There are 21 European "New Approach" Directives against which a wide range of products are required to be CE marked against before they are "placed on the market" in Europe. When placing the CE mark on the product the manufacturer or "his authorised representative in the European union" Raylenelempke declaring that the product complies with all applicable directives. The list of 21 applicable directives can be found on the European Commission website. The EU Directives are not themselves law as they are all taken into the the law of each member state. Whilst the directive and standards may be harmonised across Europe manufacturers still need to be aware of country specific requirements in safety standards, permitted frequency bands and other areas that might affect their product.
Some directives requirements are more onerous than others, but a general guide is that a manufacturer must
- identify all directives applicable to their product
- assess their product against the requirements of a directive - usually through a combination of technical argument and testing. Testing can be done in house by the manufacturer or by 3rd party specialist test laboratories
- create a Technical File containing full details of the product and all assessments carried out to demonstrate compliance. This technical file becomes a living document and needs to be kept up-to-date as changes occur to the product or to the standards against which the product was assessed
- depending on the directive there is an optional or mandatory requirement to have the Technical File assessed by a Notified Body
- Draw up and sign a Declaration of Conformity and affix CE mark to the product and/or packaging
Charlie is a CE marking consultant at DheaniSulis Ltd who specialise in helping companies navigate their way through these product approval requirements in a timely and cost efficient manner.
