CE Marking and EU Directives - frequently asked questions

What is CE Marking and what are EU Directives? Find out more with our frequently asked questions...

 

What is CE marking?

CE marking on a product is mandatory. It proves it meets minimum legal requirements of the relevant Directive, which allows it to be placed legally on the market in any European member state. CE marking gives your company easier access into the European market to sell your products without adaptation or rechecking. 

What are EU Directives?

An EU Directive is a form of legislation that sets out requirements your products must meet in order to sell them into Europe.

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 harmonize product safety requirements across Europe.

The directives cover a very wide range of product areas including construction products, personal protective equipment 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".

We are a UK notified body for 17 EU Directives, which means we can provide you with professional guidance on how to meet all the essential requirements, so that your product can be bought to market quickly. We also offer one of the most comprehensive services in the world, enabling you to confidently and legally affix the CE mark to your products.

What is the CE marking process?

You will need to:

  • 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, such as BSI
  • 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
  • Contact us to arrange for testing of your product
  • If all requirements are met, you can then affix the CE mark on your product and/or packaging

 Why do you need a Notified Body for CE marking?

If a Directive requires products or systems to be independently tested, certified or inspected, you'll need a Notified Body for CE marking.

We will assess whether your product conforms to the essential requirements listed in the relevant directive. This might be inspection, quality assurance, type or design examination, or a combination of these. As well as helping you to prove your product meets the Directive, you’ll benefit from our expert knowledge, experience, independence and resources.

 What are the benefits of CE marking?

CE marking allows you to sell your product in the countries of the European Economic Area (EEA). By implementing the requirements you may also find that your product is safer and more reliable; therefore reduce the risk of customer dissatisfaction.