Guide to CE Marking

CE marking is the European Union’s solution to the problem of technical barriers to trade with and within the EU.   The CE mark is surprisingly not a trade mark nor a sign of quality.  It is simply the means that manufacturers use to demonstrate that they have met all their obligations under the relevant European laws for their products.  These laws are ratified by the European Parliament and written into what are known as EC Directives.  These Directives set down the basic safety requirements (or requirements for general well-being) that products placed on the market must satisfy. 

No detailed technical requirements are set down in the Directives and the function of standards is separate from what are known as the “essential protection requirements” of the Directives. Standards support the Directives acting as a source for design and development.  They also act as the basis by which manufacturers can demonstrate that they have met the essential protection requirements of the relevant Directives. 

The essential objective of the EU conformity procedures is to enable the EU’s regulators to ensure that the product conforms with the directives with regard to health and safety of users and consumers. As a general rule, a product should be subject to the checks in the design process and if positive placed on the market.

 One of the most common conformity assessment procedures is summarized as follows:

 Step 1:  Determine which Directives apply

 Step 2:  Determine what conformity processes apply

 Step 3:  Determine what technical assessments apply. This step is derived for the Directives and the applicable standards.

 Step 4: Prepare the technical reports and technical file. 

 Step 5: Sign a Declaration of Conformity/Incorporation

 Step 6: Mark the product with the CE mark and place it on the market in the EU.

 Step 7:The Declaration of Conformity/Incorporation and technical file are made available to the relevant EU authorities on their demand, usually during an audit.  These documents may be held by the importer or manufacturer as Authorized Representative or an agent appointed by the importer or manufacturer.  The technical file may be held outside of the EU.

For further information on bringing your product in to conformity with the EU’s Directives and harmonized standards please contact us.

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