Compliance

The Manufacturer or Supplier should demonstrate that the product complies with the essential requirements, using one of the product conformity assessment modules available within the directive. One of the options is usually the assessment of the product by applying the relevant standards to the product, and/or the preparation of appropriate documentation such as the Technical File. The CE Mark should be affixed legibly and indelibly to the product. The manufacturer should prepare and sign a “Declaration of Conformity”.

Many of the CE Marking directives include provision for the appointment of Notified Bodies. These are organizations appointed by Member States in which they are based and whose details are “Notified” to the European Commission. The Commission must then publish these details in the Official Journal of the European Communities.
Notified Bodies perform specific functions, as defined by the directives, in relation to the assessment of compliance of specific products. For many of the directives their involvement is only mandatory for higher risk and safety critical products.

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