CE Mark Frequently Asked Questions

What is CE Marking?

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 is the CE marking process?

  • Identify the Directive (s) that are applicable to your product
  • Identify the conformity assessment procedure for your product and Directive
  • Determine the dates by which you must take action
  • Identify if there are any Harmonised European Standards applicable to your product
  • Ensure  the product complies with all the essential requirements of the Directive(s)
  • Identify whether independent assessment of your conformity is required by a Notified Body
  • Maintain Technical Documentation required by the Directive(s)
  • Prepare the Declaration of Conformity and the required supporting evidence
  • Check that no other purely national requirements exist in the country where the product is to be sold  
  • Affix CE marking on your product and/or packaging

What are the New Approach Directives?

The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonise product safety requirements across Europe.

The directives cover a very wide range of product areas including toys, medical devices and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user.

Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product. CE marking requirements vary from Directive to Directive, and even within Directives.

Third-party testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturer's unverified claim is all that's asked for. But beware! If you claim your product complies and it doesn't, you will be prosecuted.   Where a Directive requires products and/or systems to be independently tested, certified, or inspected, this must be done by a "Notified Body" or "Competent Body".  

What is a Notified Body?

A Notified Body is an organisation that has been nominated by a member Government and Notified by the European Commission. A Notified Body will be nominated based on designated requirements, such as knowledge, experience, independence and resources to conduct the conformity assessments.  

The primary role of a Notified Body is to provide services for conformity assessment on the conditions set out in the New Approach Directives in support of CE marking. This normally means assessing the manufacturers conformity to the essential requirements listed in each directive. Conformity assessment can be inspection, quality assurance, type examination or design examination, or a combination of these. BSI is a Notified Body for many European Directives.

What are the benefits of CE marking?

The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives.

Often customers will look for CE marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality that other products may lack.

 

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).

Why choose BSI?

As such BSI has a wealth of experience in helping companies to attain CE marking for their products. Our technical experts are available to help guide you through the process to make it as painless as possible