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 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 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".
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.
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 our services as we're a Notified Body for CE marking for many European Directives. This means here at BSI we've been nominated for CE marking by the Government and Notified by the European Commission based on our expert knowledge, experience, independence and resources.
If you're a manufacturer, we'll 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.
What are the benefits of CE marking?
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. CE marking gives your company easier access into the European market to sell your products without adaptation or rechecking.