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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. 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. However, if you claim your product complies and it doesn’t, you may be prosecuted. Having independent testing and assessments carried out is the safest way for manufacturers to proceed, whether this is mandatory or not. This will help you to claim a defense 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”. A Notified Body is an organization that has been nominated by a member Government and Notified by the European Commission. 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 typically 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 17 European Directives.
EU Directives:
BSI is a Notified Body for 17 European Directives:
BSI can also offer Notified Body Services for the In Vitro Diagnostic Medical Devices Directive - 98/79/EC, through a partner.
Other European Directives, which BSI is not a Notified Body for include:
- Cableway Installations for Passengers - 2000/9/EC
- Energy Efficiency: Household Refrigerators & Freezers - 96/57/EC
- Explosives for Civil Uses - 93/15/EEC
- Packaging and Packaging Waster - 94/62/EC
- Recreational Craft - 94/25/EC
- Simple Pressure Vessels - 87/404/EEC
- Toys - 88/378/EEC
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