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Stages of Process

 

It is a good idea to be aware of the requirements contained in the different directives that apply to the product before its manufacture in order to incorporate the necessary compliance measures right from the design of the prototype phase. This reduces the costs and the time incurred in creating a compliant product.

It should be noted that product conformity is limited to the uses and purposes indicated by the manufacturer and other foreseeable uses, but does not cover arbitrary uses.

This diagram shows the different possible phases that a product has to pass through from its manufacture to its being placed on the market. Each directive may contain specific requirements.

Process phases CE Marking

 

When the involvement of a Notified Body is not compulsory, the manufacturer can choose whether or not to use a third party to oversee the examination and certification process.

Complex facilities and equipment are often required to carry out the examinations to assess a product’s potential risks and verify whether the solutions adopted are adequate.

The manufacturer may not have such facilities available due to the substantial costs involved and the high level of training required for specialised personnel. Testing laboratories and research centres are available within the European Union which help the manufacturer ensure the compliancy of their product, therefore enabling it to be placed on the market.