WHAT IS A CE CERTIFICATION?

CE marking is basically the passport of products and services to be sold in European markets. The letters CE are abbreviations of the French phrase “Conformité Européene” which translates from French to English as ‘European Conformity’ The term was first used as ‘EC mark’ and was later officially replaced by ‘CE marking’.

IMPORTANCE OF CE MARKING

If you intend to trade in the EU, CE-marking is a mandatory conformity mark required for a wide variety of products. It does not define the quality but represents that the product is safe and eligible to be distributed in European markets.

CE marking declares that the products abide by the requirements of European health, safety, and environment protection.

While for some products, CE Marking Certification is essentially a declaration by manufacturers that a product meets all applicable legal provisions set by the European Union under the CE Marking requirements, other products must be tested by a company that offers CE marking services, this indicates that a product has passed and compliant to EU product safety directives. CE marking certification allows these products to be legally sold anywhere within the EU and the European Economic Area. It also indicates to the European government that the products can be legally placed in their market.

Our CE-marking conformity assessment services provide you with the expertise you need to achieve compliance as We have helped countless manufacturers understand and meet the requirements of relevant New Approach Directives for CE Marking.

HOW URS CAN HELP IN OBTAINING THE CE CERTIFICATION?

URS engineering experts provide support and guidance at every point during the design process to ensure products comply with market requirements – through design review and pre-compliance testing, full testing to Standards and stringent professional assessment.

To ensure and declare the compliance of equipment, manufacturers must follow the conformity assessment procedure described in the Directive, which consists of the following elements:

  • Technical file – includes all technical documentation and its provision determines whether a product complies with the requirements
  • Declaration of Conformity – creating and signing a Declaration of Conformity before placing the equipment on the market.
  • CE mark – affixing the “CE” label on the product.

URS has developed a six-step method guiding you through every step of the CE marking requirements

STEPS TO CE CERTIFICATION

  • Determine which directive(s) are applicable to your product
  • Establish and fulfil the essential testing and safety requirements
  • Creation of technical reports and other documentation
  • Guiding through the entire Technical file preparation
  • Creation of Declaration of Conformity
  • Hazard and Risk Assessment, if you need our help at the outset, we can advise on any areas that may need attention.

WHAT IS THE CONTENT OF THE TECHNICAL DOCUMENTATION?

The technical file must always be up to date. This means that if there are any modifications to the product or amendments in the relevant directives/regulations, manufacturers should update the content of the file. The contents of the technical documentation differ between the different CE-marking directives.

However, as a rule, the documentation should include at least the following elements:

  • A general description of the product.
  • Conceptual product design and manufacturing drawings and, where appropriate, schemes of components, circuits, etc.
  • Descriptions and explanations needed for the understanding of those drawings and schemes.
  • A list of the harmonised and non-harmonised standards applied in full or in part during the conformity assessment process.
  • Test reports and risk assessment file.
  • Copies of conformity documentation for critical product components.
  • Instructions for use and manuals.
  • A copy of the Declaration of Conformity.

URS offers a one-stop solution for CE marking, meaning you access the EU market for the following directives: