CE Marking
 Compliance system overview
In 1985 the European Community established a uniform marking system known as the CE marking system, with the intent to ensure free movement of products between Member States and remove internal barriers to trade.
Current member states include Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, the United Kingdom, Austria, Finland, Sweden, Iceland, Liechtenstein and Norway.
Countries under consideration for joining the EU include the Czech Republic, Cyprus, Estonia, Hungary, Malta, Poland, Slovenia, Turkey, Bulgaria, Latvia, Lithuania, Romania and Slovakia.
The CE Marking is a legally required marking in the European Union (EU) that applies to a variety of product categories. It is not a third-party certification mark, but placed on the product by the manufacturer or the manufacturer’s representative (e.g. an importer) residing in Europe. The marking indicates that the product complies with the applicable European legislation related to health, safety, environment and consumer protection.
Directives
Directives are binding pieces of EU legislation that Member States are legally obligated to implement into their own legal systems. The scope of each Directive defines the range of products covered by that Directive, as well as the products excluded from the scope. Each Directive lists essential requirements that must be met for the product to be considered in conformity with the Directive. To prove conformity the manufacturer may apply harmonized standards, which are written to address specific technical aspects of individual products.
Each Directive defines procedures for the assessing conformity of design and production of a product with the Directive. Some of the Directives require the intervention by an appointed Notified Body or Competent Body. The documentation required by the Directives also demands a lot of a manufacturer. EU documentation must be kept for 10 years after the last date of production.
UL services supporting CE Marking
Education - Market Access Solutions can assist manufacturers in identifying the applicable Directives and harmonized standards for their products. Market Access Solutions also can provide guidance on application of the Directives, including the steps to affix the CE Marking.
Informative Test Report (ITR) - A UL test report documenting test results that is used in third-party certification processes and may also be included in technical documentation to provide a robust platform for the CE marking.
Testing of individual components - If a manufacturer wishes to replace the supplier of an individual component, material or sub-assembly, or merely wishes to ensure that the purchased parts can be used in a particular product without negatively affecting safety, it is a good idea to have UL evaluate these components and materials. The manufacturer gains added confidence, and develops an additional level of trace ability.
Certificate of conformity - UL can issue a certificate that indicates conformity of a product with the relevant requirements, for example, to the Low Voltage Directive, for which UL is a Notified Body.
Testing according to the machinery directive - UL International Demko A/S is a Notified Body for the Machinery Directive and may issue a Type Examination Certificate for Annex IV (special machines and safety components) under the Machinery Directive.
Testing according to the Medical Device Directive (MDD) and In-Vitro Diagnostic Medical Device Directive (IVDD) - UL International (UK) Ltd. is a Notified Body under the MDD and IVDD.
Testing according to the EMC Directive - UL International Demko A/S is a Competent Body under the EMC Directive and tests and certifies to Articles 10.1 and 10.2 of the EMC Directive.
Testing according to the ATEX Directive - UL International Demko A/S is a Notified Body for the Potentially Explosive Atmospheres Directive and may issue a Type Examination Certificate and provide production verification under this Directive.
For further information
Should you have questions about UL's Market Access Solutions in Europe, require additional information, or wish to pursue any of these services, please contact us.
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