE marking procedure and ensure they have met all their requirements. There is significant effort and time required to understand the CE marking procedure and to correctly fulfill the obligations 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 fulfill their obligations - it cannot, for instance, sign Declarations of Conformity on behalf of its clients.

Working with Conformance - the process

No. The main reason for this is that when Notified Bodies test products they are not permitted to provide any design assistance relating to the product. By not being a Notified Body, Conformance can give its clients a much more comprehensive service in this regard. It cannot, however, perform the role of a Notified Body and so sub-contracts any such work as required.

Notified Bodies