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 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.
Having independent testing and assessments carried out is the safest way for manufacturers to proceed, whether this is mandatory or not. This helps you to claim a defence of due diligence.
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?
For further information about European Directives, please contact us.
