CE marking and conformity with EU requirements is a complex topic. If your equipment does not fully meet all requirements you may have problems with clients and enforcement agencies. CCQS can provide advice on routes to conformity and requirements for design and documentation and will ensure that you are conforming with all necessary Directives and applying the correct standards.
Although a CE marking is generally perceived as a safety marking, it is in fact a Free Trade marking. The intent of CE marking Directives is to ensure that the same product can be offered for sale anywhere in the EU by ensuring that technical requirements are the same for all EU member states.
If a product carries a CE marking, the manufacturer or importer is claiming access to the EU market because the product meets all the relevant requirements of all relevant Directives.
CE marking Directives cover a variety of different types and aspects of equipment. This includes:
CCQS specialises in Personal Protective Equipment, Machinery, EMC for electronics Directives. These cover most industrial and consumer products, but we know a lot about other Directives as well, so even if we cannot help you directly, we may be able to provide some useful advice or point you to someone else who can help.
Not absolutely all products are covered by CE marking Directives but, those which are not still fall within the scope of the General Product Safety Directive. This places a duty on manufacturers and importers of equipment to ensure that these products are safe in normal and intended use.
CE marking Directives contain Essential Requirements which are the fundamental basis of conformity. Technical details of how the requirements can be met are provided by EN harmonised standards.
For most equipment, manufacturers can make their own assessment of whether their equipment meets the requirements of the Directives but in some Directives or for some classes of equipment it is necessary for a Notified Body to inspect the items and give some kind of certification.
Next page: Preparation Of Technical Files